Cardiovascular disease is one of the most prevalent health problems and remains the leading cause of mortality and disability in many countries.1–3 In China, the estimated number of patients with cardiovascular diseases is 23 million, of whom more than 2 million have coronary heart disease (CHD).4 Clinically, although many techniques including exercise treadmill test, dynamic electrocardiogram, nuclide myocardial imaging, cardiac ultrasound, and coronary angiography have been applied to diagnose CHD, coronary angiography remains the criterion standard because of its superior spatial and temporal resolution. In China, approximately 1.3 million new CHD cases were confirmed by coronary angiography each year.5 However, because of hospitalization, treatment environment, unknown test results, and possible complications, patients who were hospitalized 2 to 3 days prior to coronary angiography for observation were especially prone to suffering from various negative mental disorders, such as anxiety, fear, and stress.6,7 Anxiety was the most common disorder.8,9 More than 82% of patients awaiting coronary artery angiography reported anxiety.10 The incidence rate was significantly higher than the general population or other patients.11
Anxiety is an unpleasant emotion that can increase patients’ psychological and physiological adverse effects including abnormal heartbeat, blood pressure (BP), heart output, and cardiac dysrhythmia that may cause severe procedural complications and exacerbate CHD symptoms.12,13 In order to reduce or prevent those adverse effects, it therefore is necessary to assess and treat anxiety in candidate CHD patients before coronary angiography.
Current medications, such as benzodiazepines, β-adrenergic receptor blockers, 5-HT, selective serotonin reuptake inhibitors, and tricyclic antidepressants, have been accepted to relieve anxiety, but they need to be used by caution for CHD patients because of the possible adverse effects or contraindications.14,15 Nonpharmaceutical interventions such as reflexology, massage, music, stress management, and social support have been gradually used to treat anxiety emotion in patients waiting for coronary angiography,16–24 among which music intervention was most common.16–21 However, although some studies have indicated that music intervention may be beneficial in reducing anxiety in patients undergoing coronary angiography,18,19 there remains uncertainty.20,21
On the other hand, Chinese hand massage care is a traditional Chinese medicine nursing technique derived from acupuncture. It is a manipulative method of massaging acupoints based on the meridian (jing-luo) theory of traditional Chinese medicine. In the traditional Chinese medicine, the mechanism underlying hand massage is thought to be related to regulate qi and blood, as well as yin and yang, rebalance the flow of vital energy through the meridians.22 The practitioners use their fingers’ physical pressure on the patients’ acupoints and attempt to open the body’s defensive chi to get the energy moving in the meridians.23 Chinese hand massage can relax tense muscles and relieve stress and pain by rubbing, kneading, and tapping the acupoints on the body with hands. It has widely been applied to clinical nursing in China such as recovering gastrointestinal function, relieving depression and pain, and improving sleep disorders.24–27 It is also a prevailing care approach for anxiety.28,29 Several studies have reported the effect of Chinese hand massage on alleviating anxiety among pregnant women or hypertension patients.30–33 However, the effect of Chinese hand massage care for the patients awaiting percutaneous coronary intervention (PCI) operation has not been tested. The purpose of this study was to evaluate the effectiveness and safety of Chinese hand massage care on anxiety among patients awaiting coronary angiography.
Study Design and Setting
A randomized, parallel controlled clinical trial was conducted during the period from May 2012 to September 2012 at the Department of Cardiology, Fujian Province Hospital, Fuzhou, China.
Study Population and Recruitment
Participants were recruited in a single hospital (Fujian Province Hospital) from April 10, 2012, to September 10, 2012, by advertising (posters, leaflets, and interviews). Potentially eligible participants were identified through screening patients’ medical records according to the following inclusion and exclusion criteria. The inclusion criteria included (1) patients with the typical CHD symptoms; (2) awaiting coronary angiography; (3) the scores of Hamilton Anxiety Scale greater than 13; (4) age from 40 to 79 years old without gender limitation; and (5) informed consent. The exclusion criteria were (1) patients with complications of severe liver, brain, kidney and digestive, and respiratory diseases and other severe somatic or mental comorbidities; and (2) patients receiving sedative drugs.
The eligible participants were asked to complete the demographic questionnaires and the baseline measurements including Hamilton Anxiety Rating Scale (HAMA), systolic BP, diastolic BP, heart rate, and contrast. They were randomly allocated to Chinese hand massage care group or control group according to the randomization schedule prepared by the Evidence-Based Medicine Center of Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine. The randomization sequence was generated by a statistician at the Evidence-Based Medicine Center who was not involved in the study using the PLAY PLAN program of SAS 8.12 software (SAS Institute, Inc, Cary, North Carolina). The allocation was kept in the sealed, opaque, consecutively numbered envelopes. When an eligible participant was enrolled and had completed the baseline measurement, the envelope was transmitted to the nurse practitioner who was not involved in the process of recruitment and outcome assessment.
Ethical approval was obtained from the Ethics Committee of Fujian Traditional Chinese Medicine University (no. 20120627). All participants were assured that they entirely voluntarily participated and could withdraw at any time. Their data were kept confidential. Informed written consent was obtained from all participants.
Participants in the control group received only conventional therapies and care, and those in the Chinese hand massage group received the same conventional therapies and care as the control group, with an additional 3-day Chinese hand massage intervention for 15 minutes a day.
Conventional Therapies and Cares
Conventional therapies and care for CHD were administered by the doctors or nurses on duty according to the guideline of PCI, which had been practiced for several years in the Fujian Provincial Hospital.34
Conventional therapies included antiplatelet and anticoagulation therapies at preoperation and postoperation: (1) antiplatelet therapy: aspirin 150 to 300 mg orally or 250 to 500 mg intravenously, followed by 75 to 100 mg daily, or clopidogrel 600 mg as loading dose and then 75 to 100 mg daily; and (2) anticoagulation therapy: low-molecular-weight heparin 60 IU/kg intravenous bolus with GPIIb-IIIa inhibitor or 100 IU/kg intravenous bolus without GPIIb-IIIa inhibitor daily; activated coagulation time was monitored until coronary angiography or PCI.
Conventional cares were as follows: (1) at preoperation: monitored the patients for chest pain, BP, and temperature; explained the cardiac catheterization to patients; explained the procedure and events of surgery if the patient was scheduled for it; stressed the need to follow the prescribed drug regimen; and encouraged the patients to maintain the prescribed diet; (2) during the procedure and post-procedure: monitored BP, heart rate, SPO2, and respiration every 0.5 to 1 hour daily; placed patients in a comfortable position; administered oxygen during operation and at post-procedure if prescribed; maintained continuous electrocardiogram with a 5-lead monitoring during operation and at 24 hours post-procedure; stressed the necessity to follow the prescribed drug regimen; carefully cared for the patients’ wounds post-procedure; noted the adverse effects post-procedure; reviewed specific factors that affected CHD development and progression; and highlighted and reduced those risk factors that could be modified and controlled.
Chinese Hand Massage
Chinese hand massage was modified and practiced on a few patients as a pilot test according to previous studies.35 It was administered only to the participants in the Chinese hand massage group by a designated expert nurse who was trained by professional and qualified massage personnel. The programs of Chinese hand massage care consisted of 3 sequent acupoints (Fengchi [EX-HN5], Shenmen [GB20], Taiyang [HT7]). The patients were massaged with a frequency of 15 minutes (5 minutes each acupoint) a day for 3 days before coronary angiography. The description of acupoints and manipulations were listed in Table 1 and Figure 1. Intensity of hand massage depended on the degree of patients’ tolerance, which was appropriate when DeQi sensation (slight soreness, distention, and numbness at the location of acupoint massaged) was experienced.
One researcher (X.M.) was in charge of the assessment of primary outcome at preintervention and postangiography and observed the participants to determine the answers. The baseline characteristics were obtained from the patients’ medical records. Secondary outcomes at postangiography were measured by another independent researcher (X.H.).
The primary outcome was the changes of the anxious degrees between groups measured by an outcome assessor (X.M.) using the HAMA.36 Hamilton Anxiety Rating Scale is a psychological questionnaire used to evaluate the severity of a patient’s anxiety. It contains 14 symptom-oriented questions, each given a severity rating from zero (scored as 0) to very severe (scored as 4). Outcome assessor judged the possible score for each symptom-oriented question by interviewing the patient or observing the patient’s symptoms.37 Cronbach’s α of reliability and validity coefficient for the HAMA were .93 and .36, respectively.37 The coefficient for each item and its related domains was obtained by the correlation coefficient model.
Secondary outcomes included BP, heart rate, and quality of life (assessed using the Short-Form Health Survey [SF-36]). The SF-36 is a multipurpose, short-form health survey with 36 questions.38 It consists of 8 dimensions, which are vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each dimension is directly transformed into a 0- to 100-point scale on the assumption that each question carries equal weight. The Chinese version of the SF-36 has been confirmed for excellent reliability and validity.39,40
The Adverse Events
The adverse events were defined as functional lesions caused by the hand massage care manipulations, such as local swelling, numbness, pain at the massaged region, and dizziness. They were recorded during the intervention period.
Sample Size and Data Analysis
The calculation of sample size was based on the previous studies with a mean of the anxiety scores being 35.69 (SD, 17.09) in the intervention group and 26.14 (SD, 19.04) in the control group.41 According to the formula,
, with type I error of 5% (α = .05) and 90% power (β = .1), 50 patients were required in each group to show the statistical difference between groups with a 5% dropout rate.
Statistical analyses were performed using Statistical Package for the Social Sciences program 21.0 (Chicago, Illinois). Data were described as frequencies, percentages (%), means and SDs, or median and ranges. For the variables with a normal distribution, statistical comparisons between the groups were determined by t test. If the variables had a nonnormal distribution or ordinal level, statistical comparisons between groups were determined by nonparametric Mann-Whitney U test. Comparison of pre- and post-HAMA scores whether in Chinese hand massage group or control group was analyzed by the paired-sample t tests if the normality was met, or else 2-related-samples Wilcoxon test was used. Measures with a discrete distribution were analyzed by χ2 or Fisher exact test if appropriate. All tests were 2-tailed, and significance was set at .05.
A total of 185 potential participants were identified from the Department of Cardiology, Fujian Province Hospital. As shown in Figure 2, 55 individuals did not meet eligible criteria, 23 were excluded because of exclusion criteria, and 7 refused to participate. As a result, 100 eligible patients were recruited.
Tables 2 and 3 summarized participants’ demographic characteristics, baseline data, angiography, and stent characteristics. There were no statistically significant differences between the Chinese hand massage and control groups in terms of participants’ demographic characteristics and baseline outcome variables (all P > .05; Table 2). No significant difference was indicated between the 2 groups in their angiography and stent characteristics (all P > .05; Table 3).
As shown in Table 4, in both groups, the HAMA scores of postangiography were significantly lower compared to preangiography scores (both P < .01). The HAMA scores in the Chinese hand massage group (11.78 [SD, 2.9]) had a statistically significant decrease at postangiography compared with those in the control group (15.96 [SD, 3.4]; P < .01). Furthermore, there was also statistically significant difference in the changes of HAMA scores from preangiography to postangiography between the 2 groups (P < .01).
There was no statistically significant difference in BP (including systolic BP and diastolic BP), heart rate, and SF-36 at postangiography between the Chinese hand massage group and the control group (Table 5).
No adverse event was reported during the intervention period.
This study was a randomized, single-blind, parallel controlled trial testing the effectiveness and safety of Chinese hand massage on anxiety among the patients awaiting coronary angiography.
Our results showed that the Chinese hand massage care significantly reduced anxiety symptoms in these patients, consistent with previous studies among other patients.42,43 The possible mechanism might be that Chinese hand massage improves the parasympathetic nerve activity and reduces the sympathetic nervous activity and decreases the secretion of epinephrine and norepinephrine.44,45 The results of this trial also showed the anxiety symptoms at post-angiography were significantly lower than pre-angiography regardless of the Chinese hand massage group or control group, probably reason related to spontaneous decrease of anxiety with completing of angiography. For the secondary outcomes, no significant changes were observed on BP, heart rate, and SF-36 after Chinese hand massage, probably due to the short intervention duration (only 3 days) in this study.
There were some obvious limitations in the current study. First, the waiting period from admission to coronary angiography was usually 2 to 3 days in the hospital. Thus, the patients received only hand massage intervention for a total of 3 days, which might be too short. Second, because the follow-up after intervention was not designed because of self-funding, the intermediate- and long-term effectiveness of Chinese hand massage care for anxiety cannot be observed. Third, it was impossible to blind the participants because of the visible intervention administered; therefore, the performance bias may be inevitable.
In summary, the current findings indicate that the Chinese hand massage was effective in alleviating anxiety among patients awaiting coronary angiography. Therefore, Chinese hand massage may be recommended as an effective nursing intervention because it is a nonpharmacological management without any adverse effects. However, future study with a larger sample is needed to confirm its efficacy.
What’s New and Important
- The prevalence of anxiety is high in patients awaiting coronary angiography operation, which may cause high operative complications, even exacerbate CHD symptoms. Therefore, it is necessary to treat anxiety before coronary angiography operations.
- Administering current accepted medications for anxiety needs to be done with caution in CHD patients because of the possible adverse effects such as prodysrhythmic and cardiotoxic effects.
- As an alternative and complementary treatment, Chinese hand massage, a manipulative method of hands-on acupoints, is a common approach used for anxiety in China. It may be effective and safe to alleviate anxiety in patients awaiting coronary angiography operation, but the evidence is limited. This randomized controlled trial with rigorous design demonstrates that Chinese hand massage is effective to alleviate anxiety among patients awaiting coronary angiography.
The authors like to acknowledge all nursing staff in the Department of Cardiology, Fujian Province Hospital, for their assistance with this project.
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Keywords:Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved
anxiety; Chinese hand massage; complimentary/ alternative therapy; coronary angiography; effectiveness and safety; randomized controlled trial