Abstract
Sleep disorder is very common during pregnancy. Non-pharmacological treatments are a priority to improve the sleep pattern. This study aimed to determine the effect of cognitive-behavioral counseling with or without Citrus aurantium essential oil on sleep quality (primary outcome) and anxiety and quality of life (secondary outcomes). This randomized controlled trial was performed on 75 pregnant women in Tabriz, Iran. Participants were randomly assigned to the intervention and control groups. The first intervention group received 8 sessions of cognitive-behavioral counseling and aromatherapy with Citrus aurantium essential oil 15-20 min before bedtime. The second intervention group received cognitive-behavioral counseling and aromatherapy with placebo and the control group received only routine prenatal care. Pittsburgh Sleep Quality Index, Pregnancy-Specific Quality of life Questionnaire, and Pregnancy-Specific Anxiety Scale were completed before and after intervention. After the intervention based on ANCOVA test and by adjusting the baseline score, the mean score of anxiety in the intervention group 1 (AMD: - 4.54; 95% CI - 6.79 to - 2.28) and intervention group 2 (AMD: - 3.30; 95% CI - 5.60 to - 0.97) was significantly lower than the control group. Also, the mean score of quality of life in intervention group 1 (AMD: 2.55; 95% CI 0.45-4.65) and intervention group 2 (AMD: 2.72; 95% CI 0.60-4.83) was significantly higher than the control group, but there was no statistically significant difference between the study groups in terms of sleep quality (P > 0.05). Also, there was no statistically significant difference between the two intervention groups after the intervention in terms of anxiety (P = 0.379) and quality of life (P = 0.996). Cognitive-behavioral counseling reduced anxiety and improved quality of life. However, further trials are required to reach a definitive conclusion. Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N63. Date of registration: 4/10/2020. URL: https://en.irct.ir/user/trial/54986/view; Date of first registration: 18/10/2020.