This randomized clinical trial was conducted in 2017 in a ward of Nekouei-Hedayati Hospital, Qom University of Medical Sciences. The sample size included 80 eligible patients admitted to the burn ward who entered the study by simple random allocation. According to the mean and standard deviation of pain severity due to dressing change in patients with burns in Avazeh et al.’s study (
15) (7.85 ± 4.1 in the control group and 5.21 ± 3.2 in the experimental group) and considering the formula for comparing the means, α = 0.05, and β = 0.1, the sample size was calculated as 40 individuals in each group.
Inclusion criteria were willingness to participate in the study, having Islam religion (Shia), believing in Islamic dhikr, having a minimum level of literacy and the ability to speak and communicate, having passed the emergency stage, entering the acute stage of burn (that starts from 48 - 72 hours after the burn onset), having a second or third-degree burn, having a burn rate of 20 - 50%, the patient’s wound freshness, and the patient’s alertness and his need for povidone-iodine bandages. Exclusion criteria included the patient’s unwillingness to continue the study.
After obtaining the approval of the Ethics Committee of Qom University of Medical Sciences and the code of the Iranian Registry of Clinical Trials (IRCT20140428017468N5), sampling was done under the ethical considerations of the Helsinki Declaration (
19). First, the questionnaire of demographic and clinical characteristics (age, sex, place of residence, marital status, body mass index, belief in Islamic dhikr, ethnicity, length of stay, cause, and agent of burns, burn site, burn percentage, and substance-related disorders) was completed for each patient by a research colleague. Then, participants were selected by convenience sampling and assigned to experimental and control groups using stratified random sampling. First, classes were created for each combination of burn degree (including two classes: First-degree burn and second-degree burn), percentage (including two classes: Two numerical intervals), and agent (including three classes: Thermal, electrical, and chemical). Then, the patients were assigned to the appropriate class of the variables, and a simple random method (lottery) was performed in each category to assign patients to one of the groups.
Patients in both groups received analgesics and sedatives on demand, and their type, dosage, time, and frequency were recorded. Then, 10 minutes before the dressing change in the dressing room, patients were asked to recite the praises of Hazrat Fatima (PBUH), which included repeating God’s name 100 times (34 times “Allah Akbar,” 33 times “Alhamdulillah,” and 33 times “Sobhan Allah”). The control group received only routine care. Patients’ pain severity was measured before and 15, 30, 45, and 60 minutes after the dressing change in both groups. A research colleague administered the modified McGill Pain Questionnaire (MPQ) 15 minutes after starting the dressing change to assess pain quality during the dressing change. In the present study, research unit randomization, data entry, and data analysis were performed by research colleagues.
The Visual Analog Scale for pain consists of a 10-cm-long vertical or horizontal line numbered from zero to 10 (a score of zero indicates a lack of pain, and a score of 10 shows the maximum pain the patient could imagine). The validity of the Visual Analog Scale for pain has been confirmed in several studies (
20,
21). The reliability of this scale has also been confirmed using the retest method in Gallagher et al.’s study, with r = 0.99 (
20).
The modified MPQ consists of 12 words to assess pain quality in sensory (nine words) and emotional (three words) dimensions of pain. The response to each word is classified as “at all,” “mild,” “moderate,” and “severe,” and the scores assigned to these answers are “0”, “1”, “2”, and “3”, respectively. A total score of “0” indicates the minimum total score, and a score of “36” indicates the maximum total score. This questionnaire was completed after the dressing change by asking the patient by a research colleague. The patient was asked to report pain quality during the burn dressing change by choosing the appropriate words after the dressing change. For content validity, this questionnaire was first translated and edited by a linguist and then reviewed and approved by Mazlom et al. by five faculty members of Mashhad University of Medical Sciences (
22). After collecting and coding, the data were entered into the computer. After ensuring the accuracy of data entry, the normal distribution of quantitative data was assessed by the Shapiro test. Descriptive statistics and statistical tests (such as independent
t-test, analysis of variance (ANOVA), repeated-measures analysis, chi-square, and Fisher exact test) were used to analyze the data using SPSS software version 22. A 95% confidence interval (α = 5%) was considered for the performed tests. The collected data from nine patients in the study were incomplete. Therefore, statistical analysis was done on the remaining 71 patients (
Figure 1).