RESEARCH doi: 10.1111/nicc.12017
Touch massage: a pilot study of a complex intervention ¨ Marcus Karlsson, Urban Wiklund Lenita Lindgren, Stefan Lehtipalo, Ola Winso, and Christine Brulin ABSTRACT Objectives: To report and evaluate a complex touch massage intervention according to the British Medical Research Council framework. This study aimed to evaluate the effects of touch massage on levels of anxiety and physiological stress in patients scheduled for elective aortic surgery. Background: The use of touch massage has increased during the past decade but no systematic studies have been implemented to investigate the effectiveness of such treatment. It is important to conduct multidisciplinary investigations into the effects of complex interventions such as touch massage. For this, the British Medical Research Council has provided a useful framework to guide the development, piloting, evaluation and reporting of complex intervention studies. Method: A pilot study with a randomized controlled design including 20 patients (10 + 10) scheduled for elective aortic surgery. Selected outcome parameters included; self-reported anxiety, measured by the State-Trait Anxiety Inventory Form Y instrument, and physiological stress, measured by heart rate variability, blood pressure, respiratory frequency, oxygen saturation and concentrations of cortisol, insulin and glucose in serum. Results: There were significant differences in self-reported anxiety levels before and after touch massage (p = 0·007), this was not observed in the control group (p = 0·833). There was a significant difference in self-reported anxiety levels between the touch massage group and the control group after touch massage and rest (p = 0·001). There were no significant differences in physiological stress-related outcome parameters between patients who received touch massage and controls. Conclusion: In our study, touch massage decreased anxiety levels in patients scheduled for elective aortic surgery, and the British Medical Research Council framework was a useful guideline for the development, evaluation and reporting of a touch massage intervention. Relevance to clinical practice: Touch massage can reduce patients’ anxiety levels and is thus an important nursing intervention in intensive and post-operative care. Key words: Adult intensive care • Care nursing • Clinical research • Complex interventions • Intensive • Psychological care of patients • Research
BACKGROUND Patients cared for in intensive care units sometimes show strong responses to touch massage (TM) including decreased heart rate, blood pressure and
Authors: L Lindgren, RN, MSn, PhD, Department of Nursing, Umea˚ University and Department of Surgical and Perioperative Science ˚ Sweden; S Lehtipalo, MD, Chief Anesthesiology and Intensive Care, Umea, Physician, Department of Surgical and Perioperative Science Anesthesiology ˚ Sweden; O Winso, ¨ Professor, and Intensive Care, Umea˚ University, Umea, Chief Physician, Department of Surgical and Perioperative Science ˚ Sweden; Anesthesiology and Intensive Care, Umea˚ University, Umea, M Karlsson, Research Engineer, Master of Science, Department of ˚ Sweden; U Wiklund, Biomedical Engineering, Umea˚ University, Umea, associate Professor, Research Engineer, Department of Biomedical ˚ Sweden; C Brulin, Professor, RN, Engineering Umea˚ University, Umea, ˚ Sweden MSn, Department of Nursing, Umea˚ University, Umea, Address for correspondence: L Lindgren, Department of Nursing, ˚ Sweden Umea˚ University, SE-901 87 Umea, E-mail: [email protected]
respiratory frequency. Patients have also reported less anxiety, pain and stress after TM. From these observations we hypothesized that TM influences both physical and emotional outcome parameters. To test this hypothesis we evaluated TM in patients scheduled for elective aortic surgery and thereafter cared for in an intensive care unit. A challenge in health care is the evaluation of nursing interventions such as TM in order to develop and improve nursing care. Generally, these interventions are time-consuming and complex, with several confounders to be taken into account. The British Medical Research Council (MRC) framework provides a systematic guideline containing methodological aspects for the development and evaluation of complex interventions. The four key elements of the development and evaluation process in the MRC framework are described as development, feasibility/piloting, evaluation and implementation (Craig et al., 2008). In this
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paper we use the developing, piloting and evaluation phases to describe and reflect upon methodological problems such as complexity and selected outcomes when evaluating TM in clinical praxis. Furthermore, we make recommendations to improve similar intervention studies in the future. The phase of the MRC framework, covering long-term implementation, is not addressed in this paper.
Developing a complex intervention One important issue is the practical and clinical effectiveness of an intervention (Haynes, 1999). When our project began by observing responses to TM in patients in a clinical setting, the practical effectiveness and use of the intervention were apparent. According to MRC, identifying the research question and the existing evidence base is essential in the first stage (van Meijel et al., 2004; Craig et al., 2008). Massage studies have been evaluated and presented in reviews (Ernst, 2009; Harris and Richards, 2010; Moraska et al., 2010) and most of which call for larger randomized controlled trials. The studies reported different results in some outcome parameters. It is important to take into account that massage techniques using different amounts of force and velocity activate different receptors and fibres. Therefore, it is difficult to compare study results from deep massage involving both skin and muscles with lighter massage only involving skin. For this reason, a custom-made device was constructed for this project to measure the force (2·5 N) and velocity (1–5 cm/s) applied during TM (Lindgren et al., 2012). We use the term ‘touch massage’ to describe gentle, soft, light, tactile massage that probably involves only the skin (Lindgren et al., 2010). Billhult et al. (2009) evaluated the effects of light massage (0·0090 kg/cm2 pressure) on physiological outcome parameters, and concluded that light massage may have short-term effects on systolic blood pressure (SBP) and heart rate. Other studies of massage described as ‘light’, ‘tactile’, ‘soft’, or ‘gentle’ reported altered emotions after massage treatments (Andersson et al., 2009; Cronfalk et al., 2009; Henricson et al., 2009). The next step after evaluating existing evidence about the intervention was to identify or develop theories about how the intervention works. There is a dearth of relevant physiological models explaining the observed responses to massages interventions; however, one theory suggests that activation of pressure receptors in the skin activates the parasympathetic nervous system (Field et al., 2010). Another theory posits that massage releases oxytocin, a hormone suggested to be involved in positive social experiences (Uvn¨as-Moberg, 1998). Evidence of how massage and pleasant human touch activate the human brain, 270
however, is sparse (Lindgren et al., 2012). Recently it has been suggested that nursing research needs to add both experimental and translational research to more descriptive and introspective studies (Richards and Borglin, 2011). We therefore performed two studies in healthy volunteers to develop a theoretical base. In our first study the aim was to evaluate the effects of TM on stress reactions using heart rate variability (HRV) to measure alterations in autonomic nervous system activity. The results showed that TM was associated with decreased activity in the sympathetic nervous system activity along with a compensatory decrease in the parasympathetic nervous system (Lindgren et al., 2010). In the second study we evaluated brain responses during TM using functional magnetic resonance imaging. The results revealed that TM activated a brain region, the pregenual anterior cingulated cortex (Lindgren et al., 2012), containing a high density of opioid receptors (Vogt, 2005). The pregenual anterior cingulated cortex is activated during happiness and pleasure (Vogt, 2005; Rolls, 2010), and induced activity in this brain region may reduce the effects of negative stimuli (Etkin et al., 2006). Consistent with our findings, a review of massage outcome parameters stated that the most pronounced effects of massage were decreased anxiety and decreased depression (Moyer et al., 2004). Thus, our findings indicate that TM has effect on emotions by activating specific brain areas, which as a consequence may alter the activity of the autonomic nervous system.
Assessing feasibility and piloting methods To test feasibility, practicability and acceptability according to the MRC second stage (Craig et al., 2008), we used our first study in healthy volunteers (Lindgren et al., 2010) to evaluate appropriate outcome parameters and adjust the intervention for the current study evaluating TM in a group of patients. From the study in healthy volunteers, a number of outcome parameters such as extracellular levels of glucose, lactate, glycerol and pyruvate measured by microdialysis were eliminated from further consideration. The TM intervention was also found to be adaptable to use on additional body parts (hands, feet, legs and arms), and based on HRV results, the massage time could be shortened from 120 to 60 min (Lindgren et al., 2010).
Evaluating and reporting a complex intervention As an example of how to report and evaluate a complex intervention, we will describe and discuss the results of a pilot study on the effects of TM in patients scheduled for elective aortic surgery. The aim of the pilot study was to evaluate anxiety levels and
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Touch massage: a pilot study of a complex intervention
stress-related outcome parameters in patients scheduled for elective aortic surgery. The selected outcomes were self-reported anxiety, HRV, blood pressure, respiratory frequency, oxygen saturation and concentrations of cortisol, insulin and glucose in serum. In the last part of the paper we will make recommendations to improve future similar intervention studies.
METHODS After approval from the Regional Ethical Review Board at Ume˚a University Hospital (Dnr 07-183M), patients scheduled for elective aortic surgery between October 2009 and June 2011 at Ume˚a University Hospital were invited to participate in this study. Of 32 individuals invited, 27 agreed to participate. Seven of the participants were excluded because of post-operative complications. Twenty patients cared for in intensive care settings (mean age = 65·9 years, SD = 5·1) were block randomized to either a control (n = 10) or an intervention (n = 10) group. The block randomization employed opaque envelopes with assigned treatment group per participant. All participants had cardiovascular disease and antihypertensive medication. Overall, the participants did not differ between groups in diseases or medications. Pre-operative values are shown in Table 1.
Intervention Participants in the intervention group received one TM intervention performed on the hands, arms, feet and legs for 60 min. TM was performed with a pressure of about 2·5 N and a velocity of 1–5 cm/s (Lindgren et al., 2012) with long stroking movements. Around knees, ankles, toes, elbows, wrists and fingers circular movements were applied. Neutral oil was used to avoid stick-and-slip-movements of the skin. Pressure and velocity were measured by a
custom-made device (Lindgren et al., 2012) The study took place in an intensive care unit in northern Sweden, and the intervention was performed by four specially trained and massage-educated staff members, including one of the authors (L. L.), who performed TM on 4 of the 10 occasions. The control group rested in the same setting in the presence of health professionals. The staff was instructed not to talk to the patients during TM intervention and control supervised rest. The milieu and monitoring in the intensive care unit remained as usual.
Measurements and analyses The Swedish version of State-Trait Anxiety Inventory Form Y (STAI-Y) instrument was used to assess selfreported anxiety levels. The STAY-Y was developed to measure state-anxiety as a temporary condition of anxiety and trait-anxiety as a long-term condition. The instrument has good construct validity, internal consistency, and test-retest validity (Spielberger, 1972; Spielberger et al., 1983). In this study STAY-Y was used to evaluate immediate changes in state-anxiety. The 20 items were summed for a total score ranging from 20 to 80, with higher scores reflecting higher levels of anxiety. Activity in the autonomic nervous system (both sympathetic and parasympathetic) before, during and after TM was measured through analysis of HRV (beatto-beat fluctuations in heart rate (Lindgren et al., 2010). Non-invasive blood pressure measurements during and after TM/control were recorded using a blood pressure cuff (Dura-cuff ref 2203 connected to Marquette Solar 8000M monitor, GE Healthcare, Milwaukee, WI, USA). Changes in respiratory frequency were recorded with an electrocardiogram and oxygen saturation measured on a saturation probe (Nellcor) placed on a digit and further transferred to Marquette Solar 8000 M monitor (GE Healthcare). Data were
Table 1 Background characteristic and values before surgery in respective group for all participants (10 + 10) presented in mean and standard deviation. Differences between groups are presented as p value
Age Days after surgery SBP (mmhg) DBP (mmhg) Oxygen saturation (%) Fasting glucose/s (mmol) Fasting insulin/s (mIU/L) Fasting cortisol/s (nmol/L)
TM group m (SD)
Control group m (SD)
p value
63·3 (5·3) 1·9 (0·7) 141·08 (23·05) 75·06 (11·05) 96·05 (1·05) 6·06 (2·05) 86·00 (75·06) 500·09 (214·07)
69·6 (3·4) 2·0 (1·4) 152·5 (22·6) 89·8 (7·01) 97·08 (1·07) 7·07 (2·09) 77·00 (86·00) 525·02 (138·01)
0·021 0·627 0·481 0·008 0·067 0·449 0·962 0·594
Days after surgery, how many days from surgery until the participants were circulatory, respiratory and neurological stable; SBP, systolic blood pressure; DBP, diastolic blood pressure.
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sampled directly from the monitor to a software computer system (Picic, Critical Care Manager, care suite 8.2, Wakefield, UK) and later extracted. For evaluation of hypothalamic-pituitary-adrenal activity and glucose metabolism, measurements of cortisol, glucose and insulin in serum were performed. Pre-operative blood samples were taken from a venous catheter (18 G 32 mm Smiths Medical, Milano, Italy). Post-operative blood samples were taken from an arterial catheter (20 G/1·0·10 mm × 45 mm, Becton Dickinson, Singapore). Serum cortisol levels were analysed in clinical routine in an accredited laboratory by Roche reagents on Cobas 6000/8000 analysers. Glucose in serum was analysed using Ortho Vitros GLU slides on a Vitros 5.1 FS analyser. Insulin in serum was analysed using Roche Elecsys Insulin reagents on a Modular E170 analyser. All analyses were conducted in the Clinical Chemical Laboratory at the University Hospital, Ume˚a, Sweden.
groups. Following Bonferroni correction, α level was set at p < 0·01 (Pallant, 2005). When data (interval data) were repeatedly measured, a parametric, mixed between–within subjects analysis of variance was conducted (blood pressure, respiratory frequency, oxygen saturation, HRV, cortisol, insulin and glucose) (Tabachnick and Fidell, 2007). Skewed data was log-transformed and tested for normality. All data are presented as mean (m) and standard deviation (SD) before log-transformation. Owing to the sensitivity of the mixed between–within subjects analysis of variance test and the recommendation by Pallant (2005), a more conservative α level of p < 0·001 was set for this test. The statistical analyses were performed with SPSS software (version 18.0, SPSS Inc., Chicago, IL, USA).
Procedure
As the focus of this paper was to link the MRC theoretical framework (Craig et al., 2008) with experiences of a clinical intervention study, the results and discussion are presented together, followed by a section reflecting upon the results/discussion. Participants’ baseline characteristics and pre-operative physiological variables are summarized in Table 1. Mean value and SD for all outcome parameters are presented in Table 2.
In the morning, the day before surgery, baseline blood pressure, heart rate and oxygen saturation were recorded and blood samples (cortisol, insulin and glucose) were collected. At 8·00 a.m., the day after surgery, neurological, respiratory and circulatory parameters were evaluated and blood samples (cortisol, insulin and glucose) were collected again. If the patients circulatory, respiratory or neurological systems were unstable, the assessments were performed every morning at 8·00 a.m. until they were stable. After reaching circulatory, respiratory and neurological stability patients were randomized to either the control or the intervention group. The intervention or control procedure took place between 12.30 a.m. and 1.30 p.m. on the day of randomization. Immediately before and after the intervention/control a set of data was collected including self-reported anxiety level and the outcome parameters described above. Later that evening (at 7·00 p.m.) and the following morning (at 8·00 a.m.) additional blood samples (cortisol, insulin and glucose) were collected. Because of normal diurnal changes in hormone levels, the samples were collected at the same time of the day. Fluids and medications given prior to and in conjunction with interventions were documented. All patients received a routine pre-operative epidural catheter with continuous analgesic infusion for post-operative analgesia.
Statistics When testing for differences in STAI score (ordinal data) non-parametric tests were used. Wilcoxon rank test was used to test for differences within groups (before and after intervention/control) and Mann-Whitney U test was used for testing between 272
RESULTS
STAI-Y There was a significant decrease in the total STAIY score in the intervention group after 60 min TM, z = −2.71, p = 0·007, with a large effect size (r = 0·60), but no such decrease was found in the control group after 60 min rest, z = −0·21, p = 0·833, and a minimal effect size (r = 0·05). There were significant differences between the intervention group and the control group in the level of STAI-Y before (p = 0·007) and after (p = 0·001) TM/rest.
STAI-Y: discussion In spite of the fact that we only included 20 participants, the results revealed that TM significantly decreased anxiety levels in patients undergoing elective aortic surgery. This indicates that the STAI-Y instrument was sensitive enough to evaluate anxiety in small groups. Decrease in STAI-Y score after massage has been reported in other studies (Garner et al., 2008; Hatayama et al., 2008; Field et al., 2009). The effect of massage on self-rated anxiety levels could be explained by results from our previous study, showing that pleasant human touch (pressure 2·5 N and velocity 1–5 cm/s) activates brain regions involved in emotional processes (Lindgren et al., 2012).
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Table 2 Anxiety levels and stress-related outcome variables are presented as mean and standard deviation before and after TM/control Before TM/control 8·00 p.m.
Cortisol/s (nmol/L) Insulin/s (mIU/L) Glucose/s (mmol) SBP (mmhg) DBP (mmhg) RF (min) Oxygen Saturation (%) STAI-Y (totscor)
Control TM Control TM Control TM Control Tm Control TM Control TM Control TM Control TM
After TM/control
11·30 p.m.
1·30 a.m.
7·00 p.m.
8·00 a.m.
n
m
SD
n
m
SD
n
m
SD
n
m
SD
n
m
SD
10 10 10 10 10 10
591·0 521·1 27·2 37·0 7·24 6·83
330·3 252·6 13·9 15·4 1·76 1·69
10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10
558·4 443·3 37·0 56·5 7·81 7·20 132·8 124·9 65·4 55·0 17·7 18·9 96·2 95·7 46·4 35·6
244·3 169·5 15·9 26·8 1·81 1·80 17·7 15.3 11·9 11·9 4·8 6·8 2·7 1·8 8·6 5·9
10 9 10 9 9 10 10 10 10 10 10 10 10 10 10 10
465·8 539·2 41·8 35·9 7·83 6·49 134·7 124.3 65·1 67·9 19·2 15·6 96·1 96·3 46·6 27·4
283·5 181·3 33·6 21·4 2·24 1·34 19·8 13·5 13·4 15·7 4·7 7·5 2·1 1·2 11·0 7·1
10 10 10 9 10 10
633·9 466·9 49·7 53·0 8·28 7·69
311·1 221·8 47·61 31·8 2·57 1·99
9 10 10 9 10 10
567·4 614·2 32·7 42·8 7·00 7·12
374·1 187·2 26·1 24·1 2·26 2·19
SBP, systolic blood pressure; DBP, diastolic blood pressure; RF, respiratory frequency; STAI-Y, State-Trait Anxiety Inventory Form Y.
Activity in the pregenual anterior cingulated cortex is thought to regulate negative emotions, such as anxiety (Etkin et al., 2006; Etkin et al., 2010; Etkin et al., 2011). In addition, activity in this brain area has been found to correlate with the STAI-Y instrument (Klumpp et al., 2011; Krug and Carter, 2010). Compared with controls, the TM group initially had significantly lower levels of anxiety. This could be caused by other factors, but one possible explanation could be the anticipation of the TM treatment. It has been suggested that complementary treatment relies partly on feelings of anticipation, safety and thrust. It has also been shown that these feelings activate limbic brain areas (Esch et al., 2004). Although the intervention group had a lower initial anxiety level, their decrease in anxiety after TM was nevertheless significant within the group, showing that TM had an effect on anxiety levels. The anxiety level in the control group, in contrast, was constant over time, and showed stability on the instrument. The sensitivity of the instrument and the neural and behavioural findings indicate that the STAI-Y is a valid instrument for evaluating the effects of TM (Moyer et al., 2004; Klumpp et al., 2011; Lindgren et al., 2012).
Blood pressure, respiratory frequency and oxygen saturation No significant changes in SBP, diastolic blood pressure (DBP), respiratory frequency or oxygen saturation
were observed within either the intervention group or the control group after TM. There were no differences between the intervention and control groups before or after TM/rest (Table 2).
Blood pressure, respiratory frequency and oxygen saturation: discussion The major concern in this study was the low number of participants. Controlled randomized design needs several participants which can be a problem as complex interventions often are time-consuming (Blackwood, 2006; Campbell et al., 2007). In our study a homogenous group of patients was selected in order to minimize confounders. This decision made it difficult to increase numbers of participants, and the large inter-individual differences (standard deviations) in respective stressrelated outcome parameters indicated a need for a larger sample size. The insignificant results in stress-related outcome parameters could also have a physiological explanation. Surgery itself activates a strong physiological stress response (Banz et al., 2011), and although anxiety levels were reduced by TM, the mental responses were not powerful enough to change the physiological stress-related outcome parameters. The effect of TM on stress reduction could perhaps be measured in patients not suffering from surgical stress. For example, Billhult et al. (2009) found decreased blood pressure and heart rate after TM in breast cancer patients.
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Table 3 HRV components presented in mean and standard deviation before, during and after TM/control Before TM/control HRV components RR totHRV HF LF VLF LF/HFratio
Control TM Control TM Control TM Control TM Control TM Control TM
During TM/control
After TM/control
5 min m (SD)
10 min m (SD)
30 min m (SD)
50 min m (SD)
5 min m (SD)
0·809 (0·10) 0·848 (0·10) 2·583 (0·56) 2·660 (0·58) 1·682 (0·53) 1·509 (0·62) 1·832 (0·68) 1·933 (0·52) 2·346 (0·60) 2·530 (0·51) 0·154 (0·47) 0·382 (0·40)
0·805 (0·10) 0·849 (0·09) 2·650 (0·55) 2·649 (0·49) 1·746 (0·53) 1·515 (0·47) 1·801 (0·73) 1·846 (0·52) 2·446 (0·56) 2·505 (0·52) 0·057 (0·54) 0·220 (0·38)
0.795 (0·12) 0·844 (0·11) 2·483 (0·52) 2·652 (0·49) 1·568 (0·56) 1·512 (0·55) 1·776 (0·61) 1·886 (0·47) 2·189 (0·61) 2·525 (0·45) 0·209 (0·55) 0·242 (0·30)
0·798 (0·10) 0·848 (0·12) 2·621 (0·50) 2·621 (0·45) 1·716 (0·49) 1·519 (0·49) 1·865 (0·66) 1·974 (0·36) 2·402 (0·50) 2·458 (0·42) 0·148 (0·40) 0·368 (0·28)
0·782 (0·11) 0·804 (0·12) 2·595 (0·54) 2·810 (0·45) 1.629 (0·42) 1·405 (0·49) 1·853 (0·62) 1·908 (0·40) 2·341 (0·61) 2·721 (0·42) 0·224 (0·42) 0·447 (0·31)
RR, RR interval; totHRV, total heart rate variability; HF, high frequency; LF, low frequency; VLF, very low frequency.
HRV There were no significant interactions or main effects within or between the intervention group and the control group on any of the HRV components (Table 3).
Serum cortisol, serum insulin and serum glucose There were no significant interactions or main effects within or between intervention group and control group in serum cortisol, insulin or glucose levels (Table 3).
HRV: discussion HRV has been used in other massage studies with various results. Delaney et al. (2002) and Diego and Field (2009) found increased parasympathetic nervous activity, while Hatayama et al. (2008) found increased sympathetic nervous activity. In a previous study, in healthy volunteers receiving TM we found decreased activity in the sympathetic nervous system and a compensatory decrease in the parasympathetic nervous system (Lindgren et al., 2010). The mental influence on the autonomic nervous system involves a complex neural network in the brain and may modulate the autonomic nervous system in diverse directions (Medford and Critchley, 2010). One theory maintains that the two branches of the autonomic nervous system act synergistically to optimize autonomic balance (Wiklund et al., 2000; Paton et al., 2005; Paton et al., 2006). HRV reflects changes in autonomic nervous activity, while simple heart rate is more related to the average levels of the activity in the autonomic nervous system (Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology, 1996). However, in this study we did not find any differences either within or between groups in any HRV component. This could partly be explained by the low number of participants, as the response during TM might have been masked by the large intra-individual variability. 274
Serum cortisol, serum insulin and serum glucose: discussion There are several aspects to consider when cortisol is used as an outcome parameter. Cortisol levels change normally during the day along with circadian rhythms (Weitzman, 1976). This makes the timing of sampling important. In our study we followed cortisol levels over the day. Cortisol levels tended to decrease in the evening (7·00 p.m.) in the TM group, while corresponding values increased in the control group, but the differences were not significant. Free cortisol can be measured in saliva (Perogamvros et al., 2010), but dry mouth can be a problem in post-operative patients (Dennesen et al., 2003), and in our pilot study it was impossible to swab enough saliva for cortisol samples. We therefore used serum cortsiol as an outcome parameter, even though it reflects the bounded cortisol level (Mueller and Potter, 1981). Cortisol as an outcome parameter in the evaluation of massage has recently been reviewed, and the authors found the effects of massage treatment on cortisol levels in the included studies were very small (Moyer et al., 2011). Acute stress induces a metabolic response, which may contribute to hyperglycaemia with, among other mechanisms, elevated blood glucose levels, altered insulin production and peripheral insulin resistance (Losser et al., 2010). Correlation has been
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found between elevated blood glucose and mortality in critically ill patients, although the explanatory mechanisms are debatable (Van den Berghe, 2012). Our hypothesis was that stress reduction induced by TM might dampen such a metabolic response and modulate glucose and insulin levels. We could not confirm this hypothesis. The participants’ blood glucose levels were stable, but insulin levels varied considerably.
REFLECTION Developing a complex intervention The MRC framework provides a constructive guideline (Craig et al., 2008) for the development of complex intervention studies such as TM, as reported in other nursing intervention studies (Maindal et al., 2010; Kirkevold et al., 2012). In our project it was important to understand the mechanisms that could explain observed responses during and after TM in order to select outcome parameters more accurately and explain results more easily. In nursing studies it is important not only to analyse effects on different outcome parameters or to explore experiences, but also to establish hypotheses out of basic research. If there is a lack of basic science in the research topics, we must be open minded and ready to examine new approaches (Richards and Borglin, 2011). Hallberg (2009) discusses the importance of using different methodological approaches and including science from different fields to provide depth to studies of clinical problems or phenomena. The systematic literature review was difficult to carry out because massage is described so rarely in different studies. Future studies of massage treatments that describe the pressure and velocity of the massage will be valuable in providing evidence of reliability and comparability between studies in order to facilitate future meta-analysis. Even if the pressure is difficult to measure, qualitative descriptions such as ‘harder than a brushstroke, but lighter than muscle massage’ would still be more valuable than no measure or description at all.
Assessing feasibility and piloting methods Our experience of evaluating TM is in line with the literature; the need for pilot testing in the same context that the study will be carried out cannot be stressed enough (Campbell et al., 2007; Mohler et al., 2012). ¨ Although this step is time-consuming and expensive, the long-term benefits are considerable. By sharing our experience of and reflection on our intervention, we hope to contribute to improvements in similar intervention studies in the future.
Reporting and evaluating a complex intervention A between–within design is appropriate to studies evaluating complex interventions. There are, however, some problems with using a randomized control trial design; for example, blinding. Several contextual factors might modulate the intervention effect (Blackwood, 2006). Nevertheless, randomized control is considered to be the most robust method to avoid selection bias (Craig et al., 2008). In our study the randomization procedure was not a problem, but the blinding was, for obvious reasons, impossible. As the initial STAI-Y score was lower for the TM group than for the control group, we may hypothesize that expectation of pleasure, comfort or relief may have an effect in addition to the effect of TM. Therefore, it would have been interesting to measure STAI-Y score after randomization, but before the participant had been informed of their group assignment. If the expectation effect had been of interest, the STAI-Y score could have been measured both before and after patients were informed of their group classification. Another major problem is the difficulty of recruiting enough participants for intervention studies. The choice seems to be between a small homogenous group with fewer confounders and a larger group given to increased variability and more confounding factors. It may be possible to find significant differences in some of the outcome parameters if the participant rate were increased. Nevertheless, a significant difference in STAI-Y score before and after TM was observed in the intervention group with a large effect size, indicating that the sample size for this outcome parameter was appropriate. Our study results and those of Henricson et al. (2008) showed no significant differences in stressrelated outcome parameters in patients cared for in ICU after receiving TM. This may be because of the fact that patients early in the post-operative phase or trauma phase have a high physiological stress response and their reduction in mental stress may be too small to actually affect their autonomic and endocrine response. For future studies evaluating the effects of massage, we suggest that measurements of mental parameters such as the STAI-Y should be used as primary outcome parameters. If stress-related outcome parameters are of interest, it is important also to adjust for the disease effect. Despite the low number of participants, there was a large effect on self-rated STAI-Y score after the participants received TM, indicating reduced anxiety. This has also been confirmed in other studies and may be explained by our previous functional magnetic resonance imaging results.
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CONCLUSION AND IMPLICATION FOR PRACTICE It is important to develop a theoretical basis for the study of TM’s efficacy in relieving physiological stress and self-reported anxiety. Different methodological approaches can be useful, and the MRC framework is a useful guideline for the development, evaluation and
reporting of complex nursing interventions such as TM. Results from this study revealed that TM can reduce anxiety. TM could therefore be a nursing intervention to use as an adjunct to conventional care and may help to minimize the use of medication and thus its side effects.
WHAT IS KNOWN ABOUT THIS TOPIC • Massage induces positive emotions in the receiver. • Models are lacking to explain observed responses during and after massage. • More research evaluating the design, methods and results of studies of intervention such as TM are necessary for the improvement of future interventions. WHAT THIS PAPER ADDS • • • •
TM can reduce anxiety levels in patients cared for in intensive and post-operative care. An example of the MRC framework applied to the development of massage studies. A proposal for better standardization of massage treatment in order to minimize confounders. A preliminary theoretical framework to explain responses during and after TM.
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Touch massage: a pilot study of a complex intervention ¨ Marcus Karlsson, Urban Wiklund Lenita Lindgren, Stefan Lehtipalo, Ola Winso, and Christine Brulin ABSTRACT Objectives: To report and evaluate a complex touch massage intervention according to the British Medical Research Council framework. This study aimed to evaluate the effects of touch massage on levels of anxiety and physiological stress in patients scheduled for elective aortic surgery. Background: The use of touch massage has increased during the past decade but no systematic studies have been implemented to investigate the effectiveness of such treatment. It is important to conduct multidisciplinary investigations into the effects of complex interventions such as touch massage. For this, the British Medical Research Council has provided a useful framework to guide the development, piloting, evaluation and reporting of complex intervention studies. Method: A pilot study with a randomized controlled design including 20 patients (10 + 10) scheduled for elective aortic surgery. Selected outcome parameters included; self-reported anxiety, measured by the State-Trait Anxiety Inventory Form Y instrument, and physiological stress, measured by heart rate variability, blood pressure, respiratory frequency, oxygen saturation and concentrations of cortisol, insulin and glucose in serum. Results: There were significant differences in self-reported anxiety levels before and after touch massage (p = 0·007), this was not observed in the control group (p = 0·833). There was a significant difference in self-reported anxiety levels between the touch massage group and the control group after touch massage and rest (p = 0·001). There were no significant differences in physiological stress-related outcome parameters between patients who received touch massage and controls. Conclusion: In our study, touch massage decreased anxiety levels in patients scheduled for elective aortic surgery, and the British Medical Research Council framework was a useful guideline for the development, evaluation and reporting of a touch massage intervention. Relevance to clinical practice: Touch massage can reduce patients’ anxiety levels and is thus an important nursing intervention in intensive and post-operative care. Key words: Adult intensive care • Care nursing • Clinical research • Complex interventions • Intensive • Psychological care of patients • Research
BACKGROUND Patients cared for in intensive care units sometimes show strong responses to touch massage (TM) including decreased heart rate, blood pressure and
Authors: L Lindgren, RN, MSn, PhD, Department of Nursing, Umea˚ University and Department of Surgical and Perioperative Science ˚ Sweden; S Lehtipalo, MD, Chief Anesthesiology and Intensive Care, Umea, Physician, Department of Surgical and Perioperative Science Anesthesiology ˚ Sweden; O Winso, ¨ Professor, and Intensive Care, Umea˚ University, Umea, Chief Physician, Department of Surgical and Perioperative Science ˚ Sweden; Anesthesiology and Intensive Care, Umea˚ University, Umea, M Karlsson, Research Engineer, Master of Science, Department of ˚ Sweden; U Wiklund, Biomedical Engineering, Umea˚ University, Umea, associate Professor, Research Engineer, Department of Biomedical ˚ Sweden; C Brulin, Professor, RN, Engineering Umea˚ University, Umea, ˚ Sweden MSn, Department of Nursing, Umea˚ University, Umea, Address for correspondence: L Lindgren, Department of Nursing, ˚ Sweden Umea˚ University, SE-901 87 Umea, E-mail: [email protected]
respiratory frequency. Patients have also reported less anxiety, pain and stress after TM. From these observations we hypothesized that TM influences both physical and emotional outcome parameters. To test this hypothesis we evaluated TM in patients scheduled for elective aortic surgery and thereafter cared for in an intensive care unit. A challenge in health care is the evaluation of nursing interventions such as TM in order to develop and improve nursing care. Generally, these interventions are time-consuming and complex, with several confounders to be taken into account. The British Medical Research Council (MRC) framework provides a systematic guideline containing methodological aspects for the development and evaluation of complex interventions. The four key elements of the development and evaluation process in the MRC framework are described as development, feasibility/piloting, evaluation and implementation (Craig et al., 2008). In this
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paper we use the developing, piloting and evaluation phases to describe and reflect upon methodological problems such as complexity and selected outcomes when evaluating TM in clinical praxis. Furthermore, we make recommendations to improve similar intervention studies in the future. The phase of the MRC framework, covering long-term implementation, is not addressed in this paper.
Developing a complex intervention One important issue is the practical and clinical effectiveness of an intervention (Haynes, 1999). When our project began by observing responses to TM in patients in a clinical setting, the practical effectiveness and use of the intervention were apparent. According to MRC, identifying the research question and the existing evidence base is essential in the first stage (van Meijel et al., 2004; Craig et al., 2008). Massage studies have been evaluated and presented in reviews (Ernst, 2009; Harris and Richards, 2010; Moraska et al., 2010) and most of which call for larger randomized controlled trials. The studies reported different results in some outcome parameters. It is important to take into account that massage techniques using different amounts of force and velocity activate different receptors and fibres. Therefore, it is difficult to compare study results from deep massage involving both skin and muscles with lighter massage only involving skin. For this reason, a custom-made device was constructed for this project to measure the force (2·5 N) and velocity (1–5 cm/s) applied during TM (Lindgren et al., 2012). We use the term ‘touch massage’ to describe gentle, soft, light, tactile massage that probably involves only the skin (Lindgren et al., 2010). Billhult et al. (2009) evaluated the effects of light massage (0·0090 kg/cm2 pressure) on physiological outcome parameters, and concluded that light massage may have short-term effects on systolic blood pressure (SBP) and heart rate. Other studies of massage described as ‘light’, ‘tactile’, ‘soft’, or ‘gentle’ reported altered emotions after massage treatments (Andersson et al., 2009; Cronfalk et al., 2009; Henricson et al., 2009). The next step after evaluating existing evidence about the intervention was to identify or develop theories about how the intervention works. There is a dearth of relevant physiological models explaining the observed responses to massages interventions; however, one theory suggests that activation of pressure receptors in the skin activates the parasympathetic nervous system (Field et al., 2010). Another theory posits that massage releases oxytocin, a hormone suggested to be involved in positive social experiences (Uvn¨as-Moberg, 1998). Evidence of how massage and pleasant human touch activate the human brain, 270
however, is sparse (Lindgren et al., 2012). Recently it has been suggested that nursing research needs to add both experimental and translational research to more descriptive and introspective studies (Richards and Borglin, 2011). We therefore performed two studies in healthy volunteers to develop a theoretical base. In our first study the aim was to evaluate the effects of TM on stress reactions using heart rate variability (HRV) to measure alterations in autonomic nervous system activity. The results showed that TM was associated with decreased activity in the sympathetic nervous system activity along with a compensatory decrease in the parasympathetic nervous system (Lindgren et al., 2010). In the second study we evaluated brain responses during TM using functional magnetic resonance imaging. The results revealed that TM activated a brain region, the pregenual anterior cingulated cortex (Lindgren et al., 2012), containing a high density of opioid receptors (Vogt, 2005). The pregenual anterior cingulated cortex is activated during happiness and pleasure (Vogt, 2005; Rolls, 2010), and induced activity in this brain region may reduce the effects of negative stimuli (Etkin et al., 2006). Consistent with our findings, a review of massage outcome parameters stated that the most pronounced effects of massage were decreased anxiety and decreased depression (Moyer et al., 2004). Thus, our findings indicate that TM has effect on emotions by activating specific brain areas, which as a consequence may alter the activity of the autonomic nervous system.
Assessing feasibility and piloting methods To test feasibility, practicability and acceptability according to the MRC second stage (Craig et al., 2008), we used our first study in healthy volunteers (Lindgren et al., 2010) to evaluate appropriate outcome parameters and adjust the intervention for the current study evaluating TM in a group of patients. From the study in healthy volunteers, a number of outcome parameters such as extracellular levels of glucose, lactate, glycerol and pyruvate measured by microdialysis were eliminated from further consideration. The TM intervention was also found to be adaptable to use on additional body parts (hands, feet, legs and arms), and based on HRV results, the massage time could be shortened from 120 to 60 min (Lindgren et al., 2010).
Evaluating and reporting a complex intervention As an example of how to report and evaluate a complex intervention, we will describe and discuss the results of a pilot study on the effects of TM in patients scheduled for elective aortic surgery. The aim of the pilot study was to evaluate anxiety levels and
© 2013 The Authors. Nursing in Critical Care © 2013 British Association of Critical Care Nurses
Touch massage: a pilot study of a complex intervention
stress-related outcome parameters in patients scheduled for elective aortic surgery. The selected outcomes were self-reported anxiety, HRV, blood pressure, respiratory frequency, oxygen saturation and concentrations of cortisol, insulin and glucose in serum. In the last part of the paper we will make recommendations to improve future similar intervention studies.
METHODS After approval from the Regional Ethical Review Board at Ume˚a University Hospital (Dnr 07-183M), patients scheduled for elective aortic surgery between October 2009 and June 2011 at Ume˚a University Hospital were invited to participate in this study. Of 32 individuals invited, 27 agreed to participate. Seven of the participants were excluded because of post-operative complications. Twenty patients cared for in intensive care settings (mean age = 65·9 years, SD = 5·1) were block randomized to either a control (n = 10) or an intervention (n = 10) group. The block randomization employed opaque envelopes with assigned treatment group per participant. All participants had cardiovascular disease and antihypertensive medication. Overall, the participants did not differ between groups in diseases or medications. Pre-operative values are shown in Table 1.
Intervention Participants in the intervention group received one TM intervention performed on the hands, arms, feet and legs for 60 min. TM was performed with a pressure of about 2·5 N and a velocity of 1–5 cm/s (Lindgren et al., 2012) with long stroking movements. Around knees, ankles, toes, elbows, wrists and fingers circular movements were applied. Neutral oil was used to avoid stick-and-slip-movements of the skin. Pressure and velocity were measured by a
custom-made device (Lindgren et al., 2012) The study took place in an intensive care unit in northern Sweden, and the intervention was performed by four specially trained and massage-educated staff members, including one of the authors (L. L.), who performed TM on 4 of the 10 occasions. The control group rested in the same setting in the presence of health professionals. The staff was instructed not to talk to the patients during TM intervention and control supervised rest. The milieu and monitoring in the intensive care unit remained as usual.
Measurements and analyses The Swedish version of State-Trait Anxiety Inventory Form Y (STAI-Y) instrument was used to assess selfreported anxiety levels. The STAY-Y was developed to measure state-anxiety as a temporary condition of anxiety and trait-anxiety as a long-term condition. The instrument has good construct validity, internal consistency, and test-retest validity (Spielberger, 1972; Spielberger et al., 1983). In this study STAY-Y was used to evaluate immediate changes in state-anxiety. The 20 items were summed for a total score ranging from 20 to 80, with higher scores reflecting higher levels of anxiety. Activity in the autonomic nervous system (both sympathetic and parasympathetic) before, during and after TM was measured through analysis of HRV (beatto-beat fluctuations in heart rate (Lindgren et al., 2010). Non-invasive blood pressure measurements during and after TM/control were recorded using a blood pressure cuff (Dura-cuff ref 2203 connected to Marquette Solar 8000M monitor, GE Healthcare, Milwaukee, WI, USA). Changes in respiratory frequency were recorded with an electrocardiogram and oxygen saturation measured on a saturation probe (Nellcor) placed on a digit and further transferred to Marquette Solar 8000 M monitor (GE Healthcare). Data were
Table 1 Background characteristic and values before surgery in respective group for all participants (10 + 10) presented in mean and standard deviation. Differences between groups are presented as p value
Age Days after surgery SBP (mmhg) DBP (mmhg) Oxygen saturation (%) Fasting glucose/s (mmol) Fasting insulin/s (mIU/L) Fasting cortisol/s (nmol/L)
TM group m (SD)
Control group m (SD)
p value
63·3 (5·3) 1·9 (0·7) 141·08 (23·05) 75·06 (11·05) 96·05 (1·05) 6·06 (2·05) 86·00 (75·06) 500·09 (214·07)
69·6 (3·4) 2·0 (1·4) 152·5 (22·6) 89·8 (7·01) 97·08 (1·07) 7·07 (2·09) 77·00 (86·00) 525·02 (138·01)
0·021 0·627 0·481 0·008 0·067 0·449 0·962 0·594
Days after surgery, how many days from surgery until the participants were circulatory, respiratory and neurological stable; SBP, systolic blood pressure; DBP, diastolic blood pressure.
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sampled directly from the monitor to a software computer system (Picic, Critical Care Manager, care suite 8.2, Wakefield, UK) and later extracted. For evaluation of hypothalamic-pituitary-adrenal activity and glucose metabolism, measurements of cortisol, glucose and insulin in serum were performed. Pre-operative blood samples were taken from a venous catheter (18 G 32 mm Smiths Medical, Milano, Italy). Post-operative blood samples were taken from an arterial catheter (20 G/1·0·10 mm × 45 mm, Becton Dickinson, Singapore). Serum cortisol levels were analysed in clinical routine in an accredited laboratory by Roche reagents on Cobas 6000/8000 analysers. Glucose in serum was analysed using Ortho Vitros GLU slides on a Vitros 5.1 FS analyser. Insulin in serum was analysed using Roche Elecsys Insulin reagents on a Modular E170 analyser. All analyses were conducted in the Clinical Chemical Laboratory at the University Hospital, Ume˚a, Sweden.
groups. Following Bonferroni correction, α level was set at p < 0·01 (Pallant, 2005). When data (interval data) were repeatedly measured, a parametric, mixed between–within subjects analysis of variance was conducted (blood pressure, respiratory frequency, oxygen saturation, HRV, cortisol, insulin and glucose) (Tabachnick and Fidell, 2007). Skewed data was log-transformed and tested for normality. All data are presented as mean (m) and standard deviation (SD) before log-transformation. Owing to the sensitivity of the mixed between–within subjects analysis of variance test and the recommendation by Pallant (2005), a more conservative α level of p < 0·001 was set for this test. The statistical analyses were performed with SPSS software (version 18.0, SPSS Inc., Chicago, IL, USA).
Procedure
As the focus of this paper was to link the MRC theoretical framework (Craig et al., 2008) with experiences of a clinical intervention study, the results and discussion are presented together, followed by a section reflecting upon the results/discussion. Participants’ baseline characteristics and pre-operative physiological variables are summarized in Table 1. Mean value and SD for all outcome parameters are presented in Table 2.
In the morning, the day before surgery, baseline blood pressure, heart rate and oxygen saturation were recorded and blood samples (cortisol, insulin and glucose) were collected. At 8·00 a.m., the day after surgery, neurological, respiratory and circulatory parameters were evaluated and blood samples (cortisol, insulin and glucose) were collected again. If the patients circulatory, respiratory or neurological systems were unstable, the assessments were performed every morning at 8·00 a.m. until they were stable. After reaching circulatory, respiratory and neurological stability patients were randomized to either the control or the intervention group. The intervention or control procedure took place between 12.30 a.m. and 1.30 p.m. on the day of randomization. Immediately before and after the intervention/control a set of data was collected including self-reported anxiety level and the outcome parameters described above. Later that evening (at 7·00 p.m.) and the following morning (at 8·00 a.m.) additional blood samples (cortisol, insulin and glucose) were collected. Because of normal diurnal changes in hormone levels, the samples were collected at the same time of the day. Fluids and medications given prior to and in conjunction with interventions were documented. All patients received a routine pre-operative epidural catheter with continuous analgesic infusion for post-operative analgesia.
Statistics When testing for differences in STAI score (ordinal data) non-parametric tests were used. Wilcoxon rank test was used to test for differences within groups (before and after intervention/control) and Mann-Whitney U test was used for testing between 272
RESULTS
STAI-Y There was a significant decrease in the total STAIY score in the intervention group after 60 min TM, z = −2.71, p = 0·007, with a large effect size (r = 0·60), but no such decrease was found in the control group after 60 min rest, z = −0·21, p = 0·833, and a minimal effect size (r = 0·05). There were significant differences between the intervention group and the control group in the level of STAI-Y before (p = 0·007) and after (p = 0·001) TM/rest.
STAI-Y: discussion In spite of the fact that we only included 20 participants, the results revealed that TM significantly decreased anxiety levels in patients undergoing elective aortic surgery. This indicates that the STAI-Y instrument was sensitive enough to evaluate anxiety in small groups. Decrease in STAI-Y score after massage has been reported in other studies (Garner et al., 2008; Hatayama et al., 2008; Field et al., 2009). The effect of massage on self-rated anxiety levels could be explained by results from our previous study, showing that pleasant human touch (pressure 2·5 N and velocity 1–5 cm/s) activates brain regions involved in emotional processes (Lindgren et al., 2012).
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Touch massage: a pilot study of a complex intervention
Table 2 Anxiety levels and stress-related outcome variables are presented as mean and standard deviation before and after TM/control Before TM/control 8·00 p.m.
Cortisol/s (nmol/L) Insulin/s (mIU/L) Glucose/s (mmol) SBP (mmhg) DBP (mmhg) RF (min) Oxygen Saturation (%) STAI-Y (totscor)
Control TM Control TM Control TM Control Tm Control TM Control TM Control TM Control TM
After TM/control
11·30 p.m.
1·30 a.m.
7·00 p.m.
8·00 a.m.
n
m
SD
n
m
SD
n
m
SD
n
m
SD
n
m
SD
10 10 10 10 10 10
591·0 521·1 27·2 37·0 7·24 6·83
330·3 252·6 13·9 15·4 1·76 1·69
10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10
558·4 443·3 37·0 56·5 7·81 7·20 132·8 124·9 65·4 55·0 17·7 18·9 96·2 95·7 46·4 35·6
244·3 169·5 15·9 26·8 1·81 1·80 17·7 15.3 11·9 11·9 4·8 6·8 2·7 1·8 8·6 5·9
10 9 10 9 9 10 10 10 10 10 10 10 10 10 10 10
465·8 539·2 41·8 35·9 7·83 6·49 134·7 124.3 65·1 67·9 19·2 15·6 96·1 96·3 46·6 27·4
283·5 181·3 33·6 21·4 2·24 1·34 19·8 13·5 13·4 15·7 4·7 7·5 2·1 1·2 11·0 7·1
10 10 10 9 10 10
633·9 466·9 49·7 53·0 8·28 7·69
311·1 221·8 47·61 31·8 2·57 1·99
9 10 10 9 10 10
567·4 614·2 32·7 42·8 7·00 7·12
374·1 187·2 26·1 24·1 2·26 2·19
SBP, systolic blood pressure; DBP, diastolic blood pressure; RF, respiratory frequency; STAI-Y, State-Trait Anxiety Inventory Form Y.
Activity in the pregenual anterior cingulated cortex is thought to regulate negative emotions, such as anxiety (Etkin et al., 2006; Etkin et al., 2010; Etkin et al., 2011). In addition, activity in this brain area has been found to correlate with the STAI-Y instrument (Klumpp et al., 2011; Krug and Carter, 2010). Compared with controls, the TM group initially had significantly lower levels of anxiety. This could be caused by other factors, but one possible explanation could be the anticipation of the TM treatment. It has been suggested that complementary treatment relies partly on feelings of anticipation, safety and thrust. It has also been shown that these feelings activate limbic brain areas (Esch et al., 2004). Although the intervention group had a lower initial anxiety level, their decrease in anxiety after TM was nevertheless significant within the group, showing that TM had an effect on anxiety levels. The anxiety level in the control group, in contrast, was constant over time, and showed stability on the instrument. The sensitivity of the instrument and the neural and behavioural findings indicate that the STAI-Y is a valid instrument for evaluating the effects of TM (Moyer et al., 2004; Klumpp et al., 2011; Lindgren et al., 2012).
Blood pressure, respiratory frequency and oxygen saturation No significant changes in SBP, diastolic blood pressure (DBP), respiratory frequency or oxygen saturation
were observed within either the intervention group or the control group after TM. There were no differences between the intervention and control groups before or after TM/rest (Table 2).
Blood pressure, respiratory frequency and oxygen saturation: discussion The major concern in this study was the low number of participants. Controlled randomized design needs several participants which can be a problem as complex interventions often are time-consuming (Blackwood, 2006; Campbell et al., 2007). In our study a homogenous group of patients was selected in order to minimize confounders. This decision made it difficult to increase numbers of participants, and the large inter-individual differences (standard deviations) in respective stressrelated outcome parameters indicated a need for a larger sample size. The insignificant results in stress-related outcome parameters could also have a physiological explanation. Surgery itself activates a strong physiological stress response (Banz et al., 2011), and although anxiety levels were reduced by TM, the mental responses were not powerful enough to change the physiological stress-related outcome parameters. The effect of TM on stress reduction could perhaps be measured in patients not suffering from surgical stress. For example, Billhult et al. (2009) found decreased blood pressure and heart rate after TM in breast cancer patients.
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Table 3 HRV components presented in mean and standard deviation before, during and after TM/control Before TM/control HRV components RR totHRV HF LF VLF LF/HFratio
Control TM Control TM Control TM Control TM Control TM Control TM
During TM/control
After TM/control
5 min m (SD)
10 min m (SD)
30 min m (SD)
50 min m (SD)
5 min m (SD)
0·809 (0·10) 0·848 (0·10) 2·583 (0·56) 2·660 (0·58) 1·682 (0·53) 1·509 (0·62) 1·832 (0·68) 1·933 (0·52) 2·346 (0·60) 2·530 (0·51) 0·154 (0·47) 0·382 (0·40)
0·805 (0·10) 0·849 (0·09) 2·650 (0·55) 2·649 (0·49) 1·746 (0·53) 1·515 (0·47) 1·801 (0·73) 1·846 (0·52) 2·446 (0·56) 2·505 (0·52) 0·057 (0·54) 0·220 (0·38)
0.795 (0·12) 0·844 (0·11) 2·483 (0·52) 2·652 (0·49) 1·568 (0·56) 1·512 (0·55) 1·776 (0·61) 1·886 (0·47) 2·189 (0·61) 2·525 (0·45) 0·209 (0·55) 0·242 (0·30)
0·798 (0·10) 0·848 (0·12) 2·621 (0·50) 2·621 (0·45) 1·716 (0·49) 1·519 (0·49) 1·865 (0·66) 1·974 (0·36) 2·402 (0·50) 2·458 (0·42) 0·148 (0·40) 0·368 (0·28)
0·782 (0·11) 0·804 (0·12) 2·595 (0·54) 2·810 (0·45) 1.629 (0·42) 1·405 (0·49) 1·853 (0·62) 1·908 (0·40) 2·341 (0·61) 2·721 (0·42) 0·224 (0·42) 0·447 (0·31)
RR, RR interval; totHRV, total heart rate variability; HF, high frequency; LF, low frequency; VLF, very low frequency.
HRV There were no significant interactions or main effects within or between the intervention group and the control group on any of the HRV components (Table 3).
Serum cortisol, serum insulin and serum glucose There were no significant interactions or main effects within or between intervention group and control group in serum cortisol, insulin or glucose levels (Table 3).
HRV: discussion HRV has been used in other massage studies with various results. Delaney et al. (2002) and Diego and Field (2009) found increased parasympathetic nervous activity, while Hatayama et al. (2008) found increased sympathetic nervous activity. In a previous study, in healthy volunteers receiving TM we found decreased activity in the sympathetic nervous system and a compensatory decrease in the parasympathetic nervous system (Lindgren et al., 2010). The mental influence on the autonomic nervous system involves a complex neural network in the brain and may modulate the autonomic nervous system in diverse directions (Medford and Critchley, 2010). One theory maintains that the two branches of the autonomic nervous system act synergistically to optimize autonomic balance (Wiklund et al., 2000; Paton et al., 2005; Paton et al., 2006). HRV reflects changes in autonomic nervous activity, while simple heart rate is more related to the average levels of the activity in the autonomic nervous system (Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology, 1996). However, in this study we did not find any differences either within or between groups in any HRV component. This could partly be explained by the low number of participants, as the response during TM might have been masked by the large intra-individual variability. 274
Serum cortisol, serum insulin and serum glucose: discussion There are several aspects to consider when cortisol is used as an outcome parameter. Cortisol levels change normally during the day along with circadian rhythms (Weitzman, 1976). This makes the timing of sampling important. In our study we followed cortisol levels over the day. Cortisol levels tended to decrease in the evening (7·00 p.m.) in the TM group, while corresponding values increased in the control group, but the differences were not significant. Free cortisol can be measured in saliva (Perogamvros et al., 2010), but dry mouth can be a problem in post-operative patients (Dennesen et al., 2003), and in our pilot study it was impossible to swab enough saliva for cortisol samples. We therefore used serum cortsiol as an outcome parameter, even though it reflects the bounded cortisol level (Mueller and Potter, 1981). Cortisol as an outcome parameter in the evaluation of massage has recently been reviewed, and the authors found the effects of massage treatment on cortisol levels in the included studies were very small (Moyer et al., 2011). Acute stress induces a metabolic response, which may contribute to hyperglycaemia with, among other mechanisms, elevated blood glucose levels, altered insulin production and peripheral insulin resistance (Losser et al., 2010). Correlation has been
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found between elevated blood glucose and mortality in critically ill patients, although the explanatory mechanisms are debatable (Van den Berghe, 2012). Our hypothesis was that stress reduction induced by TM might dampen such a metabolic response and modulate glucose and insulin levels. We could not confirm this hypothesis. The participants’ blood glucose levels were stable, but insulin levels varied considerably.
REFLECTION Developing a complex intervention The MRC framework provides a constructive guideline (Craig et al., 2008) for the development of complex intervention studies such as TM, as reported in other nursing intervention studies (Maindal et al., 2010; Kirkevold et al., 2012). In our project it was important to understand the mechanisms that could explain observed responses during and after TM in order to select outcome parameters more accurately and explain results more easily. In nursing studies it is important not only to analyse effects on different outcome parameters or to explore experiences, but also to establish hypotheses out of basic research. If there is a lack of basic science in the research topics, we must be open minded and ready to examine new approaches (Richards and Borglin, 2011). Hallberg (2009) discusses the importance of using different methodological approaches and including science from different fields to provide depth to studies of clinical problems or phenomena. The systematic literature review was difficult to carry out because massage is described so rarely in different studies. Future studies of massage treatments that describe the pressure and velocity of the massage will be valuable in providing evidence of reliability and comparability between studies in order to facilitate future meta-analysis. Even if the pressure is difficult to measure, qualitative descriptions such as ‘harder than a brushstroke, but lighter than muscle massage’ would still be more valuable than no measure or description at all.
Assessing feasibility and piloting methods Our experience of evaluating TM is in line with the literature; the need for pilot testing in the same context that the study will be carried out cannot be stressed enough (Campbell et al., 2007; Mohler et al., 2012). ¨ Although this step is time-consuming and expensive, the long-term benefits are considerable. By sharing our experience of and reflection on our intervention, we hope to contribute to improvements in similar intervention studies in the future.
Reporting and evaluating a complex intervention A between–within design is appropriate to studies evaluating complex interventions. There are, however, some problems with using a randomized control trial design; for example, blinding. Several contextual factors might modulate the intervention effect (Blackwood, 2006). Nevertheless, randomized control is considered to be the most robust method to avoid selection bias (Craig et al., 2008). In our study the randomization procedure was not a problem, but the blinding was, for obvious reasons, impossible. As the initial STAI-Y score was lower for the TM group than for the control group, we may hypothesize that expectation of pleasure, comfort or relief may have an effect in addition to the effect of TM. Therefore, it would have been interesting to measure STAI-Y score after randomization, but before the participant had been informed of their group assignment. If the expectation effect had been of interest, the STAI-Y score could have been measured both before and after patients were informed of their group classification. Another major problem is the difficulty of recruiting enough participants for intervention studies. The choice seems to be between a small homogenous group with fewer confounders and a larger group given to increased variability and more confounding factors. It may be possible to find significant differences in some of the outcome parameters if the participant rate were increased. Nevertheless, a significant difference in STAI-Y score before and after TM was observed in the intervention group with a large effect size, indicating that the sample size for this outcome parameter was appropriate. Our study results and those of Henricson et al. (2008) showed no significant differences in stressrelated outcome parameters in patients cared for in ICU after receiving TM. This may be because of the fact that patients early in the post-operative phase or trauma phase have a high physiological stress response and their reduction in mental stress may be too small to actually affect their autonomic and endocrine response. For future studies evaluating the effects of massage, we suggest that measurements of mental parameters such as the STAI-Y should be used as primary outcome parameters. If stress-related outcome parameters are of interest, it is important also to adjust for the disease effect. Despite the low number of participants, there was a large effect on self-rated STAI-Y score after the participants received TM, indicating reduced anxiety. This has also been confirmed in other studies and may be explained by our previous functional magnetic resonance imaging results.
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CONCLUSION AND IMPLICATION FOR PRACTICE It is important to develop a theoretical basis for the study of TM’s efficacy in relieving physiological stress and self-reported anxiety. Different methodological approaches can be useful, and the MRC framework is a useful guideline for the development, evaluation and
reporting of complex nursing interventions such as TM. Results from this study revealed that TM can reduce anxiety. TM could therefore be a nursing intervention to use as an adjunct to conventional care and may help to minimize the use of medication and thus its side effects.
WHAT IS KNOWN ABOUT THIS TOPIC • Massage induces positive emotions in the receiver. • Models are lacking to explain observed responses during and after massage. • More research evaluating the design, methods and results of studies of intervention such as TM are necessary for the improvement of future interventions. WHAT THIS PAPER ADDS • • • •
TM can reduce anxiety levels in patients cared for in intensive and post-operative care. An example of the MRC framework applied to the development of massage studies. A proposal for better standardization of massage treatment in order to minimize confounders. A preliminary theoretical framework to explain responses during and after TM.
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