Abstract / Summary
The prevalence of sleep disorders is high among patients undergoing hemodialysis. Hemodialysis patients, often constrained in using conventional sleep medications, face challenges in sleep quality. This study explores the potential impact of Passiflora oil on the sleep quality of patients undergoing hemodialysis. This study is a two-group, triple-blind clinical trial with the control group in the dialysis ward at Kashmar, Bardeskan, and Khalilabad dialysis centers in the Razavi Khorasan region, Iran between May and June 2023 in which a parallel pretest-posttest design was applied. A total of 65 participants were enrolled, with 32 in the control group and 33 in the intervention group. To gather comprehensive data, we utilized a demographic information questionnaire and the Pittsburgh Sleep Quality Index (PSQI), which was administered both before and after the intervention. Over six weeks, participants in the intervention group placed two cotton pieces infused with Passiflora oil (seven drops) on either side of their pillow, while the control group received a placebo (sweet almond oil substituted for Passiflora oil). Data analysis was conducted using SPSS software version 22 at a significance level of 0.05. The Chi-square test or Fisher’s exact test were employed to compare categorical baseline characteristics and the t-test or Mann-Whitney U test to compare continuous baseline characteristics between the two treatment groups. We also analyzed the difference in sleep quality between two groups using the t-test or Mann-Whitney U test and difference in sleep quality before and after intervention in the two groups by the paired t-test or Wilcoxon test. The effect of the intervention on sleep quality after the intervention was assessed using multivariable linear regression. Potential confounders were selected a priori based on clinical relevance. Missing values were handled via list wise deletion. Data analysis was conducted using SPSS software version 26 at a significance level of 0.05. The mean age of patients in the intervention group was 48.8 ± 14.4 years, while in the control group, it was 54.8 ± 11.6 years. The findings revealed a statistically significant difference between the intervention and control groups in the overall sleep quality score and its dimensions (including mental sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disturbances, and daytime dysfunction) after the intervention ( p < 0.05). Consistent with this between-group difference, the mean sleep quality score in the intervention group decreased from 12.2 before to 7.5 after the intervention. The results of this study showed that the application of Passiflora oil in aromatherapy significantly improves the sleep quality of patients undergoing hemodialysis. This implies that aromatherapy with this type of oil could be considered a practical and efficacious intervention for addressing sleep disorders in this population. Current Controlled Trials from Iranian Registry of Clinical Trials, protocol number IRCT20221212056801N1 registered on 2023-01-09.