579344 research-article2015
CNRXXX10.1177/1054773815579344Clinical Nursing ResearchBastani
Article
Effect of Acupressure on Maternal Anxiety in Women With Gestational Diabetes Mellitus: A Randomized Clinical Trial
Clinical Nursing Research 1–17 © The Author(s) 2015 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1054773815579344 cnr.sagepub.com
Farideh Bastani, PhD, MSc, BSc1
Abstract Women with diabetes often experience a higher level of anxiety. The aim of the study was to evaluate the effect of acupressure on relieving anxiety of women with gestational diabetes mellitus (GDM). A randomized clinical trial was conducted on 60 women with GDM at a university hospital. The participants were allocated to an experimental and a placebo group (30 women per group). The experimental group received a nurse-provided acupressure at the true point, and the placebo group received pressure (touching) at a sham (false) point. Anxiety was measured immediately in the groups prior to and after a 2-day intervention by a questionnaire and the Visual Analogue Scale. The data were analyzed using descriptive and inferential statistics. Results indicated that the acupressure group had significantly lower anxiety than the placebo group (p ≤ .0001). In conclusion, the effects of acupressure appeared to be effective in reducing anxiety in diabetic pregnant women.
1Iran
University of Medical Sciences, Tehran, Iran
Corresponding Author: Farideh Bastani, School of Nursing & Midwifery, Department of Maternal–Neonatal Health Nursing and Department of Geriatric Nursing, Iran University of Medical Sciences, Tehran, Iran. E-mail: [email protected]
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Keywords acupressure, anxiety, diabetes, health, pregnancy
Introduction As pregnancy can be both an exciting and worrying time for mothers-to-be, they experience a range of physical and emotional changes, which may trigger stress and anxiety (Correia & Linhares, 2007; Field et al., 2010; Qiao, Wang, Li, & Wang, 2012). Anxiety in pregnancy is the most potent maternal risk factors for adverse pregnancy outcomes (Dunkel Schetter, 2010; Thiagayson et al., 2013). It has been reported that pregnant women with gestational diabetes mellitus (GDM) experience higher anxiety and stress levels than do non-pregnant women and healthy pregnant women (Hayase, Shimada, & Seki, 2014; Yogev, Metzger, & Hod, 2009). Despite the increases in attention to psychological state of pregnant women, pregnant women frequently do not receive prevention or treatment for anxiety and stress concerns (Flynn, Blow, & Marcus. 2006). Antidepressants and anxiolytics can harmfully affect the fetus and thus are not “safe” during pregnancy. They should be replaced by non-pharmacologic treatments whenever possible (Campagne, 2007). Acupressure, a treatment method in Chinese medicine, has been reported in randomized clinical trials (RCTs) and systematic reviews to be useful in alleviating the symptoms of various health problems including anxiety in a variety of patient populations (H. M. Chen, Chang, & Hsu, 2005; Etri & Adib-Hajbaghery, 2012; Song, 2015). However, studies about the effects of acupressure on relieving health problems in pregnant women with GDM are scarce. In summary, considering the limited studies to support the efficacy of acupressure for anxiety reduction during pregnancy in women with GDM, the purpose of this study was to evaluate the effects of acupressure in reducing pre-natal anxiety and its severity in women with GDM.
Background GDM is the most common medical complications of pregnancy characterized by glucose intolerance with onset or first recognition during pregnancy (American Diabetes Association [ADA], 2009) affecting up to 25% of pregnancies in Asia (Tutino et al., 2014). Although the precise cause of GDM is unknown, during pregnancy, the evidence suggests that human placental lactogen (HPL) has growth hormone–like actions, and that it causes lipolysis and thereby increases the levels of circulating fatty acids that inhibit the action of insulin and cause insulin resistance in pregnant women (Tutino et al., 2014).
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It is reported that the women with high-risk pregnancy, including GDM (as a predictor of anxiety), would appear to be at a greater risk of experiencing anxiety because of the physical and psychological demands of their complicated pregnancies (Broussard, 2007). In a study conducted by Hirst et al. (2012), it was revealed that women with GDM who participated in qualitative focus groups reported feelings of increased fear and anxiety, largely because of lack of information around the disorder and perceived high-risk pregnancy. In this regard, maternal anxiety associated with pregnancy has been examined in Australian women’s reflections on the experience of having a pregnancy affected by GDM (Morrison, Lowe, & Collins, 2014). It was reported that the women have been more likely to experience shock, fear, or anxiety. It is also well documented that anxiety among pregnant women is a risk factor for adverse maternal and child outcomes (Field et al., 2010; Leight, Fitelson, Weston, & Wisner, 2010; Martini, Knappe, Beesdo-Baum, Lieb, & Wittchen, 2010). In pregnancy, during experiencing anxiety (as a dimension of stress), various hormones, including adrenocorticotrophin-releasing hormone, cortisol, noradrenalin, and beta-endorphin, are released in large quantities in the blood. Increased beta-endorphin levels have been reported to be associated with decreased utero-placental blood flow, resulting in fetal hypoxia (Mulder et al., 2002). GDM is also claimed to be associated with anxiety and poor pregnancy outcomes including caesarean delivery, pre-eclampsia and preterm birth, neonatal hypoglycemia, fetal hyperinsulinemia, birth injury (predominantly shoulder dystocia), neonatal hyperbilirubinemia, and neonatal intensive care unit admission (Dunkel Schetter, 2010; Yogev et al., 2009) and adverse outcomes in glycemic control (Herzer & Hood, 2010). There may be a synergetic effect of gestational diabetes and anxiety, despite substantial evidence to the contrary. In a case control study of 160 pregnant women with diabetes, anxiety symptoms increased the risk of diabetes significantly (Hasan et al., 2013). Thus, the methods used to control anxiety and enhance relaxation and comfort could result in physiologic changes such as lowering metabolism, muscle tension, and enhancing immune function (Tiran & Chummun, 2004). Indeed, research on the methods to decrease maternal anxiety is scarce. One approach to manage anxiety is acupressure, which is a non-invasive variant of acupuncture that has been shown to be useful for multiple symptoms management including anxiety in a variety of patient populations (H. M. Chen et al., 2005). By implementing this low-cost nonpharmaceutical intervention, significant reduction in anxiety in women with GDM could be hypothesized. To the best of our knowledge, no similar research focusing on this topic has been conducted or published.
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Women screened for eligibility (n=106) Excluded (n= 46) Not meeting inclusion criteria (n=31) Declined to participate (n=15) Randomized (n=60)
Allocated to experimental group [received acupressure] (n=30)
Allocated to placebo group [received touch] (n=30)
Dropped out from analysis [diagnosed with thyroid disease during hospitalization after first assessment] (n=1), [Recent stressful events in their lives] (n=1)
Dropped out from analysis [Discontinued touch due to personal reasons] (n=1)
Analyzed (n=28)
Analyzed (n=29)
Figure 1. Consort flow diagram indicating patient screening, intervention allocation, and analysis. Note. n = number of patients.
Materials and Method Study Design and Setting A single blind RCT was used in the study. The participating women were blinded in a way they did not know in which treatment option (acupressure or placebo) they were. The RCT was conducted at a large university hospital in Tehran, Iran. The flowchart of the patients passed through the trial is presented in Figure 1.
Participants One hundred six hospitalized women with newly diagnosed insulin-dependent GDM were screened to satisfy the selection criteria for participating them in the study. The reasons for the hospitalization (routinely 3 to 5 days) of the pregnant women were the close monitoring of the expectant mothers for insulin injection training, glycemic control, and fetal health assessment. Forty-six patients were excluded from the screening from which 31 did not meet the inclusion criteria, and the rest (n = 15) declined to participate. Sixty eligible
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women, who were matched by considering the specific potential confounders of age and familial history of diabetes, were recruited with a 20% sample loss. The power, effect size, and alpha were set at 0.80, 0.20, and .05, respectively, with the effect size of nearly 1. Equal study groups (experimental and placebo), each including 30 patients, were created by a block randomization. Of the total participating women (60), 3 participants (2 participants of the experimental and 1 participant of the placebo groups) were dropped out from the study and failed to complete the trial for data analysis. The inclusion criteria were (a) expressing anxiety (in the context of hospitalization of the women who were asked to express their feelings before their inclusion to the study), (b) singleton pregnancy, (c) young females (18-40 years), (d) gestational age between 20 and 42 weeks, (e) not smoking, and (f) not taking oral sedatives. The dropout reasons of the participants (n = 2) in the experimental group were (a) bad obstetric situations (newly diagnosed with thyroid disease), after the first assessment, during hospitalization and the trial (n = 1), and (b) a recent stressful event (n = 1). The reason of dropout in the placebo group was refusing the touch by the patient due to personal reasons (n = 1). The main exposure of the experimental group was acupressure, at the true point (P7), and the intervention of the placebo group was pressure (touching) at a sham (false) point by a certified nurse who had attended in an acupressure training course.
Procedure The study procedure was approved by the ethics committee of the university hospital in accordance with the ethical standards laid down in the 1995 Declaration of Helsinki. Written informed consent was obtained from the participants prior to their inclusion in the study. The participating women were also given verbal information before taking their informed consent. The primary outcomes were maternal anxiety and its severity, which were measured immediately in the groups prior to and after the completion of the interventions (during 3 days) to test the effectiveness of the nurse-provided acupressure on the anxiety of the women with GDM between August 2011 and October 2012. As mentioned earlier, there is a routine hospitalization of the women with GDM in university hospitals in Iran lasting for a period of 3 to 5 days for training them for insulin injection, close monitoring of the expectant mothers for glycemic control, and fetal health assessment. Thus, we had better access to the women over such period, and our acupressure treatment was limited to 3 days of the women’s hospitalization. Actually, we expected the women in the experimental group to learn and continue to apply the acupressure (if effective) for self-management of their anxiety at home.
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The women were randomized to two experimental (acupressure) and control (touch) groups by blocking randomization.
Interventions Both of the acupressure at the true point (for the experimental group) and touching at a false point (for the placebo group) were delivered by the same certified nurse simultaneously with a 30-min interval. Allocation concealment of the participants in the acupressure was applied. However, contamination of acupressure intervention among women in the placebo group might have been occurred, because acupressure was performed on the experimental group while the other patients (in the placebo group) were hospitalized at the same ward and underwent monitoring and treatment. In other words, there was a possibility that the patients allocated in the placebo group might have learnt to perform their own acupressure. However, that would not be comparable with the acupressure performed by the certified nurse, which was consistently applied according to the standardized protocol. The acupressure is a massage technique using fingers and palms with a certain amount of force to stimulate true acupoints and meridian lines (similar to the vascular system for the circulation of blood) on the surface of the skin. The acupoint Pericardium 7 (P7) was selected to receive the acupressure, because this acupoint is easily accessible, and if made effectively and necessarily, the acupressure at this point can then be learned and performed by the patient herself (Maa et al., 2007). Using this particular acupoint ensures that patients feel neither uncomfortable nor that their privacy is compromised. The experimental group received 3 days’ acupressure treatments on their forearms bilaterally within 2 days. The acupressure force was validated by applying the thumb pressure on a 3- to 5-kg scale, calibrated to national standards. For each pressure on each side, P7 pressure was continuously applied by the nurse’s thumb for a period of 3 min for each of the women’s wrist. This process was repeated 3 times a day to bring the total treatment time to 9 min for each forearm and 18 min for both sides per day according to a protocol reported by Maa et al. (2007) and Mehdizadeh (2002). Before performing the acupressure, the nurse used a scale to assess the degree of pressure applied by requesting her colleagues to observe the pressure for 10 s. This was done to ensure that the pressure was maintained within a 3- to 5-kg range until the patient reported a gentle tingling and numbness sensation. Those assigned to the placebo or sham group received the touching with the same frequency and duration of the acupressure group within the same days at a site on the wrong point, which was selected at 0.5 cm away from the true acupressure point (dorsal part of the left and right forearms) that is
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thought to be ineffective and has been used in other placebo controlled trials (Heazell et al., 2006; Werntoft & Dykes, 2001).
Assessment Instruments At pre-intervention, data were collected from both of the groups by using three different measurement tools. These included the Demographic and Clinical Questionnaire (DCQ), the Maternal Anxiety Questionnaire (MAQ), and a Visual Analogue Scale for the Severity of Anxiety (VASA).The Cronbach’s coefficient alpha was used to assess the internal consistency. The DCQ provides data corresponding to the maternal age, education level, employment status, economic status, parity, history of abortion, history of familial diabetes, and the plan of pregnancy. Comparisons were made between the maternal anxiety scores and the severity of anxiety 2 times before the first intervention and immediately after the last intervention of the hospitalized women with GDM (on third day) in the experimental and placebo groups. Maternal anxiety was measured using the MAQ (Ahadi, 2009) consisting of 15 statements describing various emotional states. The statements of the MAQ are scored on a 4-point Likert-type scale from “not at all” to “very much so” (with the scores of 1 to 4, respectively). The score from each item is then summed to give a total score ranging from 1 to 50. Higher scores indicate more anxiety in the women. Content and face validity of the MAQ were assessed by a group of scholars and experts to detect any unclear and misleading questions. When tested for this study, the MAQ revealed appropriate internal consistency (Cronbach’s α = .83). The VASA consists of a 10-cm horizontal scale with the descriptors of “no anxiety” written on the left and “worst possible anxiety” written on the right of the scale. Participants were asked to place a mark on the 10-cm rated line, at a point corresponding to the level of the anxiety intensity (severity) they felt at the time of enquiry. The VASA has been reported to be sensitive to pharmacologic and nonpharmacologic procedures that alter the experience of anxiety with favorable validity and reliability (Chang, Wang, & Chen, 2002). Visual Analogue Scale is a valid test for anxiety. It can be used alone or in combination with other measures to improve the assessment of anxiety. The patients with a VASA > 5.0 cm should be regarded as anxious. The VASA was administered pre-operatively by Facco et al. (2011) to 1,114 patients. The study confirmed that VASA is a simple, sensitive, fast, and reliable tool, and can be used effectively in the assessment of anxiety using the value of 5.1 as cutoff point.
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Data Analysis The collected data were processed using the SPSS for Windows, Version 15.0. The data were entered twice in the SPSS data file. The data were expressed as the numbers, n (%), or means accompanied with standard deviations, M (SD), as appropriate. The results were analyzed by the chi-square (or Fisher’s exact) test and t test. This study was designed to detect betweengroup and within-group differences. The chi-square test was used for the comparison of the experimental and placebo groups. Regarding the primary outcome measures (anxiety and its severity), the differences between the preand post-intervention scores were compared using the independent t test considered to be significant with p ≤ .05. The one-tailed paired t test was applied to estimate the pre–post intervention differences within the groups. All the variables displayed a normal distribution based on the Kolmogorov–Smirnov test.
Results In the study, two enrolled patients of experimental group and one patient of placebo group did not complete the study. Therefore, the patients were considered dropouts for technical or medical reasons. The analysis was thus based on 28 participants in the experimental group and 29 in the placebo group during the study. The two groups did not differ significantly regarding demographic and clinical variables (Table 1). All women in the study were married and in their second half of pregnancy. The average ages of the participants were 29.9 (SD = 6.41) years and 29.77 (SD = 6.55) years in the experimental and placebo groups, respectively. Tables 2 and 3 present the means and standard deviations on the scores of pre- and post-intervention of primary outcome measures. There were no significant differences between the groups regarding the mean scores of anxiety and its severity before intervention, ps = .65 and .84, respectively (Tables 2 and 3). Whereas, at postintervention, women participating in the acupressure group showed statistically significant decreases in anxiety (p ≥ .05) and its severity (p = .006) compared with the placebo group (Tables 2 and 3). In terms of the primary outcome measures (anxiety and its severity), in the acupressure group, there were significant decreases between the pre- and post-intervention mean scores in the anxiety on the MAQ and its severity on the VASA (p = .001) with the change difference of 3.96 points and 3.47 points, respectively. Although it should be noted that the mean score of anxiety on the MAQ remained unchanged (with the change difference of 0) in the placebo group, the reduction of the severity of anxiety on the VASA was
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Acupressure group n (%; N = 30)
Age (year) 40 1 (3.8) Education High school 16 (55.2) Diploma 8 (27.6) University 5 (17.2) Employment Employed 3 (10.3) Unemployed 26 (89.7) Economic status Good 1 (3.4) Moderate 24 (82.8) Bad 4 (13.8) Gestational age (week) 20-24 2 (69) 24-39 3 (10.3) 30-34 12 (41.4) ≥35 12 (41.4) History of familial diabetes Yes 8 (27.6) No 21 (72.4) Experience of spontaneous abortion Yes 9 (31) No 20 (69) Plan of pregnancy Planned 26 (89.7) Unplanned 3 (10.3)) Parity Primipara 12 (41.1) Multipara 17 (58.6)
Placebo group n (%; N = 30)
p value (Fisher’s exact test)
3 (10) 16 (53.3) 10 (33.3) 1 (3.3)
*(p = .07)
16 (53.3) 13 (43.3) 1 (3.3)
*(p = .15)
1 (3.3) 29 (96.7)
*(p = .35)
1 (3.3) 21 (70) 8 (26.7)
*(p = .59)
3 (10) 7 (23.3) 10 (33.3) 10 (33.3)
*(p = .27)
11 (36.7) 19 (63.3)
*(p = .45)
9 (30) 21 (70)
*(p = .93)
23 (76.7) 7 (23.3)
*(p = .29)
11 (36.7) 19 (63.3)
*(p = .71)
*Not statistically significant.
found significant (with the change difference of 2 points). In this study, a level of significance was selected (α = .05), which means there is only a 5% probability that the difference between the groups is due to chance. In this
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Table 2. Women’s Anxiety Level by Group at Pre–Post Intervention. Pre-intervention
Variable
Acupressure group
Placebo group
Acupressure group
Placebo group
n (%)
n (%)
n (%)
n (%)
Anxiety score (MAQ) Low (20-30) Moderate (31-40) High (41-50) Very high (>50) Total M ± SD t test
Post-intervention
4 (14.3) 5 (17.2) 13 (46.4) 15 (51.7) 11 (39.3) 7 (24.1) 0 (0) 2 (6.9) 28 (100) 29 (100) 37.35 ± 5.88 36.51 ± 7.84 *p = .65, df = 55, t = 0.45
7 (25) 5 (17.2) 19 (67.9) 14 (48.3) 2 (7.1) 8 (27.6) 0 (0) 2 (6.9) 28 (100) 29 (100) 33.3 ± 4.289 36.51 ± 7.28 **p = .05, df = 55, t = −1.96
Note. MAQ = Maternal Anxiety Questionnaire. *Not statistically significant. **Statistically significant.
Table 3. Severity of Anxiety Between Acupressure and Placebo Groups at Pre–Post Intervention. Pre-intervention
Variable Severity of anxiety (VASA) Not at all anxious (0) Mildly anxious (1-3) Moderately anxious (4-6) Severely anxious (7-9) Extremely anxious (10) Total M ± SD t test Change difference (anxiety) Change difference (severity of anxiety)
Acupressure group
Placebo group
n (%)
n (%)
Post-intervention Acupressure Placebo group group n (%)
n (%)
0 (0) 0 (0) 1 (3.6) 0 (0) 3 (10.7) 5 (17.2) 17 (60.7) 13 (44.8) 11 (39.3) 10 (34.5) 9 (32.1) 12 (41.4) 12 (42.9) 12 (41.4) 1 (3.6) 3 (10.3) 2 (7.1) 2 (6.9) 0 (0) 1 (3.4) 28 (100) 29 (100) 28 (100) 29 (100) 6.43 ± 2.16 6.31 ± 2.39 2.96 ± 1.55 4.31 ± 2.00 *p = .84, df = 55, **p = .006, df = 55, t = 0.195 t = −2.83 Acupressure group: 3.96 Placebo group: 0.0 Acupressure group: 3.47
Placebo group: 2.0
Note. VASA = Visual Analogue Scale for the Severity of Anxiety. *Not statistically significant. **Statistically significant.
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case, regarding the “clinical significance” about the importance of the finding, we used effect size. The effect size in the study was calculated, and it was approximately equal to 1, which is a type of practical significance.
Discussion The results suggest that acupressure during pregnancy resulted in a significantly greater decline in primary outcome measures (anxiety and its severity) in the experimental group compared with the placebo group at post-intervention assessment. All of the participants (women with GDM) were hospitalized in a pre-natal ward (as high-risk obstetrical ward) at a university hospital. The high-risk obstetrical patients who are hospitalized in maternity wards may commonly experience anxiety and stress (Byatt et al., 2014) which could be associated with altered physiological parameters regarding the release of glucocorticoids such as cortisol, releases the catecholamines, norepinephrine, and epinephrine (Obel et al., 2005). Therefore, the women with high-risk pregnancies including GDM may be at increased risk of mood disorders (Thiagayson et al., 2013). In other words, diagnosis of GDM could be considered a source of anxiety (Hjelm, Berntorp, Frid, Aberg, & Apelqvist, 2008); however, the relationship between anxiety and GDM and whether they are synergistic effects between them has not been extensively studied. In this study, there were no significant differences regarding demographic variables in the experimental and placebo groups. At pre-intervention, a large percentage of the anxious women were in their third trimester in the acupressure and placebo groups. This might be because of the higher level of the anxiety in the third trimester compared with the second trimester (A. M. Lee et al., 2007). Most of the participants were multipara, which could be a risk factor for the anxiety in pregnancy, as the women may be unable to function day to day (DiPietro, Sipsma, & Costigan, 2008). However, the presence of anxiety in the primipara women may be due to their adaptation to the challenge of becoming first-time parent. With regard to the primary outcome measures, there were no significant differences of anxiety and its severity between the groups before intervention. Whereas, at post-intervention, women participating in the acupressure group showed statistically significant decreases in anxiety and its severity compared with the placebo group. The results are congruent with the studies carried out by Agarwal et al. (2005) and H. M. Chen et al. (2005) in relation to the effectiveness of acupressure in decreasing patients’ anxiety. Whereas an opposite result has also been reported in another study (Ming, Kuo, Lin, & Lin, 2002) in which it is reported that acupressure is not able to successfully relieve anxiety. In terms of the primary outcome measures, the scores of the
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change difference of anxiety at pre- and post-intervention on the MAQ and the VASA were 3.96 and 3.47, respectively, in the acupressure group. Although it should be noted that the change difference of anxiety on the MAQ remained unchanged (0) in the placebo group and the change difference of the severity of anxiety on the VASA that reported on the 10 cm rated line on the Visual Analogue Scale was 2. Notably, when comparing the groups, this unexpected change difference (2) on the VASA in the placebo group was not greater than the change difference score (3.47) on the VASA in the experimental group. It seems that the women of both the groups were more likely to be motivated to use a technique to manage their anxiety. A study with the RCT design of the acupressure in individuals with anxiety has found an improvement noted in both of the placebo and acupressure groups (H. M. Chen et al., 2005). In this study, the sham placebo point was selected at 0.5 cm away from the true acupressure point; it seems that there might have been small beneficial effects of the intervention (touch) on the placebo group. This is consistent with the studies carried out by Chen (1996), and Tsay and Chen (2003) who found symptoms improvement (including anxiety) of acupressure on the sham point of their placebo group. Another explanation is that all of the participants were married in the study and may have been supported by their spouses, although not measured in this study. This may have assisted the anxious women to have a great motivation for problem solving and self-care management regarding their anxiety (Trief et al., 2003). It could also be concluded that being touched might play an important role in governing emotional well-being and comfort experience. In human beings, the skin contains receptors. Hence, when an individual’s skin is stimulated, for example, by touch or massage, endorphin levels are increased, which elicit a relaxation effect (Field et al., 2010). In other words, being supported and cared with touching in the placebo group may have allowed the women to feel in control and relaxed that could result in reducing anxiety (Ip, 1999). The intervention in the placebo (touch) has not been as effective as that of the acupressure group to decrease anxiety and the severity of anxiety. Applying acupressure in the women with GDM significantly reduced the severity of anxiety on the VASA with considerable change differences with a value of 5.1 as the cutoff point that could be considered clinically important. In addition, acupressure as an alternative therapy during hospitalization may also be associated with other clinical benefits such as the improved well-being and comfort of the women. This result is consistent with the conclusion of a systematic review related to 10 eligible studies assessing interventions with complementary and alternative therapy (CAT), including acupressure designed to reduce anxiety (Newham, Westwood, Aplin, & Wittkowski, 2012). They found that those in
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the intervention group were more likely to show a significant reduction in the post-intervention anxiety scores. Acupressure as a CAT, by stimulation of acupoints, may increase a release of serotonin and melatonin, which relaxes the body and consequently reduces the anxiety (Spence et al., 2004). It should also be noted that acupressure was popular with our participants, all of whom were grateful and looked forward to their next treatments. They particularly enjoyed the opportunity to discuss their feelings with the nurse and to have their symptoms recognized and accepted by health professionals. Because acupressure is a low-cost and easy technique for relaxation, it appears to be especially agreeable to participants; it is likely that this will enhance compliance in pregnant women in a long-term anxiety management. Thus, a longitudinal study is recommended to investigate the long-term effects of acupressure on anxiety in the women with GDM. Seemingly, anxiety could be significantly decreased during self-administered or professionally provided acupressure (Honda, Tsuda, Horiuchi, & Aoki, 2013). A survey of the literature has suggested that a single session of acupressure, provided by professionals, reduces anxiety (Agarwal et al., 2005; Honda et al., 2013). This study is unique as the results revealed that acupressure at true points (P7) can significantly reduce anxiety in hospitalized women with GDM, compared with a placebo group. Acupressure techniques can be easily learnt by patients so that they can manage relaxation themselves (Guerreiro da Silva, Nakamura, Cordeiro, & Kulay, 2005). In pregnant women with diabetes who tend to feel vulnerable to anxiety, it is important to establish a caring relationship and applying a technique to be empowered to manage their anxiety in a way to strive from normoglycemia and to reconcile with the disease (Berg, 2005). Therefore, our study could add support to the notion that the effect of acupressure on anxiety may be clinically worthwhile; because the costs and risks of acupressure are low, they can be considered for clinical use. Furthermore, the randomized controlled design was one of the strengths of this study. As there were no differences in women characteristics between the experimental group and the placebo group, the possible differences in the primary outcome measures could be ascribed to the intervention with more certainty. There have also been some limitations in this study that should be noted. We have to consider that the voluntary nature of the participation in the study may have led to a selection bias, in the sense that those women who agreed to participate, and also those who complied with the evaluations, may in fact be those who feel more involved in the study. This study conveniently selected the sample of only married women with GDM, focused on the self-report questionnaire for assessing subjective aspect of the anxiety in a short time of 3 days. Therefore, our study has limited generalizability due to marital status
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and reliance on the self-report measures. Moreover, if possible, the evaluation of the objective symptoms of anxiety with more prolonged period of acupressure could lead to more conclusive results, whereas only subjective anxiety and its severity were assessed in this study. Hence, future studies can be suggested to evaluate other outcomes such as glycemic control and pregnancy outcomes in women with GDM who receive acupressure. In conclusion, this study provides preliminary evidences on the effectiveness of short-term acupressure in reducing anxiety and its severity in hospitalized pregnant women with GDM.
Implications for Nursing Practice Nursing personnel as health care providers represent the largest component of the health care workforce in hospitals. They have a responsibility to help patients relieve their anxiety. They should be equipped, adopt evidence-based practices, and translate them into clinical settings. Despite the limitations of this study, it showed that the nurse-provided acupressure is an effective method to reduce anxiety in hospitalized women with GDM in short term. This has considerable implications for nursing practice, as acupressure is a low-cost and easy-to-learn technique that can be incorporated in the care planning of women with GDM. Declaration of Conflicting Interests The author declares no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author received no financial support for authorship, and/or publication of this article.
References Agarwal, A., Ranjan, R., Dhiraaj, S., Lakra, A., Kumar, M., & Singh, U. (2005). Acupressure for prevention of pre-operative anxiety: A prospective, randomised, placebo controlled study. Anaesthesia, 60, 978-981. Ahadi, M. (2009). A comparative study of maternal anxiety in Iranian primipara and multipara women (Doctoral thesis), Iran University of Medical Sciences, Tehran. American Diabetes Association. (2009). Diagnosis and classification of diabetes mellitus. Diabetes Care, 32, S62-S67. Berg, M. (2005). Pregnancy and diabetes: How women handle the challenges. Journal of Perinatal Education, 14, 23-32.
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Broussard, D. (2007). Predictors and correlates of anxiety in women hospitalized with high risk pregnancies (Doctoral dissertation). The University of Texas Southwestern Medical Center at Dallas. Byatt, N., Hicks-Courant, K., Davidson, A., Levesque, R., Mick, E., Allison, J, & Moore Simas, T. A. (2014). Depression and anxiety among high-risk obstetric inpatients. General Hospital Psychiatry, 36, 644-649. Campagne, D. M. (2007). Fact: Antidepressants and anxiolytics are not safe during pregnancy European. Journal of Obstetrics & Gynecology and Reproductive Biology, 135, 145-148. Chang, M. Y., Wang S. Y., & Chen C. H. (April 2002). Effects of massage on pain and anxiety during labour: a randomized controlled trial in Taiwan. Journal of Advanced Nursing, 38: 68-73. Chen, H. M., Chang, F. Y., & Hsu, C. T. (2005). Effect of acupressure on nausea, vomiting, anxiety, and pain among post-cesarean section women in Taiwan. Kaohsiung Journal of Medical Sciences, 21, 341-350. Chen, K. G. (1996). The science of acupuncture—Theory and practice. II. Electrical properties of meridians. Engineering in Medicine & Biology, 15, 58-63. Correia, L. L., & Linhares, M. B. (2007). Maternal anxiety in the pre and postnatal period: A literature review. Revista Latino-Americana de Enfermagem, 7(15), 677-683. DiPietro, J. A., Sipsma, H. L., & Costigan, K. A. (2008). Continuity in self-report measures of maternal anxiety, stress, and depressive symptoms from pregnancy through two years postpartum. Journal of Psychosomatic Obstetrics & Gynecology, 29, 115-124. Dunkel Schetter, C. (2010). Psychological science on pregnancy: Stress processes, biopsychosocial models, and emerging research issues. Annual Review of Psychology, 62, 531-558. Etri, M., & Adib-Hajbaghery, M. (2012). Effects of acupressure on pain and vital signs of patients following small abdominal surgeries: A clinical trial. Nursing and Midwifery Studies, 1, 67-71. Facco, F., Zanette, G., Favero, L, Bacci, C., Sivolella, S., Cavallin, F., & Manani, G. (2011). Towards the validation of Visual Analogue Scale for Anxiety. Anesthesia Progress, 58, 8-13. Field, T., Diego, M., Hernandez-Reif, M., Figueiredo, B., Deeds O., Ascencio, A., . . . Kuhn, C. (2010). Comorbid depression and anxiety effects on pregnancy and neonatal outcome. Infant Behavior & Development, 33, 23-29. Flynn, H. A., Blow, F. C., & Marcus, S. M. (2006). Rates and predictors of depression treatment among pregnant women in hospital-affiliated obstetrics practices. General Hospital Psychiatry, 28, 289-295. Guerreiro da Silva, J. B., Nakamura, M. U., Cordeiro, J. A., & Kulay, J. R. (2005). Acupuncture for insomnia in pregnancy—A prospective, quasi-randomised, controlled study. Asian Institute Management, 23(2), 47-51. Hasan, S. S., Thiruchelvam, K., Ahmed, S. I., Clavarino, A. M., Mamun, A. A., & Kairuz, T. (2013). Pregnancy complications, mental health-related problems, and type 2 diabetes mellitus in Malaysian women. Journal of Diabetes. Metabolic Syndrome and Obesity, 7(4), 191-197.
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Hayase, M., Shimada, M, & Seki, H. (2014). Sleep quality and stress in women with pregnancy-induced hypertension and gestational diabetes mellitus. Women and Birth, 27, 190-195. Heazell, A., Thorneycroft, J., Walton, V., & Etherington, I. (2006). Acupressure for the in-patient treatment of nausea and vomiting in early pregnancy: A randomized control trial. American Journal of Obstetrics and Gynecology, 194, 815-820. Herzer, M, & Hood, K. K. (2010). Anxiety symptoms in adolescents with type 1 diabetes: Association with blood glucose monitoring and glycemic control. Journal of Pediatrics and Psychology, 35, 415-425. Hirst, J. E., Tran, T. S., Do, M. A., Rowena, F., Morris, J. M., & Jeffery, H. E. (2012). Women with gestational diabetes in Vietnam: A qualitative study to determine attitudes and health behaviours. BMC Pregnancy and Childbirth, 12, Article 81. Hjelm, K., Berntorp, K., Frid, A., Aberg, A., & Apelqvist, J. (2008). Beliefs about health and illness in women managed for gestational diabetes in two organisations. Midwifery, 24, 168-182. Honda, Y., Tsuda, A., Horiuchi, S, & Aoki, S. (2013). Baseline anxiety level as efficacy moderator for self-administered acupressure for anxiety reduction. International Journal of Prevention and Treatment, 2, 41-45. Ip, V. H. Y. (1999). The use of acupuncture for pain relief in a Chinese hospital clinic. Acupuncture in Medicine, 17, 101-109. Lee, A. M., Lam, S. K., Sze Mun Lau, S. M., Chong, C. S., Chui, H. W., & Fong, D. Y. (2007). Prevalence, course, and risk factors for antenatal anxiety and depression. Obstetrics & Gynecology, 110, 1102-1112. Leight, K. L., Fitelson, E. M., Weston, C. A., & Wisner, K. L. (2010). Childbirth and mental disorders. International Review of Psychiatry, 22, 453-471. Maa, S. H., Tsou, T. S., Wang, K.Y., Wang, C. H., Lin, H. C., & Huang, Y. H. (April 2007). Self-administered acupressure reduces the symptoms that limit daily activities in bronchiectasis patients: pilot study findings. Journal of Clinical Nursing, 16, 794-804. Martini, J., Knappe, S., Beesdo-Baum, K., Lieb, R., & Wittchen, H. U. (2010). Anxiety disorders before birth and self-perceived distress during pregnancy: Associations with maternal depression and obstetric, neonatal and early childhood disorder. Early Human Development, 86, 305-310. Mehdizadeh, J. (2002). A guideline for applying acupressure. Tehran, Iran: Noor Danesh. [In Persian] Ming, J. L., Kuo, B. I., Lin, J. G., & Lin, L. C. (2002). The efficacy of acupressure to prevent nausea and vomiting in post-operative patients. Journal of Advanced Nursing, 39, 343-351. Morrison, M. K., Lowe, J. M., & Collins, C. E. (2014). Australian women’s experiences of living with gestational diabetes. Women and Birth, 27, 52-57. Mulder, E. J. H., Medina, R., Huizink, A. C., Van den Bergh, B. R., Buitelaar, J. K., & Visser, G. H. (2002). Prenatal maternal stress: Effects on pregnancy and the (unborn) child. Early Human Development, 70, 3-14.
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Newham, J. J., Westwood, M., Aplin, J. D., & Wittkowski, A. (2012). State-trait anxiety inventory (STAI) scores during pregnancy following intervention with complementary therapies. Journal of Affective Disorders, 142, 22-23. Obel, C., Hedegaard, M., Henriksen, T. B., Secher, N. J., Olsen, J, & Levine, S. (2005). Stress and salivary cortisol during pregnancy. Psychoneuroendocrinology, 30, 647-656. Qiao, Y., Wang, J., Li, J, & Wang, J. (2012). Effects of depressive and anxiety symptoms during pregnancy on pregnant, obstetric, and neonatal outcomes: A followup study. Journal of Obstetrics & Gynaecology, 32, 237-240. Song, H. J. (2015). Effect of self-acupressure for symptom management: A systematic review. Complementary Therapies in Medicine, 23, 68-78. Spence, D. W., Kayumov, L., Chen, A., Lowe, A., Jain, U., Katzman, M. A., . . . Shapiro, C. M. (2004). Acupuncture increases nocturnal melatonin secretion and reduces insomnia and anxiety: A preliminary report. Journal of Neuropsychiatry and Clinical Neurosciences, 16, 19-28. Thiagayson, P., Krishnaswamy, G., Lim, M., Sung, S. C., Haley, C. L., Fung, D., . . . Chen, H. (2013). Depression and anxiety in Singaporean high-risk pregnancies: Prevalence and screening. General Hospital Psychiatry, 35, 112-116. Tiran, D., & Chummun, H. (2004). Complementary therapies to reduce physiological stress in pregnancy. Complementary Therapies in Nursing & Midwifery, 10, 162-167. Trief, P. M., Sandberg, J., Greenberg, R. P., Graff, K., Castronova, N., Yoon, M, & Weinstock, R. S. (2003). Describing support: A qualitative study of couples living with diabetes. Families. Systems & Health, 21, 57-67. Tsay, S. L., & Chen, M. L. (2003). Acupressure and quality of sleep in patients with end-stage renal disease: A randomized controlled trial. International Journal of Nursing Studies, 40, 1-7. Tutino, G., Tam, W., Yang, X., Chan, J., Lao, T, & Ma, C. (2014). Diabetes and pregnancy: Perspectives from Asia. BMC Pregnancy and Childbirth, 31, 302-318. Werntoft, E, & Dykes, A. K. (2001). Effect of acupressure on nausea and vomiting during pregnancy: A randomized, placebo-controlled, pilot study. Journal of Reproductive Medicine, 46, 835-839. Yogev, Y., Metzger, B. E., & Hod, M. (2009). Establishing diagnosis of gestational diabetes mellitus: Impact of the hyperglycemia and adverse pregnancy outcome study. Seminars in Fetal Neonatal Medicine, 14, 94-100.
Author Biography Farideh Bastani is a Professor of Nursing at Iran University of Medical Sciences (IUMS), Tehran, Iran. She received her B.Sc. degree in Nursing (1984) from IUMS, her M.Sc. in nursing (1998), and finally her Ph.D. in Health Education and Health Promotion (2005) from Tarbiat Modares University, Tehran, Iran. Dr. Bastani has spent 20 years teaching in the both fields of Nursing and Health Education/Health Promotion at IUMS as a faculty member of the Department of Maternal and Neonatal Health Nursing as well as the Department of Geriatric Nursing.
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CNRXXX10.1177/1054773815579344Clinical Nursing ResearchBastani
Article
Effect of Acupressure on Maternal Anxiety in Women With Gestational Diabetes Mellitus: A Randomized Clinical Trial
Clinical Nursing Research 1–17 © The Author(s) 2015 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1054773815579344 cnr.sagepub.com
Farideh Bastani, PhD, MSc, BSc1
Abstract Women with diabetes often experience a higher level of anxiety. The aim of the study was to evaluate the effect of acupressure on relieving anxiety of women with gestational diabetes mellitus (GDM). A randomized clinical trial was conducted on 60 women with GDM at a university hospital. The participants were allocated to an experimental and a placebo group (30 women per group). The experimental group received a nurse-provided acupressure at the true point, and the placebo group received pressure (touching) at a sham (false) point. Anxiety was measured immediately in the groups prior to and after a 2-day intervention by a questionnaire and the Visual Analogue Scale. The data were analyzed using descriptive and inferential statistics. Results indicated that the acupressure group had significantly lower anxiety than the placebo group (p ≤ .0001). In conclusion, the effects of acupressure appeared to be effective in reducing anxiety in diabetic pregnant women.
1Iran
University of Medical Sciences, Tehran, Iran
Corresponding Author: Farideh Bastani, School of Nursing & Midwifery, Department of Maternal–Neonatal Health Nursing and Department of Geriatric Nursing, Iran University of Medical Sciences, Tehran, Iran. E-mail: [email protected]
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Keywords acupressure, anxiety, diabetes, health, pregnancy
Introduction As pregnancy can be both an exciting and worrying time for mothers-to-be, they experience a range of physical and emotional changes, which may trigger stress and anxiety (Correia & Linhares, 2007; Field et al., 2010; Qiao, Wang, Li, & Wang, 2012). Anxiety in pregnancy is the most potent maternal risk factors for adverse pregnancy outcomes (Dunkel Schetter, 2010; Thiagayson et al., 2013). It has been reported that pregnant women with gestational diabetes mellitus (GDM) experience higher anxiety and stress levels than do non-pregnant women and healthy pregnant women (Hayase, Shimada, & Seki, 2014; Yogev, Metzger, & Hod, 2009). Despite the increases in attention to psychological state of pregnant women, pregnant women frequently do not receive prevention or treatment for anxiety and stress concerns (Flynn, Blow, & Marcus. 2006). Antidepressants and anxiolytics can harmfully affect the fetus and thus are not “safe” during pregnancy. They should be replaced by non-pharmacologic treatments whenever possible (Campagne, 2007). Acupressure, a treatment method in Chinese medicine, has been reported in randomized clinical trials (RCTs) and systematic reviews to be useful in alleviating the symptoms of various health problems including anxiety in a variety of patient populations (H. M. Chen, Chang, & Hsu, 2005; Etri & Adib-Hajbaghery, 2012; Song, 2015). However, studies about the effects of acupressure on relieving health problems in pregnant women with GDM are scarce. In summary, considering the limited studies to support the efficacy of acupressure for anxiety reduction during pregnancy in women with GDM, the purpose of this study was to evaluate the effects of acupressure in reducing pre-natal anxiety and its severity in women with GDM.
Background GDM is the most common medical complications of pregnancy characterized by glucose intolerance with onset or first recognition during pregnancy (American Diabetes Association [ADA], 2009) affecting up to 25% of pregnancies in Asia (Tutino et al., 2014). Although the precise cause of GDM is unknown, during pregnancy, the evidence suggests that human placental lactogen (HPL) has growth hormone–like actions, and that it causes lipolysis and thereby increases the levels of circulating fatty acids that inhibit the action of insulin and cause insulin resistance in pregnant women (Tutino et al., 2014).
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It is reported that the women with high-risk pregnancy, including GDM (as a predictor of anxiety), would appear to be at a greater risk of experiencing anxiety because of the physical and psychological demands of their complicated pregnancies (Broussard, 2007). In a study conducted by Hirst et al. (2012), it was revealed that women with GDM who participated in qualitative focus groups reported feelings of increased fear and anxiety, largely because of lack of information around the disorder and perceived high-risk pregnancy. In this regard, maternal anxiety associated with pregnancy has been examined in Australian women’s reflections on the experience of having a pregnancy affected by GDM (Morrison, Lowe, & Collins, 2014). It was reported that the women have been more likely to experience shock, fear, or anxiety. It is also well documented that anxiety among pregnant women is a risk factor for adverse maternal and child outcomes (Field et al., 2010; Leight, Fitelson, Weston, & Wisner, 2010; Martini, Knappe, Beesdo-Baum, Lieb, & Wittchen, 2010). In pregnancy, during experiencing anxiety (as a dimension of stress), various hormones, including adrenocorticotrophin-releasing hormone, cortisol, noradrenalin, and beta-endorphin, are released in large quantities in the blood. Increased beta-endorphin levels have been reported to be associated with decreased utero-placental blood flow, resulting in fetal hypoxia (Mulder et al., 2002). GDM is also claimed to be associated with anxiety and poor pregnancy outcomes including caesarean delivery, pre-eclampsia and preterm birth, neonatal hypoglycemia, fetal hyperinsulinemia, birth injury (predominantly shoulder dystocia), neonatal hyperbilirubinemia, and neonatal intensive care unit admission (Dunkel Schetter, 2010; Yogev et al., 2009) and adverse outcomes in glycemic control (Herzer & Hood, 2010). There may be a synergetic effect of gestational diabetes and anxiety, despite substantial evidence to the contrary. In a case control study of 160 pregnant women with diabetes, anxiety symptoms increased the risk of diabetes significantly (Hasan et al., 2013). Thus, the methods used to control anxiety and enhance relaxation and comfort could result in physiologic changes such as lowering metabolism, muscle tension, and enhancing immune function (Tiran & Chummun, 2004). Indeed, research on the methods to decrease maternal anxiety is scarce. One approach to manage anxiety is acupressure, which is a non-invasive variant of acupuncture that has been shown to be useful for multiple symptoms management including anxiety in a variety of patient populations (H. M. Chen et al., 2005). By implementing this low-cost nonpharmaceutical intervention, significant reduction in anxiety in women with GDM could be hypothesized. To the best of our knowledge, no similar research focusing on this topic has been conducted or published.
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Women screened for eligibility (n=106) Excluded (n= 46) Not meeting inclusion criteria (n=31) Declined to participate (n=15) Randomized (n=60)
Allocated to experimental group [received acupressure] (n=30)
Allocated to placebo group [received touch] (n=30)
Dropped out from analysis [diagnosed with thyroid disease during hospitalization after first assessment] (n=1), [Recent stressful events in their lives] (n=1)
Dropped out from analysis [Discontinued touch due to personal reasons] (n=1)
Analyzed (n=28)
Analyzed (n=29)
Figure 1. Consort flow diagram indicating patient screening, intervention allocation, and analysis. Note. n = number of patients.
Materials and Method Study Design and Setting A single blind RCT was used in the study. The participating women were blinded in a way they did not know in which treatment option (acupressure or placebo) they were. The RCT was conducted at a large university hospital in Tehran, Iran. The flowchart of the patients passed through the trial is presented in Figure 1.
Participants One hundred six hospitalized women with newly diagnosed insulin-dependent GDM were screened to satisfy the selection criteria for participating them in the study. The reasons for the hospitalization (routinely 3 to 5 days) of the pregnant women were the close monitoring of the expectant mothers for insulin injection training, glycemic control, and fetal health assessment. Forty-six patients were excluded from the screening from which 31 did not meet the inclusion criteria, and the rest (n = 15) declined to participate. Sixty eligible
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women, who were matched by considering the specific potential confounders of age and familial history of diabetes, were recruited with a 20% sample loss. The power, effect size, and alpha were set at 0.80, 0.20, and .05, respectively, with the effect size of nearly 1. Equal study groups (experimental and placebo), each including 30 patients, were created by a block randomization. Of the total participating women (60), 3 participants (2 participants of the experimental and 1 participant of the placebo groups) were dropped out from the study and failed to complete the trial for data analysis. The inclusion criteria were (a) expressing anxiety (in the context of hospitalization of the women who were asked to express their feelings before their inclusion to the study), (b) singleton pregnancy, (c) young females (18-40 years), (d) gestational age between 20 and 42 weeks, (e) not smoking, and (f) not taking oral sedatives. The dropout reasons of the participants (n = 2) in the experimental group were (a) bad obstetric situations (newly diagnosed with thyroid disease), after the first assessment, during hospitalization and the trial (n = 1), and (b) a recent stressful event (n = 1). The reason of dropout in the placebo group was refusing the touch by the patient due to personal reasons (n = 1). The main exposure of the experimental group was acupressure, at the true point (P7), and the intervention of the placebo group was pressure (touching) at a sham (false) point by a certified nurse who had attended in an acupressure training course.
Procedure The study procedure was approved by the ethics committee of the university hospital in accordance with the ethical standards laid down in the 1995 Declaration of Helsinki. Written informed consent was obtained from the participants prior to their inclusion in the study. The participating women were also given verbal information before taking their informed consent. The primary outcomes were maternal anxiety and its severity, which were measured immediately in the groups prior to and after the completion of the interventions (during 3 days) to test the effectiveness of the nurse-provided acupressure on the anxiety of the women with GDM between August 2011 and October 2012. As mentioned earlier, there is a routine hospitalization of the women with GDM in university hospitals in Iran lasting for a period of 3 to 5 days for training them for insulin injection, close monitoring of the expectant mothers for glycemic control, and fetal health assessment. Thus, we had better access to the women over such period, and our acupressure treatment was limited to 3 days of the women’s hospitalization. Actually, we expected the women in the experimental group to learn and continue to apply the acupressure (if effective) for self-management of their anxiety at home.
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The women were randomized to two experimental (acupressure) and control (touch) groups by blocking randomization.
Interventions Both of the acupressure at the true point (for the experimental group) and touching at a false point (for the placebo group) were delivered by the same certified nurse simultaneously with a 30-min interval. Allocation concealment of the participants in the acupressure was applied. However, contamination of acupressure intervention among women in the placebo group might have been occurred, because acupressure was performed on the experimental group while the other patients (in the placebo group) were hospitalized at the same ward and underwent monitoring and treatment. In other words, there was a possibility that the patients allocated in the placebo group might have learnt to perform their own acupressure. However, that would not be comparable with the acupressure performed by the certified nurse, which was consistently applied according to the standardized protocol. The acupressure is a massage technique using fingers and palms with a certain amount of force to stimulate true acupoints and meridian lines (similar to the vascular system for the circulation of blood) on the surface of the skin. The acupoint Pericardium 7 (P7) was selected to receive the acupressure, because this acupoint is easily accessible, and if made effectively and necessarily, the acupressure at this point can then be learned and performed by the patient herself (Maa et al., 2007). Using this particular acupoint ensures that patients feel neither uncomfortable nor that their privacy is compromised. The experimental group received 3 days’ acupressure treatments on their forearms bilaterally within 2 days. The acupressure force was validated by applying the thumb pressure on a 3- to 5-kg scale, calibrated to national standards. For each pressure on each side, P7 pressure was continuously applied by the nurse’s thumb for a period of 3 min for each of the women’s wrist. This process was repeated 3 times a day to bring the total treatment time to 9 min for each forearm and 18 min for both sides per day according to a protocol reported by Maa et al. (2007) and Mehdizadeh (2002). Before performing the acupressure, the nurse used a scale to assess the degree of pressure applied by requesting her colleagues to observe the pressure for 10 s. This was done to ensure that the pressure was maintained within a 3- to 5-kg range until the patient reported a gentle tingling and numbness sensation. Those assigned to the placebo or sham group received the touching with the same frequency and duration of the acupressure group within the same days at a site on the wrong point, which was selected at 0.5 cm away from the true acupressure point (dorsal part of the left and right forearms) that is
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thought to be ineffective and has been used in other placebo controlled trials (Heazell et al., 2006; Werntoft & Dykes, 2001).
Assessment Instruments At pre-intervention, data were collected from both of the groups by using three different measurement tools. These included the Demographic and Clinical Questionnaire (DCQ), the Maternal Anxiety Questionnaire (MAQ), and a Visual Analogue Scale for the Severity of Anxiety (VASA).The Cronbach’s coefficient alpha was used to assess the internal consistency. The DCQ provides data corresponding to the maternal age, education level, employment status, economic status, parity, history of abortion, history of familial diabetes, and the plan of pregnancy. Comparisons were made between the maternal anxiety scores and the severity of anxiety 2 times before the first intervention and immediately after the last intervention of the hospitalized women with GDM (on third day) in the experimental and placebo groups. Maternal anxiety was measured using the MAQ (Ahadi, 2009) consisting of 15 statements describing various emotional states. The statements of the MAQ are scored on a 4-point Likert-type scale from “not at all” to “very much so” (with the scores of 1 to 4, respectively). The score from each item is then summed to give a total score ranging from 1 to 50. Higher scores indicate more anxiety in the women. Content and face validity of the MAQ were assessed by a group of scholars and experts to detect any unclear and misleading questions. When tested for this study, the MAQ revealed appropriate internal consistency (Cronbach’s α = .83). The VASA consists of a 10-cm horizontal scale with the descriptors of “no anxiety” written on the left and “worst possible anxiety” written on the right of the scale. Participants were asked to place a mark on the 10-cm rated line, at a point corresponding to the level of the anxiety intensity (severity) they felt at the time of enquiry. The VASA has been reported to be sensitive to pharmacologic and nonpharmacologic procedures that alter the experience of anxiety with favorable validity and reliability (Chang, Wang, & Chen, 2002). Visual Analogue Scale is a valid test for anxiety. It can be used alone or in combination with other measures to improve the assessment of anxiety. The patients with a VASA > 5.0 cm should be regarded as anxious. The VASA was administered pre-operatively by Facco et al. (2011) to 1,114 patients. The study confirmed that VASA is a simple, sensitive, fast, and reliable tool, and can be used effectively in the assessment of anxiety using the value of 5.1 as cutoff point.
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Data Analysis The collected data were processed using the SPSS for Windows, Version 15.0. The data were entered twice in the SPSS data file. The data were expressed as the numbers, n (%), or means accompanied with standard deviations, M (SD), as appropriate. The results were analyzed by the chi-square (or Fisher’s exact) test and t test. This study was designed to detect betweengroup and within-group differences. The chi-square test was used for the comparison of the experimental and placebo groups. Regarding the primary outcome measures (anxiety and its severity), the differences between the preand post-intervention scores were compared using the independent t test considered to be significant with p ≤ .05. The one-tailed paired t test was applied to estimate the pre–post intervention differences within the groups. All the variables displayed a normal distribution based on the Kolmogorov–Smirnov test.
Results In the study, two enrolled patients of experimental group and one patient of placebo group did not complete the study. Therefore, the patients were considered dropouts for technical or medical reasons. The analysis was thus based on 28 participants in the experimental group and 29 in the placebo group during the study. The two groups did not differ significantly regarding demographic and clinical variables (Table 1). All women in the study were married and in their second half of pregnancy. The average ages of the participants were 29.9 (SD = 6.41) years and 29.77 (SD = 6.55) years in the experimental and placebo groups, respectively. Tables 2 and 3 present the means and standard deviations on the scores of pre- and post-intervention of primary outcome measures. There were no significant differences between the groups regarding the mean scores of anxiety and its severity before intervention, ps = .65 and .84, respectively (Tables 2 and 3). Whereas, at postintervention, women participating in the acupressure group showed statistically significant decreases in anxiety (p ≥ .05) and its severity (p = .006) compared with the placebo group (Tables 2 and 3). In terms of the primary outcome measures (anxiety and its severity), in the acupressure group, there were significant decreases between the pre- and post-intervention mean scores in the anxiety on the MAQ and its severity on the VASA (p = .001) with the change difference of 3.96 points and 3.47 points, respectively. Although it should be noted that the mean score of anxiety on the MAQ remained unchanged (with the change difference of 0) in the placebo group, the reduction of the severity of anxiety on the VASA was
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Acupressure group n (%; N = 30)
Age (year) 40 1 (3.8) Education High school 16 (55.2) Diploma 8 (27.6) University 5 (17.2) Employment Employed 3 (10.3) Unemployed 26 (89.7) Economic status Good 1 (3.4) Moderate 24 (82.8) Bad 4 (13.8) Gestational age (week) 20-24 2 (69) 24-39 3 (10.3) 30-34 12 (41.4) ≥35 12 (41.4) History of familial diabetes Yes 8 (27.6) No 21 (72.4) Experience of spontaneous abortion Yes 9 (31) No 20 (69) Plan of pregnancy Planned 26 (89.7) Unplanned 3 (10.3)) Parity Primipara 12 (41.1) Multipara 17 (58.6)
Placebo group n (%; N = 30)
p value (Fisher’s exact test)
3 (10) 16 (53.3) 10 (33.3) 1 (3.3)
*(p = .07)
16 (53.3) 13 (43.3) 1 (3.3)
*(p = .15)
1 (3.3) 29 (96.7)
*(p = .35)
1 (3.3) 21 (70) 8 (26.7)
*(p = .59)
3 (10) 7 (23.3) 10 (33.3) 10 (33.3)
*(p = .27)
11 (36.7) 19 (63.3)
*(p = .45)
9 (30) 21 (70)
*(p = .93)
23 (76.7) 7 (23.3)
*(p = .29)
11 (36.7) 19 (63.3)
*(p = .71)
*Not statistically significant.
found significant (with the change difference of 2 points). In this study, a level of significance was selected (α = .05), which means there is only a 5% probability that the difference between the groups is due to chance. In this
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Table 2. Women’s Anxiety Level by Group at Pre–Post Intervention. Pre-intervention
Variable
Acupressure group
Placebo group
Acupressure group
Placebo group
n (%)
n (%)
n (%)
n (%)
Anxiety score (MAQ) Low (20-30) Moderate (31-40) High (41-50) Very high (>50) Total M ± SD t test
Post-intervention
4 (14.3) 5 (17.2) 13 (46.4) 15 (51.7) 11 (39.3) 7 (24.1) 0 (0) 2 (6.9) 28 (100) 29 (100) 37.35 ± 5.88 36.51 ± 7.84 *p = .65, df = 55, t = 0.45
7 (25) 5 (17.2) 19 (67.9) 14 (48.3) 2 (7.1) 8 (27.6) 0 (0) 2 (6.9) 28 (100) 29 (100) 33.3 ± 4.289 36.51 ± 7.28 **p = .05, df = 55, t = −1.96
Note. MAQ = Maternal Anxiety Questionnaire. *Not statistically significant. **Statistically significant.
Table 3. Severity of Anxiety Between Acupressure and Placebo Groups at Pre–Post Intervention. Pre-intervention
Variable Severity of anxiety (VASA) Not at all anxious (0) Mildly anxious (1-3) Moderately anxious (4-6) Severely anxious (7-9) Extremely anxious (10) Total M ± SD t test Change difference (anxiety) Change difference (severity of anxiety)
Acupressure group
Placebo group
n (%)
n (%)
Post-intervention Acupressure Placebo group group n (%)
n (%)
0 (0) 0 (0) 1 (3.6) 0 (0) 3 (10.7) 5 (17.2) 17 (60.7) 13 (44.8) 11 (39.3) 10 (34.5) 9 (32.1) 12 (41.4) 12 (42.9) 12 (41.4) 1 (3.6) 3 (10.3) 2 (7.1) 2 (6.9) 0 (0) 1 (3.4) 28 (100) 29 (100) 28 (100) 29 (100) 6.43 ± 2.16 6.31 ± 2.39 2.96 ± 1.55 4.31 ± 2.00 *p = .84, df = 55, **p = .006, df = 55, t = 0.195 t = −2.83 Acupressure group: 3.96 Placebo group: 0.0 Acupressure group: 3.47
Placebo group: 2.0
Note. VASA = Visual Analogue Scale for the Severity of Anxiety. *Not statistically significant. **Statistically significant.
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case, regarding the “clinical significance” about the importance of the finding, we used effect size. The effect size in the study was calculated, and it was approximately equal to 1, which is a type of practical significance.
Discussion The results suggest that acupressure during pregnancy resulted in a significantly greater decline in primary outcome measures (anxiety and its severity) in the experimental group compared with the placebo group at post-intervention assessment. All of the participants (women with GDM) were hospitalized in a pre-natal ward (as high-risk obstetrical ward) at a university hospital. The high-risk obstetrical patients who are hospitalized in maternity wards may commonly experience anxiety and stress (Byatt et al., 2014) which could be associated with altered physiological parameters regarding the release of glucocorticoids such as cortisol, releases the catecholamines, norepinephrine, and epinephrine (Obel et al., 2005). Therefore, the women with high-risk pregnancies including GDM may be at increased risk of mood disorders (Thiagayson et al., 2013). In other words, diagnosis of GDM could be considered a source of anxiety (Hjelm, Berntorp, Frid, Aberg, & Apelqvist, 2008); however, the relationship between anxiety and GDM and whether they are synergistic effects between them has not been extensively studied. In this study, there were no significant differences regarding demographic variables in the experimental and placebo groups. At pre-intervention, a large percentage of the anxious women were in their third trimester in the acupressure and placebo groups. This might be because of the higher level of the anxiety in the third trimester compared with the second trimester (A. M. Lee et al., 2007). Most of the participants were multipara, which could be a risk factor for the anxiety in pregnancy, as the women may be unable to function day to day (DiPietro, Sipsma, & Costigan, 2008). However, the presence of anxiety in the primipara women may be due to their adaptation to the challenge of becoming first-time parent. With regard to the primary outcome measures, there were no significant differences of anxiety and its severity between the groups before intervention. Whereas, at post-intervention, women participating in the acupressure group showed statistically significant decreases in anxiety and its severity compared with the placebo group. The results are congruent with the studies carried out by Agarwal et al. (2005) and H. M. Chen et al. (2005) in relation to the effectiveness of acupressure in decreasing patients’ anxiety. Whereas an opposite result has also been reported in another study (Ming, Kuo, Lin, & Lin, 2002) in which it is reported that acupressure is not able to successfully relieve anxiety. In terms of the primary outcome measures, the scores of the
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change difference of anxiety at pre- and post-intervention on the MAQ and the VASA were 3.96 and 3.47, respectively, in the acupressure group. Although it should be noted that the change difference of anxiety on the MAQ remained unchanged (0) in the placebo group and the change difference of the severity of anxiety on the VASA that reported on the 10 cm rated line on the Visual Analogue Scale was 2. Notably, when comparing the groups, this unexpected change difference (2) on the VASA in the placebo group was not greater than the change difference score (3.47) on the VASA in the experimental group. It seems that the women of both the groups were more likely to be motivated to use a technique to manage their anxiety. A study with the RCT design of the acupressure in individuals with anxiety has found an improvement noted in both of the placebo and acupressure groups (H. M. Chen et al., 2005). In this study, the sham placebo point was selected at 0.5 cm away from the true acupressure point; it seems that there might have been small beneficial effects of the intervention (touch) on the placebo group. This is consistent with the studies carried out by Chen (1996), and Tsay and Chen (2003) who found symptoms improvement (including anxiety) of acupressure on the sham point of their placebo group. Another explanation is that all of the participants were married in the study and may have been supported by their spouses, although not measured in this study. This may have assisted the anxious women to have a great motivation for problem solving and self-care management regarding their anxiety (Trief et al., 2003). It could also be concluded that being touched might play an important role in governing emotional well-being and comfort experience. In human beings, the skin contains receptors. Hence, when an individual’s skin is stimulated, for example, by touch or massage, endorphin levels are increased, which elicit a relaxation effect (Field et al., 2010). In other words, being supported and cared with touching in the placebo group may have allowed the women to feel in control and relaxed that could result in reducing anxiety (Ip, 1999). The intervention in the placebo (touch) has not been as effective as that of the acupressure group to decrease anxiety and the severity of anxiety. Applying acupressure in the women with GDM significantly reduced the severity of anxiety on the VASA with considerable change differences with a value of 5.1 as the cutoff point that could be considered clinically important. In addition, acupressure as an alternative therapy during hospitalization may also be associated with other clinical benefits such as the improved well-being and comfort of the women. This result is consistent with the conclusion of a systematic review related to 10 eligible studies assessing interventions with complementary and alternative therapy (CAT), including acupressure designed to reduce anxiety (Newham, Westwood, Aplin, & Wittkowski, 2012). They found that those in
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the intervention group were more likely to show a significant reduction in the post-intervention anxiety scores. Acupressure as a CAT, by stimulation of acupoints, may increase a release of serotonin and melatonin, which relaxes the body and consequently reduces the anxiety (Spence et al., 2004). It should also be noted that acupressure was popular with our participants, all of whom were grateful and looked forward to their next treatments. They particularly enjoyed the opportunity to discuss their feelings with the nurse and to have their symptoms recognized and accepted by health professionals. Because acupressure is a low-cost and easy technique for relaxation, it appears to be especially agreeable to participants; it is likely that this will enhance compliance in pregnant women in a long-term anxiety management. Thus, a longitudinal study is recommended to investigate the long-term effects of acupressure on anxiety in the women with GDM. Seemingly, anxiety could be significantly decreased during self-administered or professionally provided acupressure (Honda, Tsuda, Horiuchi, & Aoki, 2013). A survey of the literature has suggested that a single session of acupressure, provided by professionals, reduces anxiety (Agarwal et al., 2005; Honda et al., 2013). This study is unique as the results revealed that acupressure at true points (P7) can significantly reduce anxiety in hospitalized women with GDM, compared with a placebo group. Acupressure techniques can be easily learnt by patients so that they can manage relaxation themselves (Guerreiro da Silva, Nakamura, Cordeiro, & Kulay, 2005). In pregnant women with diabetes who tend to feel vulnerable to anxiety, it is important to establish a caring relationship and applying a technique to be empowered to manage their anxiety in a way to strive from normoglycemia and to reconcile with the disease (Berg, 2005). Therefore, our study could add support to the notion that the effect of acupressure on anxiety may be clinically worthwhile; because the costs and risks of acupressure are low, they can be considered for clinical use. Furthermore, the randomized controlled design was one of the strengths of this study. As there were no differences in women characteristics between the experimental group and the placebo group, the possible differences in the primary outcome measures could be ascribed to the intervention with more certainty. There have also been some limitations in this study that should be noted. We have to consider that the voluntary nature of the participation in the study may have led to a selection bias, in the sense that those women who agreed to participate, and also those who complied with the evaluations, may in fact be those who feel more involved in the study. This study conveniently selected the sample of only married women with GDM, focused on the self-report questionnaire for assessing subjective aspect of the anxiety in a short time of 3 days. Therefore, our study has limited generalizability due to marital status
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and reliance on the self-report measures. Moreover, if possible, the evaluation of the objective symptoms of anxiety with more prolonged period of acupressure could lead to more conclusive results, whereas only subjective anxiety and its severity were assessed in this study. Hence, future studies can be suggested to evaluate other outcomes such as glycemic control and pregnancy outcomes in women with GDM who receive acupressure. In conclusion, this study provides preliminary evidences on the effectiveness of short-term acupressure in reducing anxiety and its severity in hospitalized pregnant women with GDM.
Implications for Nursing Practice Nursing personnel as health care providers represent the largest component of the health care workforce in hospitals. They have a responsibility to help patients relieve their anxiety. They should be equipped, adopt evidence-based practices, and translate them into clinical settings. Despite the limitations of this study, it showed that the nurse-provided acupressure is an effective method to reduce anxiety in hospitalized women with GDM in short term. This has considerable implications for nursing practice, as acupressure is a low-cost and easy-to-learn technique that can be incorporated in the care planning of women with GDM. Declaration of Conflicting Interests The author declares no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author received no financial support for authorship, and/or publication of this article.
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Author Biography Farideh Bastani is a Professor of Nursing at Iran University of Medical Sciences (IUMS), Tehran, Iran. She received her B.Sc. degree in Nursing (1984) from IUMS, her M.Sc. in nursing (1998), and finally her Ph.D. in Health Education and Health Promotion (2005) from Tarbiat Modares University, Tehran, Iran. Dr. Bastani has spent 20 years teaching in the both fields of Nursing and Health Education/Health Promotion at IUMS as a faculty member of the Department of Maternal and Neonatal Health Nursing as well as the Department of Geriatric Nursing.
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