Rahmani Narges, Araj-Khodaei Mostafa, Mohammad-Alizadeh-Charandabi Sakineh, Esmaeilpour Khalil, Montazeri Maryam, Mirghafourvand Mojgan
Nursing and Midwifery Faculty, Tabriz University of Medical Sciences, Tabriz, Iran.
Department of Persian Medicine, Faculty of Traditional Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
Sleep Biol Rhythms. 2023 Feb 5;21(3):337–346. doi: 10.1007/s41105-023-00451-7. eCollection 2023 Jul.
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 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 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 ( > 0.05). Also, there was no statistically significant difference between the two intervention groups after the intervention in terms of anxiety ( = 0.379) and quality of life ( = 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.
睡眠障碍在孕期非常常见。非药物治疗是改善睡眠模式的首要选择。本研究旨在确定有无精油辅助的认知行为咨询对睡眠质量（主要结局）、焦虑及生活质量（次要结局）的影响。这项随机对照试验在伊朗大不里士的75名孕妇中进行。参与者被随机分配到干预组和对照组。第一个干预组在睡前15 - 20分钟接受8次认知行为咨询和精油芳香疗法。第二个干预组接受认知行为咨询和安慰剂芳香疗法，而对照组仅接受常规产前护理。在干预前后分别完成匹兹堡睡眠质量指数、特定孕期生活质量问卷和特定孕期焦虑量表。干预后，基于协方差分析并调整基线评分，干预组1（平均差值：- 4.54；95%置信区间- 6.79至- 2.28）和干预组2（平均差值：- 3.30；95%置信区间- 5.60至- 0.97）的焦虑平均得分显著低于对照组。此外，干预组1（平均差值：2.55；95%置信区间0.45 - 4.65）和干预组2（平均差值：2.72；95%置信区间0.60 - 4.83）的生活质量平均得分显著高于对照组，但在睡眠质量方面研究组之间无统计学显著差异（> 0.05）。而且，干预后两个干预组在焦虑（= 0.379）和生活质量（= 0.996）方面也无统计学显著差异。认知行为咨询可减轻焦虑并改善生活质量。然而，需要进一步试验才能得出明确结论。伊朗临床试验注册中心（IRCT）：IRCT20120718010324N63。注册日期：2020年10月4日。网址：https://en.irct.ir/user/trial/54986/view；首次注册日期：2020年10月18日。
