3.1. Type of Study and Sampling Method
This randomized controlled trial (ethics code:
IR.MAZUMS.REC.1398.1394) was conducted in the Intensive Care Unit of Fatemeh Zahra Hospital in Sari, Iran, where patients were subject to CABG in 2021. The sample size of this sample was determined based on a previous study (
18). The mean values of anxiety changes after the intervention were 6.2 ± 6 and 0.6 ± 8.7 in the intervention and control groups, respectively, which were included in the sample size formula. In addition, α = 0.05, β = 0.2, and m (i.e., number of repetitions before and after), P = 0.2 (i.e., the correlation coefficient of scores before and after), and ef = 0.6 (i.e., effect size) were taken into consideration in the formula for the sample size. The minimum sample size in each group was 28. This is the minimum sample size, and with a sample drop of 20%, 33 subjects were included in each group.
The inclusion criteria were a minimum age of 18 years for candidates of CABG, no pulmonary drain or discharge exceeding 200 cc/hour, no left ventricle ejection fraction below 35%, no medication use within the past 4 hours, and no prior experience with acupuncture or massage. There were no communication difficulties (i.e., hearing or visual impairments, speech impairment, drug use, mental illness under treatment, and use of anti-anxiety medications, depression medications, or antihistamines within 4 hours of the intervention). Moreover, there was no evidence of severe neuropathy, sores, or infection on the soles and the bottom of the feet, no limb amputation, no history of osteoarthritis and rheumatoid arthritis, valve replacement, or treatment, no need for intra-aortic pumps balloon, and no more than 24 hours of intubation (
19,
20). In this study, there was no previous experience with massage, acupressure, or acupuncture during the last 3 weeks. Scores of 45 and higher on the Templer Death Anxiety Questionnaire are considered to be a sign of death anxiety (
21), and vital signs were stable (blood pressure, body temperature, pulse, respiration rate). The exclusion criteria included patient refusal to participate, critical patient conditions, return to the operating table, need to take antidepressant or anxiety medication, and the need to use antihistamines.
After the surgery, the eligible patients were assigned into two 33-member groups on the second day (i.e., intervention and control groups using random numbers through computer software and permuted-block randomization). There were 66 envelopes made. The computer software embedded letters A (reflexology) and B (control) in each envelope. The envelopes were numbered from 1 to 66.
3.2. Study Tools
In this study, three questionnaires were completed the day before the surgery. A checklist was used to gather the sociodemographic data (e.g., age, height, weight, body mass index, gender, marital status, occupation, and educational level) and medical data extracted from patients’ records, including a history of underlying diseases, history of myocardial infarction, number of heart grafts, location of grafts, and graft incision length.
The Templer DAS was developed by Donald I. The Templer scale measures the extent of death anxiety a person experiences. The Templer DAS consisted of 15 items intended to be rated on a dichotomous scale of true or false by the respondents. The test-retest of DAS with an interval of 3 weeks demonstrated a 0.83 correlation coefficient. A good internal consistency (0.76) was obtained with 31 participants through the Kuder-Richardson Formula (
20). The DAS response category was revised by Templer and McMordie, introducing a Likert format for the scale. Therefore, it can be used in both true-false and Likert formats (
22). The Likert-type format provides a rating on a continuum of 1 = strongly disagree, 3 = neutral, and 5 = strongly agree. The scores range from 15 to 75, with low (15 - 35), moderate (36 - 55), and high (56 - 75) death anxiety. Consequently, a high score reveals high death anxiety. For the Likert-type format, the test-retest reliability was 0.83; nevertheless, internal consistency was 0.84. McMordie stated that the Likert-scale format amplifies the capacity to differentiate between high and low scores (
23). Furthermore, Saleem et al. stated that using a 5-point Likert scale enhances the scale’s sensitivity to differences among participants (
21).
In the present study, the respondents could rate themselves based on a 5-point Likert scale (strongly agree, somewhat agree, no opinion, somewhat disagree, and strongly disagree). In a study by Tavakoli and Ahmadzadeh, the scale’s validity was obtained using factor analysis that showed five factors with eigenvalues higher than 1. In addition, item-total correlations were evaluated. The reliability coefficients of the scale using test-retest, split-half, and Cronbach’s alpha were 0.87, 0.59, and 0.75, respectively. Overall, the DAS had appropriate validity and reliability (
24). The scale’s internal consistency in the present study was estimated at 0.87 by Cronbach’s alpha.
The Subjective Well-being Scale (SWB) approved by the World Health Organization contains five items (i.e., I am happy and cheerful, I feel calm, I feel active and energetic, I wake up refreshed and relaxed, and my daily life is full of my favorite things). Moreover, the SWB’s response options in the Likert scale were always, most of the time, little more than half of the time, little less than half of the time, sometimes, and never, which were scored from 5 to 0, respectively. The total score of this questionnaire is calculated out of 100, and to achieve this, the scores of each person are multiplied by 4. Therefore, the score range of this questionnaire is from 0 to 100, and a score higher than 50 indicates higher well-being (
25). The reliability was evaluated in a pilot study on 2317 patients with hypertension and coronary artery disease, and Cronbach’s alpha for this questionnaire was 0.95 (
25). The internal consistency of the scale in Rafie et al.’s study (2020) was estimated at 0.76 by Cronbach’s alpha (
23). The present study was performed on 15 patients, and Cronbach’s alpha coefficient for the well-being scale was 0.74.
The Hospital Anxiety and Depression Scale (HADS) consists of 14 items and two subscales, anxiety and depression. Each item is rated on a 4-point scale, with a maximum score of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity; however, scores of 8 - 10 and 0 - 7 represent borderline and normal, respectively (
22).
The Templer DAS and SWB questionnaires were completed by the intervention and control groups on the day before the surgery, the second day after the surgery, before the start of the study, and the fourth day after the surgery after the massage.
3.3. Intervention Methodology
The research was started the day before the operation after providing the necessary explanations on how the study will be performed, its duration, and the principles of confidentiality of personal information to the patient and a companion and obtaining written and informed consent from them.
Massage course sessions were run by the researcher team under the supervision of an acupuncturist. Massage therapy nurses received training in the massage protocol and practiced the sequence until their performance reached the criteria for standardization and got a certificate. The nurse of the same gender, who was trained by the acupuncturist, provided massage therapy. Reflexology massage of the foot sole was performed in the evening (between 16:00 and 18:00) on the second day after the surgery for 3 consecutive days (i.e., the second to fourth day after the surgery).
At first, using 5 drops of baby oil, the feet were gently massaged with the palms of the hands until they were completely oily, and all parts of the feet were lubricated with oil. Two techniques were used to perform reflexology massage, including general foot massage and specialized massage, which included massaging the toes. The general and specialized massage lasted about 5 and 10 minutes, respectively. For this purpose, the patient laid on his/her back on the bed, and two pillows were placed under his/her feet; accordingly, the heel area and the Achilles tendon were not in contact with the pillow, and the feet were free in the air. Then, using 5 drops of baby oil, the feet were gently massaged with the palms of the hands until all parts of the feet were completely oily. For general massage, the hands were placed such that the fingers covered the top of the feet and the thumbs covered the soles of the feet. Then, the pressure was gently applied to the feet to relieve the cold feeling of the feet and warm them in unison using the hands and performed on different parts of the feet. For specialized massage, the thumb was put on the big toe, and the hand was moved toward the second phalange, and then we moved in a circular motion with the thumb of the right hand on the thumb of the left foot. This was also repeated for the other toes (
26). No massage was given for the control group, and postoperative care training was performed based on the ward’s routine principles.
3.4. Data Analysis
Descriptive statistics (i.e., frequency and percentage for qualitative variables and mean and standard deviation for quantitative variables) were used to describe the variables. This study considered death anxiety and well-being as the primary and secondary outcomes, respectively. The Mann-Whitney U test compared death anxiety and well-being in the intervention and control groups. The generalized estimating equations (GEE) test was used to compare the changes the day before the surgery and the second and fourth days after the surgery. Friedman’s test was used to find differences in the treatment across multiple attempts within each group. In addition, ANOVA, independent t-test, and chi-square test were used for the statistical analysis of sociodemographic and medical data. In this study, data analysis was performed according to per-protocol. The Shapiro-Wilk test was used to evaluate the normality of the distribution of variables. SPSS software (version 20) was employed to analyze the collected data. A P-value of less than 0.05 was considered the level of significance.