Stress Management in Patients Undergoing Carotid Endarterectomy for Carotid Artery Stenosis: A Pilot Randomized Controlled Trial Spyros N. Vasdekis,1,2,3,4 Andromachi Roussopoulou,3,4,5 Andreas Lazaris,1,2 Constantine N. Antonopoulos,1,2 Kostas Voumvourakis,5 Christina Darviri,3,4 and Georgios Tsivgoulis,5 Athens, Greece
Background: Psychological stress is common to patients submitted to cardiovascular operations. The purpose of this pilot, single-center, open-label, randomized controlled trial was to investigate the effects of a stress management program (SMP) on patients undergoing carotid endarterectomy (CEA). Methods: A sample of 24 patients with significant (>70%) carotid stenosis was finally randomized to SMP (intervention group; n ¼ 12) or no-stress management intervention (control group; n ¼ 12) before CEA. SMP consisted of 2 relaxation techniques (relaxation-breathing and guided imagery) before and 8 weeks after CEA. Measurements included Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS), Health Locus of Control Scale (HLC), and blood pressure and heart rate. Results: The 2 groups did not differ in terms of demographic characteristics, vascular risk factors, and baseline psychometric measurements. No delay on the time of surgery was caused by the practice of the relaxation techniques. Both perceived stress and anxiety improved within the intervention group at the end of the program (P ¼ 0.005 and P ¼ 0.007, respectively). No improvement in PSS-14, HLC, and HADS scores were documented in control group at the end of the 8-week follow-up period. The intervention group had lower PSS-14 scores at 8 weeks after CEA (median PSS-14 score, 20 points; range, 10e28) compared with control group (median PSS, 25 points; range, 11e47; P ¼ 0.026). No significant effect of SMP was found for blood pressure and heart rate measurements. Conclusions: Our results indicate that relaxation techniques appear to be beneficial in terms of stress and anxiety reduction in patients undergoing CEA. These findings require independent confirmation in the setting of a larger, double-blind randomized controlled trial.
Funding: This study received no funding. 1
Vascular Unit, 3rd Surgical Department, Athens University Medical School, Athens, Greece. 2 Department of Vascular Surgery, University of Athens Medical School, ‘‘Attikon’’ University Hospital, Athens, Greece. 3 Postgraduate Course in Stress Management and Health Promotion, University of Athens Medical School, Athens, Greece. 4
Biomedical Research Foundation, Academy of Athens, Athens, Greece.
5
Second Department of Neurology, University of Athens Medical School, ‘‘Attikon’’ University Hospital, Athens, Greece.
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Correspondence to: Spyros Vasdekis, MD, PhD, Vascular Unit, 3rd Department of Surgery, School of Medicine, University of Athens, University Hospital ‘Attikon,’ Rimini 1, Haidari, Athens, Greece; E-mail: [email protected] Ann Vasc Surg 2015; 29: 1400–1407 http://dx.doi.org/10.1016/j.avsg.2015.05.006 Ó 2015 Elsevier Inc. All rights reserved. Manuscript received: January 20, 2015; manuscript accepted: May 4, 2015; published online: June 30, 2015.
Vol. 29, No. 7, October 2015
INTRODUCTION The mainstay of treatment options for symptomatic carotid artery stenosis is focused around medical management, carotid endarterectomy (CEA), and carotid artery stenting (CAS). Among these, CEA has demonstrated greater safety and efficacy than best medical treatment in randomized controlled trials (RCTs) in the reduction of risk in ischemic stroke in symptomatic patients with carotid artery atherosclerosis.1,2 Surgical patients experience high levels of stress, anxiety, and depression and low sense of health control.3,4 Several recent studies indicated that preoperative stress and anxiety may have an impact on intraoperative cortisol and cardiovascular responses and on postoperative outcomes including frequency of complications, mental functioning, acute pain, use of analgesics, and worsening of preexisting anxiety and depression.5,6 Stress management programs have been implemented lately in surgical patients of different fields such as pediatric, general and cardiac surgery, obstetrics, and orthopedics with some promising results in clinical aspects (including sense of pain and analgesia consumption, wound healing, and duration of hospitalization) and in physiological parameters (such as blood pressure, heart rate, and hormonal concentrations of cortisol, oxytocin, and catecholamines).7,8 Coping with stress may be accomplished by several methods, of which the simplest and most easily administered are relaxation techniques such as relaxation breathing (RB), muscle progressive relaxation, guided imagery (GI), music therapy, and hypnosis.9 Several relaxation programs have been successfully applied in patients undergoing coronary artery bypass surgery in randomized controlled settings.10,11 These patients appear to share resemblances with patients undergoing carotid surgery in terms of preoperative and postoperative stress as well as vascular risk factors. However, no relevant study has been performed in patients undergoing CEA. The aim of this pilot, single-center, open-label RCT was to investigate the efficacy of 2 relaxation techniques between CEA patients, concerning reduction of stress, anxiety and depression symptoms, enhancement of self-control feeling, and normalization of physiological stress response.
METHODS Trial Design This was a 2-arm, open-label, RCT with a 1:1 allocation ratio of participants to stress-management
Stress management in patients after CEA 1401
intervention (intervention group) or no stressmanagement intervention (control group). Study Population The study was conducted at the Vascular Unit of the Third Department of Surgery in University Hospital ‘‘Attikon,’’ Athens, Greece. Patients were enrolled in the study between September 2011 and September 2012. Inclusion criteria are outlined in the following points: (1) Symptomatic or asymptomatic significant (70%) carotid artery stenosis scheduled for CEA (recommended first-line treatment) according to American Heart Association (AHA) recommendations1; (2) Symptomatic index event defined as nondisabling (modified Rankin Scale score [mRS] of 0e2) acute ischemic stroke or transient ischemic attack (TIA) according to AHA recommendations2; (3) Age >40 years; (4) Ability to read and write in Greek language. Exclusion criteria included history of previous CEA, history of previous disabling stroke (mRS score of >2), experiencing crescendo TIAs, active mental disease (e.g., dementia, major depression, and post-traumatic stress disorder), use of psychotropic drugs, and practice of other relaxation techniques (e.g., yoga, pilates, meditation, and psychotherapy). All patients with carotid stenosis were diagnosed using carotid duplex ultrasound according to the Society of Radiologists in Ultrasound Consensus Criteria.12 All the CEAs were performed by the either of the 2 participating vascular surgeons (S.V. and A.L.) under general anesthesia because of current anesthiosological practice in our hospital. We used eversion and primary closure techniques and no shunt, as previously described.13 All carotid operations for symptomatic patients were performed within 2 weeks of the index event, and no delay in the time of operation was caused by the application of relaxation techniques. Sociodemographic characteristics (age, gender, marital status, and education level), stroke risk factors including history of smoking, diabetes mellitus, hyperlipidemia, and hypertension, and symptomatic status of carotid stenosis were also recorded. Regular antihypertensive medication was stopped during hospitalization. However, in cases of hypertension, patients were treated with antihypertensive medication occasionally to preserve indicated blood pressure levels below 140/90 mm Hg, according to AHA
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guidelines.1 Based on our everyday experience, use of analgesia after CEA was particularly limited and occasional, so we did not record postoperative analgesic consumption in our study. The present study was approved by the Ethics Committee of our institution. All patients signed standard informed consent forms for CEA and were informed about potential periprocedural risks. Randomization and Blinding Patients who were considered eligible for study enrollment at their baseline assessment were randomly assigned to either the intervention or the control group, using random numbers generated by an online generator (www.random.org). Baseline and follow-up measurements of outcome measures were not blinded. Intervention Both the intervention and the control group were provided with identical written information concerning stress and its effects on health on their first evaluation for study enrollment. The stress management program included RB and GI. The above relaxation techniques were selected compared with others because of the ability of practicing them conveniently and directly, by elderly and immobile patients during hospitalization. The RB technique, which is believed to increase parasympathetic activity eliciting the experience of alertness and reinvigoration, was performed by taking deep diaphragmatic inspirations followed by slow prolonged expirations.14 GI is a mental function that expresses itself as a dynamic, quasi-real, psychophysiological process that engages all the senses to bring about individual changes in behavior, perception, or physiological responses.15 The GI technique (performed by appropriate audiovisual guide) included visualization by the patients of a relaxing image of a beach with themselves as part of it. Stress management is not part of our normal care, and this program was scheduled as part of a pilot study. During hospitalization, RB and GI were administered in the intervention group in form of a Moving Picture Experts Group 1 (MPEG-1) or MPEG-2 Audio Layer III (MP3) consisting of 5 min of RB, 10 min of GI, and 10 min of quiet background music. Training and explanation of the concept of stress management took place at the settings of our institution at the first day of enrollment to the program by a stress management experienced psychologist with a background in stress management focus groups after receiving the initial measurements (questionnaires and medical history). Teaching
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relaxation techniques caused no delay on the time of carotid surgery for the intervention group because all the patients exercised and got familiar with the techniques on the day of admission. This is an additional reason for picking out these comprehensive relaxation techniques, which are easily and quickly absorbed by the patients, after only a couple of repetitions. Patients were instructed to practice the guided relaxation techniques 3 times daily while hospitalized before CEA and twice a day for the following 8 weeks after carotid surgery. An audio compact disk (CD) with the exact content was also provided to all patients in the intervention group. Compliance to daily recommended sessions was encouraged by telephone communication at the end of each week and recorded by a self-reported checklist. During the telephone communication with the intervention patients, they were asked to report on their frequency of practicing with the audio CD, their mood, their sleep status, and their principal sources of stress during the last week, to increase compliance and reduce drop-outs. To provide consistency between the intervention and control groups and control for the ‘‘Hawthorn effect’’ the experienced health professional also provided patients in the control group with usual medical information about the CEA procedure, care instructions, risk factor modification, activity, and diet guidelines before and after surgery and telephoned the control patients at the end of every month. All patients were evaluated from an experienced neurologist before and after CEA. Outcome Measures Perceived Stress Scale. The Perceived Stress Scale (PSS) is a self-reported 14-item measure of the degree to which a situation in an individual’s life is appraised as stressful.16 For this purpose, responders rated the frequency of their feelings and thoughts over the previous month in a 5-point Likert-type scale (from 0 [never] to 4 [very often]). There were 7 positive and 7 negative items, whereas the total score was calculated by summing up each score after reversing all the positive items (minimum total score, 0; maximum total score, 56). Higher scores indicated higher level of perceived stress by the individual during the last month. The PSS-14 measurement was performed at the baseline evaluation and at the end of the 8-week follow-up period. Good psychometric properties of this measure within the Greek population have been previously recorded.17 Hospital Anxiety Depression Scale. The Hospital Anxiety Depression Scale (HADS) is a self-reported 14-item measure of anxiety and depression
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(7 questions for the subscale of anxiety and 7 questions for the subscale of depression).18 This instrument has been previously standardized for Greek individuals with satisfactory internal consistency (Cronbach alpha ¼ 0.884) and validity (testeretest intraclass correlation coefficient, 0.944).19 Respondents rated their frequency of feelings and thoughts over the previous week in a 4-point Likert-type scale (from never and/or not a bit to very often and/or definitely) with a total score ranging between 0 and 42 (0e21 for each subscale). Health Locus of Control Scale. The Health Locus of Control Scale (HLC) was measured using the 18item instrument developed by Wallston et al.20 This instrument has been previously validated in the Greek population with satisfactory internal consistency.21 Responders expressed their level of agreement to 18 statements in a 6-point Likerttype scale (from 1 [strongly disagree] to 6 [strongly agree]). The scale was built on three 6-item subscales, namely ‘‘internal HLC’’ (HLC1), ‘‘external HLC’’ (HLC2), and ‘‘chance HLC’’ (HLC3). The HLC1 measured the degree in which the individual believed that he or she is responsible for his or her health status. The HLC2 and HLC3 represented the extent in which other people (such as medical doctors) or chance, respectively, were perceived by individuals as the main health determinants. After summing up answers for each subscale, higher scores indicate higher strength of each type of health belief (total score ranges from 6 to 36 for each subscale). HLC measurements were performed at baseline and at the end of the 8-week follow-up period. Blood pressure and heart rate. Blood pressure and heart rate measurements were performed at baseline assessment, during hospitalization and at the end of the 8-week follow-up period using automated oscillometric recordings. Statistical Methods Because this was the first RCT evaluating this research question, we selected a sample size of 28 patients (14 patients per allocation group) in line with the methodology of existing small RCTs evaluating the feasibility and efficacy of stress management in patients undergoing cardiac surgery.11 Baseline characteristics are presented as percentages for noncontinuous variables and as medians with corresponding ranges for continuous variables. Statistical comparisons between intervention and control group for outcome measures (Likert scale data analysis) were performed after excluding drop-outs (patients who eventually refused to undergo CEA, patients who withdrew informed consent, and patients who
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discontinued stress management program) using Fisher’s exact test, ManneWhitney U test, and Wilcoxon test, as appropriate. Additional correlational analyses were performed using Spearman’s rho (r) coefficient. The P value of significance was set at 0.05 for all analyses. Statistical calculations were performed using the SPSS for Windows (version 20) statistical software (SPSS Inc., Chicago, IL).
RESULTS A total of 38 patients were assessed as potential candidates for inclusion in the trial during the recruitment period. Ten patients did not fulfill inclusion criteria and were excluded from participation: 1 patient was 0.05) in terms of baseline characteristics. We did not record differences in days of hospitalization, duration of operation, and clamp time between cases and controls. A complete neurologic evaluation by an experienced neurologist evidenced no postoperative surgical complications in both groups, considering aspects such as cranial nerve injury. All patients left the operating room with a Redon drainage bottle, which was removed the first postoperative day. We did not record neck hematoma requiring further surgery, drainage, transfusion or extended hospitalization, cardiac events, or death. As a result, neurologic and cardiovascular events in our study sample were 0 in a 2-month follow-up period.
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Fig. 1. Trial flow chart.
Table I. Baseline characteristics of the study population Baseline characteristic
Intervention group (n ¼ 12)
Control group (n ¼ 12)
P valuea
Median age (range), years Men (%) Married (%) Median education years (range) Symptomatic carotid artery stenosis (%) Current or past smoker (%) Hypertension (%) Diabetes (%) Hypercholesterolemia (%) Median PSS-14 score (range) Median HLC1 score (range) Median HLC2 score (range) Median HLC3 score (range) Median HADS Anxiety score (range) Median HADS Depression score (range) Median SBP (range) Median DBP (range) Median HR (range)
70 9 8 12 8 8 11 4 8 24 26 21 29 7 9.5 126 72 72
69 10 7 8 5 9 11 4 9 26 30.5 22 30 5 5.5 127 64 67
0.707 0.999 0.408 0.081 0.414 0.999 0.999 0.999 0.999 0.908 0.051 0.817 0.483 0.139 0.066 0.371 0.092 0.236
(53e85) (75) (67) (6e16) (66) (66) (92) (33) (67) (13e37) (20e28) (6e32) (25e36) (2e17) (2e16) (93e142) (60e81) (50e102)
(45e77) (83) (58) (6e12) (42) (75) (92) (33) (75) (14e51) (20e36) (6e28) (22e34) (1e19) (3e12) (104e171) (50e110) (43e81)
SBP, systolic blood pressure; DBP, diastolic blood pressure; HR, heart rate. a ManneWhitney test, Fisher’s exact test.
Out of our experience, use of analgesia after surgery was particularly limited, so we did not record postoperative consumption in our study. Tables II and III show the main results of the outcome analyses. Both perceived stress (assessed
by the PSS-14 score) and anxiety (assessed by HADS anxiety scale) improved within the intervention group at the end of the program (P ¼ 0.005 and P ¼ 0.007, respectively; Table II). Significant improvements were also noted in HLC1 and HLC2
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Table II. Within- and between-group comparisons for study outcomes Intervention group (n ¼ 12)
Between-group comparisonsa
Control group (n ¼ 12)
Psychometric test
Preoperative Postoperative P value Preoperative Postoperative P value P value
PSS-14 (median, range) HLC1 (median, range) HLC2 (median, range) HLC3 (median, range) HADS anxiety (median, range) HADS depression (median, range)
24 26 21 29 7 10
a
(13e37) (20e28) (6e32) (25e36) (2e17) (2e16)
20 27 17 33 6 8
(10e28) (23e34) (6e31) (19e36) (1e11) (0e15)
0.005 0.032 0.016 0.055 0.007 0.096
26 31 22 30 5 6
(14e51) (20e36) (6e28) (22e34) (1e19) (3e12)
25 29 22 32 6 6
(11e47) (19e35) (7e29) (25e36) (2e18) (2e11)
0.554 0.174 0.999 0.070 0.633 0.345
0.026 0.311 0.298 0.562 0.862 0.385
Postoperative comparisons.
Table III. Within- and between-group comparisons for blood pressure and heart rate Intervention group (n ¼ 12) Parameter
Preoperative
Postoperative
Between-group comparisonsa
Control group (n ¼ 12) P value Preoperative
SBP, mm Hg 125 (101e144) 124 (114e135) 0.814 (median, range) DBP, mm Hg 72 (62e86) 65 (60e77) 0.117 (median, range) HR 67 (53e104) 72 (61e95) 0.433
Postoperative
P value P value
126 (104e169) 130 (100e178) 0.875
0.299
61 (54e98)
64 (56e103)
0.136
0.525
63 (45e82)
71 (50e85)
0.117
0.386
SBP, systolic blood pressure; DBP, diastolic blood pressure; HR, heart rate. a Postoperative comparisons.
measurements within the intervention group (P < 0.05). No improvement in PSS-14, HLC, and HADS scores were documented in control group at the end of the 8-week follow-up period. The intervention group had lower PSS-14 scores at 8 weeks after CEA (median PSS-14 score, 20 points; range, 10e28) compared with control group (median PSS, 25 points; range, 11e47; P ¼ 0.026). No significant effect of stress management was found for blood pressure and heart rate recordings in the intervention group (Table III). Similarly, no changes were noted between baseline and followup recordings in the control group. Additional analyses indicated a linear and positive correlation between the improvement in perceived stress (quantified by changes in PSS-14 score) and the improvement in perceived anxiety (quantified by changes in HADS anxiety scale) in the intervention group (Spearman r ¼ 0.695; P ¼ 0.007).
DISCUSSION To the best of our knowledge, this was the first, open-label, RCT that evaluated the feasibility and efficacy of stress management programs in a small sample of patients undergoing CEA. Our preliminary data indicated that relaxation techniques may be of potential benefit to patients scheduled to
undergo CEA for asymptomatic or symptomatic carotid artery stenosis. Interestingly, similar promising results have been shown with stress management in pilot RCTs evaluating patients undergoing coronary artery bypass surgery.10,11,22 Given the fact that patients undergoing CEA share common features with patients undergoing coronary surgery (including similar clinical profile, risk factors, and severity of procedure) we hypothesized that stress management may prove beneficial to our study population as well. Indeed, our findings lend support to the current literature underlining that stress management programs may attenuate stress, anxiety, and pain after different surgical procedures.8e 11,22,23 In this pilot study, our sample size was rather small to subdivide and separately process symptomatic and asymptomatic patients. Although inclusion of both symptomatic and asymptomatic patients may be a confounder, because patient with symptomatic disease will have more stress compared with asymptomatic patients, we did not record difference in symptomatic status between cases and controls. The potential impact of stress management program on perceived levels of anxiety is intriguing. From a neuroendocrine perspective, GI helps downregulate the hypothalamicepituitaryeadrenal axis,
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which may in turn result in decreased glucocorticoid and catecholamine levels.7 From the perspective of the autonomic nervous system, there is an interactive relationship between the sympathetic and parasympathetic system that occurs in response to stimuli, whether real or imagined.14 Furthermore, RB is believed to increase parasympathetic activity that results in alertness and anxiety attenuation.14 There is an ongoing controversy regarding the optimal treatment for carotid artery stenosis because CAS has lately emerged as a less invasive alternative to CEA. However, CEA remains the first-line recommended treatment of symptomatic disease.1,2,24 Health-related quality of life (HRQL) is an aspect that is frequently measured after interventions for carotid artery disease. Prior studies suggest that CAS is associated with better HQRL during the early recovery period, especially considering physical limitations and sense of pain.25,26 These differences, however, become less pronounced after the first month of follow-up and are no longer present after the first year.25,26 Therefore a concentrated preoperaive and postoperative stress management program during the crucial period of 8 weeks after carotid surgery may drastically ameliorate HRQL in patients undergoing CEA. Certain limitations of the present study need to be acknowledged. First, our sample size was small and type II statistical errors cannot be excluded. As a result, we could not proceed to subgroup analysis for symptomatic and asymptomatic patients because of high potential for misleading results. Further confirmation of the results through a larger RCT is needed because of differences in profile and prognosis of symptomatic patients. Second, it should be noted that the reliability of our study findings heavily depends on the cooperation and frankness of enrolled patients. Furthermore, concerns remain about the evaluation of stress reduction in patients submitted to CEA under general anesthesia. Both groups, cases and controls, received general anesthesia, and as a result, its effect on postoperative stress reduction could not be evaluated. This limitation may guide future research practice to explore the potential differences in stress reduction between CEA under general and locoregional anesthesia. Third, the study was open label, and this may have affected the validity of the reported findings. Finally, the used set of strict inclusion and exclusion criteria may undermine the generalizability of our observations. In conclusion, the results of this pilot, open-label, RCT provide first-ever evidence that relaxation techniques may be an effective method of preparing patients undergoing CEA in terms of stress and
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anxiety reduction. Our findings require independent confirmation in the setting of a larger, double-blind RCT. Relaxation techniques aim to reinforce skills and knowledge for managing stressful events after discharge from hospital. Considering also their low cost, they could be easily further supported in everyday clinical practice. Measurements of biological markers such as catecholamines, cortisol, or oxytocin might also be beneficial to assess the adequacy of relaxation techniques on stress and anxiety reduction in patients undergoing CEA. REFERENCES 1. Furie KL, Kasner SE, Adams RJ, et al. Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2011;42:227e76. 2. Chaturvedi S, Bruno A, Feasby T, et al. Carotid endarterectomyean evidence-based review: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2005;65:794e801. 3. Carr EC, Nicky Thomas V, Wilson-Barnet J. Patient experiences of anxiety, depression and acute pain after surgery: a longitudinal perspective. Int J Nurs Stud 2005;42:521e30. 4. Gallagher R, McKinley S. Anxiety, depression and perceived control in patients having coronary artery bypass grafts. J Adv Nurs 2009;65:2386e96. 5. Pearson S, Maddern GJ, Fitridge R. The role of pre-operative state-anxiety in the determination of intra-operative neuroendocrine responses and recovery. Br J Health Psychol 2005;10(Pt 2):299e310. 6. Schelling G, Richter M, Roozendaal B, et al. Exposure to high stress in the intensive care unit may have negative effects on health-related quality-of-life outcomes after cardiac surgery. Crit Care Med 2003;31:1971e80. 7. Manyande A, Berg S, Gettins D, et al. Preoperative rehearsal of active coping imagery influences subjective and hormonal responses to abdominal surgery. Psychosom Med 1995;57: 177e82. 8. Broadbent E, Kahokehr A, Booth RJ, et al. A brief relaxation intervention reduces stress and improves surgical wound healing response: a randomised trial. Brain Behav Immun 2012;26:212e7. 9. Kshettry VR, Carole LF, Henly SJ, et al. Complementary alternative medical therapies for heart surgery patients: feasibility, safety, and impact. Ann Thorac Surg 2006;81: 201e5. 10. Nilsson U. Soothing music can increase oxytocin levels during bed rest after open-heart surgery: a randomised control trial. J Clin Nurs 2009;18:2153e61. 11. Nilsson U. The effect of music intervention in stress response to cardiac surgery in a randomized clinical trial. Heart Lung 2009;38:201e7. 12. Grant EG, Benson CB, Moneta GL, et al. Carotid artery stenosis: gray-scale and Doppler US diagnosiseSociety of Radiologists in Ultrasound Consensus Conference. Radiology 2003;229:340e6. 13. Lazaris AM, Vasdekis SN, Gougoulakis AG, et al. Assessment of voice quality after carotid endarterectomy. Eur J Vasc Endovasc Surg 2002;24:344e8.
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14. Jerath R, Edry JW, Barnes VA, Jerath V. Physiology of long pranayamic breathing: neural respiratory elements may provide a mechanism that explains how slow deep breathing shifts the autonomic nervous system. Med Hypotheses 2006;67:566e71. 15. Cohen L, Parker PA, Vence L, et al. Presurgical stress management improves postoperative immune function in men with prostate cancer undergoing radical prostatectomy. Psychosom Med 2011;73:218e25. 16. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav 1983;24:385e96. 17. Andreou E, Alexopoulos EC, Lionis C, et al. Perceived Stress Scale: reliability and validity study in Greece. Int J Environ Res Public Health 2011;8:3287e98. 18. Pritchard MJ. Using the hospital anxiety and depression scale in surgical patients. Nurs Stand 2011;25:35e41. 19. Christodoulou C, Michopoulos J, Tournikioti K, et al. Hospital anxiety and depression scale. A quantitative analysis in medical outpatients, psychiatric outpatients and normal subjects. Psychiatriki 2010;21:279e86. 20. Wallston KA, Wallston BS, DeVellis R. Development of the Multidimensional Health Locus of Control (MHLC) Scales. Health Educ Monogr 1978;6:160e70.
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21. Karademas EC. Effects of exposure to the suffering of unknown persons on health-related cognitions, and the role of mood. Health 2009;13:491e504. 22. Orth-Gomer K, Schneiderman N, Wang HX, et al. Stress reduction prolongs life in women with coronary disease: the Stockholm Women’s Intervention Trial for Coronary Heart Disease (SWITCHD). Circ Cardiovasc Qual Outcomes 2009;2:25e32. 23. Bernatzky G, Presch M, Anderson M, Panksepp J. Emotional foundations of music as a non-pharmacological pain management tool in modern medicine. Neurosci Biobehav Rev 2011;35:1989e99. 24. Roffi M, Mukherjee D, Clair DG. Carotid artery stenting vs. endarterectomy. Eur Heart J 2009;30:2693e704. 25. Cohen DJ, Stolker JM, Wang K, et al. Health-related quality of life after carotid stenting versus carotid endarterectomy: results from CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial). J Am Coll Cardiol 2011;58:1557e65. 26. Stolker JM, Mahoney EM, Safley DM, et al. Health-related quality of life following carotid stenting versus endarterectomy: results from the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at HIgh Risk for Endarterectomy) trial. JACC Cardiovasc Interv 2010;3:515e23.
Background: Psychological stress is common to patients submitted to cardiovascular operations. The purpose of this pilot, single-center, open-label, randomized controlled trial was to investigate the effects of a stress management program (SMP) on patients undergoing carotid endarterectomy (CEA). Methods: A sample of 24 patients with significant (>70%) carotid stenosis was finally randomized to SMP (intervention group; n ¼ 12) or no-stress management intervention (control group; n ¼ 12) before CEA. SMP consisted of 2 relaxation techniques (relaxation-breathing and guided imagery) before and 8 weeks after CEA. Measurements included Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS), Health Locus of Control Scale (HLC), and blood pressure and heart rate. Results: The 2 groups did not differ in terms of demographic characteristics, vascular risk factors, and baseline psychometric measurements. No delay on the time of surgery was caused by the practice of the relaxation techniques. Both perceived stress and anxiety improved within the intervention group at the end of the program (P ¼ 0.005 and P ¼ 0.007, respectively). No improvement in PSS-14, HLC, and HADS scores were documented in control group at the end of the 8-week follow-up period. The intervention group had lower PSS-14 scores at 8 weeks after CEA (median PSS-14 score, 20 points; range, 10e28) compared with control group (median PSS, 25 points; range, 11e47; P ¼ 0.026). No significant effect of SMP was found for blood pressure and heart rate measurements. Conclusions: Our results indicate that relaxation techniques appear to be beneficial in terms of stress and anxiety reduction in patients undergoing CEA. These findings require independent confirmation in the setting of a larger, double-blind randomized controlled trial.
Funding: This study received no funding. 1
Vascular Unit, 3rd Surgical Department, Athens University Medical School, Athens, Greece. 2 Department of Vascular Surgery, University of Athens Medical School, ‘‘Attikon’’ University Hospital, Athens, Greece. 3 Postgraduate Course in Stress Management and Health Promotion, University of Athens Medical School, Athens, Greece. 4
Biomedical Research Foundation, Academy of Athens, Athens, Greece.
5
Second Department of Neurology, University of Athens Medical School, ‘‘Attikon’’ University Hospital, Athens, Greece.
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Correspondence to: Spyros Vasdekis, MD, PhD, Vascular Unit, 3rd Department of Surgery, School of Medicine, University of Athens, University Hospital ‘Attikon,’ Rimini 1, Haidari, Athens, Greece; E-mail: [email protected] Ann Vasc Surg 2015; 29: 1400–1407 http://dx.doi.org/10.1016/j.avsg.2015.05.006 Ó 2015 Elsevier Inc. All rights reserved. Manuscript received: January 20, 2015; manuscript accepted: May 4, 2015; published online: June 30, 2015.
Vol. 29, No. 7, October 2015
INTRODUCTION The mainstay of treatment options for symptomatic carotid artery stenosis is focused around medical management, carotid endarterectomy (CEA), and carotid artery stenting (CAS). Among these, CEA has demonstrated greater safety and efficacy than best medical treatment in randomized controlled trials (RCTs) in the reduction of risk in ischemic stroke in symptomatic patients with carotid artery atherosclerosis.1,2 Surgical patients experience high levels of stress, anxiety, and depression and low sense of health control.3,4 Several recent studies indicated that preoperative stress and anxiety may have an impact on intraoperative cortisol and cardiovascular responses and on postoperative outcomes including frequency of complications, mental functioning, acute pain, use of analgesics, and worsening of preexisting anxiety and depression.5,6 Stress management programs have been implemented lately in surgical patients of different fields such as pediatric, general and cardiac surgery, obstetrics, and orthopedics with some promising results in clinical aspects (including sense of pain and analgesia consumption, wound healing, and duration of hospitalization) and in physiological parameters (such as blood pressure, heart rate, and hormonal concentrations of cortisol, oxytocin, and catecholamines).7,8 Coping with stress may be accomplished by several methods, of which the simplest and most easily administered are relaxation techniques such as relaxation breathing (RB), muscle progressive relaxation, guided imagery (GI), music therapy, and hypnosis.9 Several relaxation programs have been successfully applied in patients undergoing coronary artery bypass surgery in randomized controlled settings.10,11 These patients appear to share resemblances with patients undergoing carotid surgery in terms of preoperative and postoperative stress as well as vascular risk factors. However, no relevant study has been performed in patients undergoing CEA. The aim of this pilot, single-center, open-label RCT was to investigate the efficacy of 2 relaxation techniques between CEA patients, concerning reduction of stress, anxiety and depression symptoms, enhancement of self-control feeling, and normalization of physiological stress response.
METHODS Trial Design This was a 2-arm, open-label, RCT with a 1:1 allocation ratio of participants to stress-management
Stress management in patients after CEA 1401
intervention (intervention group) or no stressmanagement intervention (control group). Study Population The study was conducted at the Vascular Unit of the Third Department of Surgery in University Hospital ‘‘Attikon,’’ Athens, Greece. Patients were enrolled in the study between September 2011 and September 2012. Inclusion criteria are outlined in the following points: (1) Symptomatic or asymptomatic significant (70%) carotid artery stenosis scheduled for CEA (recommended first-line treatment) according to American Heart Association (AHA) recommendations1; (2) Symptomatic index event defined as nondisabling (modified Rankin Scale score [mRS] of 0e2) acute ischemic stroke or transient ischemic attack (TIA) according to AHA recommendations2; (3) Age >40 years; (4) Ability to read and write in Greek language. Exclusion criteria included history of previous CEA, history of previous disabling stroke (mRS score of >2), experiencing crescendo TIAs, active mental disease (e.g., dementia, major depression, and post-traumatic stress disorder), use of psychotropic drugs, and practice of other relaxation techniques (e.g., yoga, pilates, meditation, and psychotherapy). All patients with carotid stenosis were diagnosed using carotid duplex ultrasound according to the Society of Radiologists in Ultrasound Consensus Criteria.12 All the CEAs were performed by the either of the 2 participating vascular surgeons (S.V. and A.L.) under general anesthesia because of current anesthiosological practice in our hospital. We used eversion and primary closure techniques and no shunt, as previously described.13 All carotid operations for symptomatic patients were performed within 2 weeks of the index event, and no delay in the time of operation was caused by the application of relaxation techniques. Sociodemographic characteristics (age, gender, marital status, and education level), stroke risk factors including history of smoking, diabetes mellitus, hyperlipidemia, and hypertension, and symptomatic status of carotid stenosis were also recorded. Regular antihypertensive medication was stopped during hospitalization. However, in cases of hypertension, patients were treated with antihypertensive medication occasionally to preserve indicated blood pressure levels below 140/90 mm Hg, according to AHA
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guidelines.1 Based on our everyday experience, use of analgesia after CEA was particularly limited and occasional, so we did not record postoperative analgesic consumption in our study. The present study was approved by the Ethics Committee of our institution. All patients signed standard informed consent forms for CEA and were informed about potential periprocedural risks. Randomization and Blinding Patients who were considered eligible for study enrollment at their baseline assessment were randomly assigned to either the intervention or the control group, using random numbers generated by an online generator (www.random.org). Baseline and follow-up measurements of outcome measures were not blinded. Intervention Both the intervention and the control group were provided with identical written information concerning stress and its effects on health on their first evaluation for study enrollment. The stress management program included RB and GI. The above relaxation techniques were selected compared with others because of the ability of practicing them conveniently and directly, by elderly and immobile patients during hospitalization. The RB technique, which is believed to increase parasympathetic activity eliciting the experience of alertness and reinvigoration, was performed by taking deep diaphragmatic inspirations followed by slow prolonged expirations.14 GI is a mental function that expresses itself as a dynamic, quasi-real, psychophysiological process that engages all the senses to bring about individual changes in behavior, perception, or physiological responses.15 The GI technique (performed by appropriate audiovisual guide) included visualization by the patients of a relaxing image of a beach with themselves as part of it. Stress management is not part of our normal care, and this program was scheduled as part of a pilot study. During hospitalization, RB and GI were administered in the intervention group in form of a Moving Picture Experts Group 1 (MPEG-1) or MPEG-2 Audio Layer III (MP3) consisting of 5 min of RB, 10 min of GI, and 10 min of quiet background music. Training and explanation of the concept of stress management took place at the settings of our institution at the first day of enrollment to the program by a stress management experienced psychologist with a background in stress management focus groups after receiving the initial measurements (questionnaires and medical history). Teaching
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relaxation techniques caused no delay on the time of carotid surgery for the intervention group because all the patients exercised and got familiar with the techniques on the day of admission. This is an additional reason for picking out these comprehensive relaxation techniques, which are easily and quickly absorbed by the patients, after only a couple of repetitions. Patients were instructed to practice the guided relaxation techniques 3 times daily while hospitalized before CEA and twice a day for the following 8 weeks after carotid surgery. An audio compact disk (CD) with the exact content was also provided to all patients in the intervention group. Compliance to daily recommended sessions was encouraged by telephone communication at the end of each week and recorded by a self-reported checklist. During the telephone communication with the intervention patients, they were asked to report on their frequency of practicing with the audio CD, their mood, their sleep status, and their principal sources of stress during the last week, to increase compliance and reduce drop-outs. To provide consistency between the intervention and control groups and control for the ‘‘Hawthorn effect’’ the experienced health professional also provided patients in the control group with usual medical information about the CEA procedure, care instructions, risk factor modification, activity, and diet guidelines before and after surgery and telephoned the control patients at the end of every month. All patients were evaluated from an experienced neurologist before and after CEA. Outcome Measures Perceived Stress Scale. The Perceived Stress Scale (PSS) is a self-reported 14-item measure of the degree to which a situation in an individual’s life is appraised as stressful.16 For this purpose, responders rated the frequency of their feelings and thoughts over the previous month in a 5-point Likert-type scale (from 0 [never] to 4 [very often]). There were 7 positive and 7 negative items, whereas the total score was calculated by summing up each score after reversing all the positive items (minimum total score, 0; maximum total score, 56). Higher scores indicated higher level of perceived stress by the individual during the last month. The PSS-14 measurement was performed at the baseline evaluation and at the end of the 8-week follow-up period. Good psychometric properties of this measure within the Greek population have been previously recorded.17 Hospital Anxiety Depression Scale. The Hospital Anxiety Depression Scale (HADS) is a self-reported 14-item measure of anxiety and depression
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(7 questions for the subscale of anxiety and 7 questions for the subscale of depression).18 This instrument has been previously standardized for Greek individuals with satisfactory internal consistency (Cronbach alpha ¼ 0.884) and validity (testeretest intraclass correlation coefficient, 0.944).19 Respondents rated their frequency of feelings and thoughts over the previous week in a 4-point Likert-type scale (from never and/or not a bit to very often and/or definitely) with a total score ranging between 0 and 42 (0e21 for each subscale). Health Locus of Control Scale. The Health Locus of Control Scale (HLC) was measured using the 18item instrument developed by Wallston et al.20 This instrument has been previously validated in the Greek population with satisfactory internal consistency.21 Responders expressed their level of agreement to 18 statements in a 6-point Likerttype scale (from 1 [strongly disagree] to 6 [strongly agree]). The scale was built on three 6-item subscales, namely ‘‘internal HLC’’ (HLC1), ‘‘external HLC’’ (HLC2), and ‘‘chance HLC’’ (HLC3). The HLC1 measured the degree in which the individual believed that he or she is responsible for his or her health status. The HLC2 and HLC3 represented the extent in which other people (such as medical doctors) or chance, respectively, were perceived by individuals as the main health determinants. After summing up answers for each subscale, higher scores indicate higher strength of each type of health belief (total score ranges from 6 to 36 for each subscale). HLC measurements were performed at baseline and at the end of the 8-week follow-up period. Blood pressure and heart rate. Blood pressure and heart rate measurements were performed at baseline assessment, during hospitalization and at the end of the 8-week follow-up period using automated oscillometric recordings. Statistical Methods Because this was the first RCT evaluating this research question, we selected a sample size of 28 patients (14 patients per allocation group) in line with the methodology of existing small RCTs evaluating the feasibility and efficacy of stress management in patients undergoing cardiac surgery.11 Baseline characteristics are presented as percentages for noncontinuous variables and as medians with corresponding ranges for continuous variables. Statistical comparisons between intervention and control group for outcome measures (Likert scale data analysis) were performed after excluding drop-outs (patients who eventually refused to undergo CEA, patients who withdrew informed consent, and patients who
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discontinued stress management program) using Fisher’s exact test, ManneWhitney U test, and Wilcoxon test, as appropriate. Additional correlational analyses were performed using Spearman’s rho (r) coefficient. The P value of significance was set at 0.05 for all analyses. Statistical calculations were performed using the SPSS for Windows (version 20) statistical software (SPSS Inc., Chicago, IL).
RESULTS A total of 38 patients were assessed as potential candidates for inclusion in the trial during the recruitment period. Ten patients did not fulfill inclusion criteria and were excluded from participation: 1 patient was 0.05) in terms of baseline characteristics. We did not record differences in days of hospitalization, duration of operation, and clamp time between cases and controls. A complete neurologic evaluation by an experienced neurologist evidenced no postoperative surgical complications in both groups, considering aspects such as cranial nerve injury. All patients left the operating room with a Redon drainage bottle, which was removed the first postoperative day. We did not record neck hematoma requiring further surgery, drainage, transfusion or extended hospitalization, cardiac events, or death. As a result, neurologic and cardiovascular events in our study sample were 0 in a 2-month follow-up period.
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Fig. 1. Trial flow chart.
Table I. Baseline characteristics of the study population Baseline characteristic
Intervention group (n ¼ 12)
Control group (n ¼ 12)
P valuea
Median age (range), years Men (%) Married (%) Median education years (range) Symptomatic carotid artery stenosis (%) Current or past smoker (%) Hypertension (%) Diabetes (%) Hypercholesterolemia (%) Median PSS-14 score (range) Median HLC1 score (range) Median HLC2 score (range) Median HLC3 score (range) Median HADS Anxiety score (range) Median HADS Depression score (range) Median SBP (range) Median DBP (range) Median HR (range)
70 9 8 12 8 8 11 4 8 24 26 21 29 7 9.5 126 72 72
69 10 7 8 5 9 11 4 9 26 30.5 22 30 5 5.5 127 64 67
0.707 0.999 0.408 0.081 0.414 0.999 0.999 0.999 0.999 0.908 0.051 0.817 0.483 0.139 0.066 0.371 0.092 0.236
(53e85) (75) (67) (6e16) (66) (66) (92) (33) (67) (13e37) (20e28) (6e32) (25e36) (2e17) (2e16) (93e142) (60e81) (50e102)
(45e77) (83) (58) (6e12) (42) (75) (92) (33) (75) (14e51) (20e36) (6e28) (22e34) (1e19) (3e12) (104e171) (50e110) (43e81)
SBP, systolic blood pressure; DBP, diastolic blood pressure; HR, heart rate. a ManneWhitney test, Fisher’s exact test.
Out of our experience, use of analgesia after surgery was particularly limited, so we did not record postoperative consumption in our study. Tables II and III show the main results of the outcome analyses. Both perceived stress (assessed
by the PSS-14 score) and anxiety (assessed by HADS anxiety scale) improved within the intervention group at the end of the program (P ¼ 0.005 and P ¼ 0.007, respectively; Table II). Significant improvements were also noted in HLC1 and HLC2
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Table II. Within- and between-group comparisons for study outcomes Intervention group (n ¼ 12)
Between-group comparisonsa
Control group (n ¼ 12)
Psychometric test
Preoperative Postoperative P value Preoperative Postoperative P value P value
PSS-14 (median, range) HLC1 (median, range) HLC2 (median, range) HLC3 (median, range) HADS anxiety (median, range) HADS depression (median, range)
24 26 21 29 7 10
a
(13e37) (20e28) (6e32) (25e36) (2e17) (2e16)
20 27 17 33 6 8
(10e28) (23e34) (6e31) (19e36) (1e11) (0e15)
0.005 0.032 0.016 0.055 0.007 0.096
26 31 22 30 5 6
(14e51) (20e36) (6e28) (22e34) (1e19) (3e12)
25 29 22 32 6 6
(11e47) (19e35) (7e29) (25e36) (2e18) (2e11)
0.554 0.174 0.999 0.070 0.633 0.345
0.026 0.311 0.298 0.562 0.862 0.385
Postoperative comparisons.
Table III. Within- and between-group comparisons for blood pressure and heart rate Intervention group (n ¼ 12) Parameter
Preoperative
Postoperative
Between-group comparisonsa
Control group (n ¼ 12) P value Preoperative
SBP, mm Hg 125 (101e144) 124 (114e135) 0.814 (median, range) DBP, mm Hg 72 (62e86) 65 (60e77) 0.117 (median, range) HR 67 (53e104) 72 (61e95) 0.433
Postoperative
P value P value
126 (104e169) 130 (100e178) 0.875
0.299
61 (54e98)
64 (56e103)
0.136
0.525
63 (45e82)
71 (50e85)
0.117
0.386
SBP, systolic blood pressure; DBP, diastolic blood pressure; HR, heart rate. a Postoperative comparisons.
measurements within the intervention group (P < 0.05). No improvement in PSS-14, HLC, and HADS scores were documented in control group at the end of the 8-week follow-up period. The intervention group had lower PSS-14 scores at 8 weeks after CEA (median PSS-14 score, 20 points; range, 10e28) compared with control group (median PSS, 25 points; range, 11e47; P ¼ 0.026). No significant effect of stress management was found for blood pressure and heart rate recordings in the intervention group (Table III). Similarly, no changes were noted between baseline and followup recordings in the control group. Additional analyses indicated a linear and positive correlation between the improvement in perceived stress (quantified by changes in PSS-14 score) and the improvement in perceived anxiety (quantified by changes in HADS anxiety scale) in the intervention group (Spearman r ¼ 0.695; P ¼ 0.007).
DISCUSSION To the best of our knowledge, this was the first, open-label, RCT that evaluated the feasibility and efficacy of stress management programs in a small sample of patients undergoing CEA. Our preliminary data indicated that relaxation techniques may be of potential benefit to patients scheduled to
undergo CEA for asymptomatic or symptomatic carotid artery stenosis. Interestingly, similar promising results have been shown with stress management in pilot RCTs evaluating patients undergoing coronary artery bypass surgery.10,11,22 Given the fact that patients undergoing CEA share common features with patients undergoing coronary surgery (including similar clinical profile, risk factors, and severity of procedure) we hypothesized that stress management may prove beneficial to our study population as well. Indeed, our findings lend support to the current literature underlining that stress management programs may attenuate stress, anxiety, and pain after different surgical procedures.8e 11,22,23 In this pilot study, our sample size was rather small to subdivide and separately process symptomatic and asymptomatic patients. Although inclusion of both symptomatic and asymptomatic patients may be a confounder, because patient with symptomatic disease will have more stress compared with asymptomatic patients, we did not record difference in symptomatic status between cases and controls. The potential impact of stress management program on perceived levels of anxiety is intriguing. From a neuroendocrine perspective, GI helps downregulate the hypothalamicepituitaryeadrenal axis,
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which may in turn result in decreased glucocorticoid and catecholamine levels.7 From the perspective of the autonomic nervous system, there is an interactive relationship between the sympathetic and parasympathetic system that occurs in response to stimuli, whether real or imagined.14 Furthermore, RB is believed to increase parasympathetic activity that results in alertness and anxiety attenuation.14 There is an ongoing controversy regarding the optimal treatment for carotid artery stenosis because CAS has lately emerged as a less invasive alternative to CEA. However, CEA remains the first-line recommended treatment of symptomatic disease.1,2,24 Health-related quality of life (HRQL) is an aspect that is frequently measured after interventions for carotid artery disease. Prior studies suggest that CAS is associated with better HQRL during the early recovery period, especially considering physical limitations and sense of pain.25,26 These differences, however, become less pronounced after the first month of follow-up and are no longer present after the first year.25,26 Therefore a concentrated preoperaive and postoperative stress management program during the crucial period of 8 weeks after carotid surgery may drastically ameliorate HRQL in patients undergoing CEA. Certain limitations of the present study need to be acknowledged. First, our sample size was small and type II statistical errors cannot be excluded. As a result, we could not proceed to subgroup analysis for symptomatic and asymptomatic patients because of high potential for misleading results. Further confirmation of the results through a larger RCT is needed because of differences in profile and prognosis of symptomatic patients. Second, it should be noted that the reliability of our study findings heavily depends on the cooperation and frankness of enrolled patients. Furthermore, concerns remain about the evaluation of stress reduction in patients submitted to CEA under general anesthesia. Both groups, cases and controls, received general anesthesia, and as a result, its effect on postoperative stress reduction could not be evaluated. This limitation may guide future research practice to explore the potential differences in stress reduction between CEA under general and locoregional anesthesia. Third, the study was open label, and this may have affected the validity of the reported findings. Finally, the used set of strict inclusion and exclusion criteria may undermine the generalizability of our observations. In conclusion, the results of this pilot, open-label, RCT provide first-ever evidence that relaxation techniques may be an effective method of preparing patients undergoing CEA in terms of stress and
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anxiety reduction. Our findings require independent confirmation in the setting of a larger, double-blind RCT. Relaxation techniques aim to reinforce skills and knowledge for managing stressful events after discharge from hospital. Considering also their low cost, they could be easily further supported in everyday clinical practice. Measurements of biological markers such as catecholamines, cortisol, or oxytocin might also be beneficial to assess the adequacy of relaxation techniques on stress and anxiety reduction in patients undergoing CEA. REFERENCES 1. Furie KL, Kasner SE, Adams RJ, et al. Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2011;42:227e76. 2. Chaturvedi S, Bruno A, Feasby T, et al. Carotid endarterectomyean evidence-based review: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2005;65:794e801. 3. Carr EC, Nicky Thomas V, Wilson-Barnet J. Patient experiences of anxiety, depression and acute pain after surgery: a longitudinal perspective. Int J Nurs Stud 2005;42:521e30. 4. Gallagher R, McKinley S. Anxiety, depression and perceived control in patients having coronary artery bypass grafts. J Adv Nurs 2009;65:2386e96. 5. Pearson S, Maddern GJ, Fitridge R. The role of pre-operative state-anxiety in the determination of intra-operative neuroendocrine responses and recovery. Br J Health Psychol 2005;10(Pt 2):299e310. 6. Schelling G, Richter M, Roozendaal B, et al. Exposure to high stress in the intensive care unit may have negative effects on health-related quality-of-life outcomes after cardiac surgery. Crit Care Med 2003;31:1971e80. 7. Manyande A, Berg S, Gettins D, et al. Preoperative rehearsal of active coping imagery influences subjective and hormonal responses to abdominal surgery. Psychosom Med 1995;57: 177e82. 8. Broadbent E, Kahokehr A, Booth RJ, et al. A brief relaxation intervention reduces stress and improves surgical wound healing response: a randomised trial. Brain Behav Immun 2012;26:212e7. 9. Kshettry VR, Carole LF, Henly SJ, et al. Complementary alternative medical therapies for heart surgery patients: feasibility, safety, and impact. Ann Thorac Surg 2006;81: 201e5. 10. Nilsson U. Soothing music can increase oxytocin levels during bed rest after open-heart surgery: a randomised control trial. J Clin Nurs 2009;18:2153e61. 11. Nilsson U. The effect of music intervention in stress response to cardiac surgery in a randomized clinical trial. Heart Lung 2009;38:201e7. 12. Grant EG, Benson CB, Moneta GL, et al. Carotid artery stenosis: gray-scale and Doppler US diagnosiseSociety of Radiologists in Ultrasound Consensus Conference. Radiology 2003;229:340e6. 13. Lazaris AM, Vasdekis SN, Gougoulakis AG, et al. Assessment of voice quality after carotid endarterectomy. Eur J Vasc Endovasc Surg 2002;24:344e8.
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14. Jerath R, Edry JW, Barnes VA, Jerath V. Physiology of long pranayamic breathing: neural respiratory elements may provide a mechanism that explains how slow deep breathing shifts the autonomic nervous system. Med Hypotheses 2006;67:566e71. 15. Cohen L, Parker PA, Vence L, et al. Presurgical stress management improves postoperative immune function in men with prostate cancer undergoing radical prostatectomy. Psychosom Med 2011;73:218e25. 16. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav 1983;24:385e96. 17. Andreou E, Alexopoulos EC, Lionis C, et al. Perceived Stress Scale: reliability and validity study in Greece. Int J Environ Res Public Health 2011;8:3287e98. 18. Pritchard MJ. Using the hospital anxiety and depression scale in surgical patients. Nurs Stand 2011;25:35e41. 19. Christodoulou C, Michopoulos J, Tournikioti K, et al. Hospital anxiety and depression scale. A quantitative analysis in medical outpatients, psychiatric outpatients and normal subjects. Psychiatriki 2010;21:279e86. 20. Wallston KA, Wallston BS, DeVellis R. Development of the Multidimensional Health Locus of Control (MHLC) Scales. Health Educ Monogr 1978;6:160e70.
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21. Karademas EC. Effects of exposure to the suffering of unknown persons on health-related cognitions, and the role of mood. Health 2009;13:491e504. 22. Orth-Gomer K, Schneiderman N, Wang HX, et al. Stress reduction prolongs life in women with coronary disease: the Stockholm Women’s Intervention Trial for Coronary Heart Disease (SWITCHD). Circ Cardiovasc Qual Outcomes 2009;2:25e32. 23. Bernatzky G, Presch M, Anderson M, Panksepp J. Emotional foundations of music as a non-pharmacological pain management tool in modern medicine. Neurosci Biobehav Rev 2011;35:1989e99. 24. Roffi M, Mukherjee D, Clair DG. Carotid artery stenting vs. endarterectomy. Eur Heart J 2009;30:2693e704. 25. Cohen DJ, Stolker JM, Wang K, et al. Health-related quality of life after carotid stenting versus carotid endarterectomy: results from CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial). J Am Coll Cardiol 2011;58:1557e65. 26. Stolker JM, Mahoney EM, Safley DM, et al. Health-related quality of life following carotid stenting versus endarterectomy: results from the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at HIgh Risk for Endarterectomy) trial. JACC Cardiovasc Interv 2010;3:515e23.
