This randomized clinical trial study was conducted on patients undergoing CABG surgery in open heart ICU of Busheher Bentolhoda Hospital, Iran in 2013. Inclusion criteria included having more than 25 years old, being Shia Muslim, being able to understand studies details, undergoing heart surgery for the first time, non-urgent heart surgery, as well as having stable hemodynamic conditions such as: systolic blood pressure more than 90 mmHg, absence of dangerous dysrhythmias and heart rate between 60 and 100 beats per minutes (
4). Exclusion criteria included connection to the ventilator at the time of intervention, history of chronic pains, lack of full consciousness, intubation more than 24 hours, bleeding more than 200 mL/hour from chest tube or anything that would affect patient cooperation. Moreover, patients were excluded if any complications during the operation and anesthesia occurred.
To estimate the sample size, a pilot study was conducted on 10 patients (included for the main sample). Based on the results and using the sample size formula with confidence level of 90%, the number of needed samples was calculated as 38.6 patients, but we considered 40 subjects in each group for more confident results.
Data was collected based on interview and patients’ records using a researcher-made questionnaire including three parts. The first part assessed demographic characteristics (age, gender, ethnicity, marital status, education and place of residence). The second part contained information related to the disease (history of hospitalization, history of previous surgery, duration of surgery, length of stay in the cardiac ICU, history of hypertension and duration of hypertension). The third part included details on vital signs (blood pressure, respiratory rate, pulse and temperature) as well as SpO2. To determine the scientific validity of this questionnaire, content validity was used. For this purpose, after studying books and other resources related to this subject, a checklist was prepared and then presented to 10 faculty members of nursing School of Ahvaz Jundishapur University of Medical Sciences and after collecting their suggestions, final checklist was prepared.
In this study, for measuring vital signs and SpO2 we used watches (Citizen Brand) and monitoring (Data Scope passport2) existed in open heart ICU of Busheher Bentolhoda Hospital. To assess the reliability of these instruments, we used equivalent form of reliability. At first, vital signs of 10 patients were assessed by researcher and his fellow who was in the same level of experience and qualifications, and then correlation was calculated which revealed no difference.
This study was approved by the ethics committee of Ahvaz University of Medical Sciences. After obtaining an introduction letter from this committee and representing it to Bushehr University of Medical Sciences and Hospital Managers, researcher in the night before the operation (at 7:30 PM) referred to the open heart ICU and selected patients who fulfilled the inclusion criteria. After obtaining an informed consent from all participants and providing verbal explanation about the research and assurance of confidentiality and anonymity, patients were randomly allocated to intervention (n: 40) and control (n: 40) groups using envelopes containing numbers from a table of random numbers. After surgery in the end of afternoon shift, at first we collected patients’ information and then vital signs and SpO2 rate of both groups were assessed in three times (24, 48 and 72 hours after surgery). Then, in the intervention group we asked patients to recite Hazrate Zahra’s praises (AS), in which the word “Allah” is repeated 100 times (34 times Allah Akbar, 33 times Alhamdulillah and 33 times Subhan Allah) for 10 to 15 minutes depending on the conditions alongside routine procedures of hospital. However, in the control group, patients just received routine procedures of hospital. Immediately after recitation, vital signs and SpO2 rate of both groups were assessed again in three mentioned times and results were compared.
Data was analyzed by SPSS 19 software using descriptive statistical tests (mean, standard deviation, numbers and percent) for demographic and clinical characteristics, Chi-square test for comparing qualitative data between the two groups and t-test for comparing quantitative data between two groups.
3.1. Ethical Considerations
This study was conducted after obtaining confirmation of Ahvaz Jundishapur Ethics Committee (ajums.res.13920253) and informed consent from all subjects participating in the study.