This prospective, single-blind, randomized clinical trial with pre-test-post-test design and parallel groups was performed on 90 patients undergoing open-heart surgery from 2020 to 2021. The study population included all patients undergoing open heart surgery referred to Kowsar Shiraz Hospital. The report of this study is based on the CONSORT checklist (
Figure 1).
CONSORT 2010 flow diagram
Based on previous studies (
18) and by using the mean comparison formula, α = 0.05, β = 0.2, power = 0.8, S1 = 2.45, S2 = 1.61, d = 1.3 and attrition rate = 10%, the sample size was calculated 45 people in each group.
The inclusion criteria included willingness to participate in the study, ability to participate in therapeutic sessions, reading and writing literacy, age between 20 to 65 years, residence at the study setting, full consciousness and ability to speak Persian, physical and mental readiness to answer questions, and gaining Pittsburgh Sleep Quality Index (PSQI) score > 5. Participating in other educational and treatment classes simultaneously, having a specific mental illness before surgery (according to the patient's report), and having other illnesses such as malignancies or autoimmune disorders (according to the patient's report) were considered the main conditions for not including the study.
The exclusion criteria also included exposure to specific psychological crises during the work process, initiation of other psychiatric treatments (according to the patient's report or doctor's order), the need for readmission to the hospital, and missing more than 3 sessions to perform the intervention.
Each of the final samples was given a code from one to 90 (sample volume number). Then, using R software and sample command, 45 codes out of 90 codes were randomly allocated to the intervention group, and the rest of the codes represented the codes of the samples in the control group.
For blinding in the present study, the referral days of patients in the intervention group to receive counseling were considered different from the referral days of patients in the control group.
After obtaining permission, the researcher visited the study setting. She introduced herself, explained the objectives of the study, and obtained the consent of the relevant authorities.
Patients were admitted to the intensive care unit 1 to 2 days before heart surgery for necessary measures. During the preoperative period, patients who met the inclusion criteria were interviewed, and their oral and written consent to be included in the study was obtained. The PSQI tool was used for measuring sleep quality among patients. If a patient did not have a sleep disorder in the initial interview based on this instrument, a second interview would be performed 4 to 5 weeks after discharge. If the patient had sleep disorders in the second interview, he or she would be randomly assigned to one of the 2 intervention or control groups. The intervention group includes people who have developed sleep disorders after surgery, for whom, in addition to the usual care of the treatment center, the CBT-I protocol was also considered (
19,
20). The control group included people who developed sleep disorders after surgery but only received the usual post-operative cardiac care at the hospital. Usual care included routine medical and nursing follow-up after heart surgery, which was mostly done to resolve patients' physical problems. The patient's mental status was not usually evaluated by a psychiatrist unless advised by a heart surgeon.
The CBT-I protocol was administered at a time and place previously coordinated with the patient by a trained and certified critical care nurse (researcher 2). Weekly sessions followed a standard format, including mood review, cross-programming, discussion, assignments, and feedback.
Table 1 presents the weekly schedule:
| Content | Education Method | Duration of Sessions (h) | Place of Sessions | Instructor | Number of Sessions (Week) |
|---|
| Applying therapeutic communication, setting the agenda, identifying problems objectively, and setting intervention goals | Individually and face-to-face | 1 | Counseling room of Cardiac Surgery Department of Kowsar Kowsar Hospital, Shiraz | Master of Critical Care Nursing with a CBT degree | 1th |
| Increasing patients' knowledge, activating behavioral functions and problem-solving methods | 2th |
| Identifying automatic thoughts, improving problem-solving skills, reducing dysfunctional cognitive processes on behavior | 3 - 4th |
| Reconstructing automatic thoughts, identifying abilities, and learning self-healing techniques | 5 - 6th |
| Continuing self-medication and preventing a recurrence | 7 - 8th |
| Training to improve skills related to self-care in the field of the disease and increasing acceptable, enjoyable activities according to the condition of the disease, ending the intervention, terminating the therapeutic relationship | 9 - 10th |
In this intervention, 2 extra sessions were considered for completing the questionnaire or if some sessions needed to be longer and required to continue the intervention. After 10 - 12 sessions of CBT-I treatment in the intervention group, both intervention and control groups were reevaluated with the instrument. To consider the ethical principles, we administered a complete course of nurse-led CBT-I for the control group after the end of the study. To prevent the exchange of information between the intervention group and the control group and to prevent data contamination, we invited the patients in the control group on the first three days of the week and the patients in the intervention group on the second three days of the week.
Demographic data and PSQI were used to collect data. The demographic information questionnaire includes information about age, sex, duration of cardiopulmonary bypass, type of surgery, length of hospital stays, history of diabetes and hypertension, BMI, use of diuretics, smoking, and participation in sports programs, and ejection fraction (EF) of patients.
The PSQI, which is one of the best tools designed to measure sleep quality, was used to measure sleep quality. This questionnaire was developed in 1988 by Dr. Buysse et al. at the Pittsburgh Institute of Psychiatry. This questionnaire includes 19 self-rated items and 7 components: Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is scored on a 0-3 Likert scale. In all items, a score of "0" indicates no difficulty, and a score of "3" indicates severe difficulty. The total sleep quality score is calculated from the sum of the scores of 7 components (0 to 21). A PSQI score higher than 5 indicated poor sleep quality, whereas a PSQI score equal to or lower than 5 indicated good sleep quality (
21-
23). Buysse et al., who designed this questionnaire, obtained the internal consistency of the questionnaire using Cronbach's alpha of 0.83 (
23). In Farrahi Moghaddam et al.'s study, the validity and reliability of the Iranian version of this questionnaire were confirmed (a = 0.77) (
24). In the present study, the internal consistency method was used to evaluate the reliability of the questionnaire. Cronbach's alpha coefficient of PSQI was 0.716 and had appropriate reliability.
In the present study, the nurse-led CBT-I and sleep quality were independent and dependent variables, respectively. SPSS v. 22 (IBM Corp., Armonk, NY, USA) was used to analyze collected data, and descriptive statistics such as frequency, percentage, mean, and standard deviation were utilized to describe the characteristics of the data. Kolmogorov-Smirnov and chi-square (X2) tests were used to investigate normal distribution in quantitative variables and analyze demographic information, respectively. Independent sample t-test was used to compare the mean sleep quality score between the 2 groups before the intervention, and the paired t-test was applied to compare the mean sleep quality before and after the intervention in each group. Analysis of covariance (ANCOVA) was used to compare the mean score of sleep quality after the intervention in the 2 groups under study. The significance level was considered less than 0.05 (P < 0.05).