Student Research Committee, Babol University of Medical Sciences, Babol, Iran.
Nursing Care Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.
PLoS One. 2024 Aug 12;19(8):e0306887. doi: 10.1371/journal.pone.0306887. eCollection 2024.
Mothers of neonates admitted to the intensive care unit are prone to sleep disorders due to stress and anxiety. Some herbs have anti-anxiety and sedative properties. This study aimed to investigate the effect of bitter orange blossom distillate on anxiety and sleep disorders in mothers with infants admitted to the neonatal intensive care unit.
This randomized controlled clinical trial was conducted from 2021 May 15 to 2022 February 2, on 60 mothers with NICU-admitted infants in one of the medical teaching centers affiliated with Babol University of Medical Sciences, Iran. Permuted block randomization was used to assign the mothers to the experimental (bitter orange blossom distillate syrup) and control groups (syrup prepared from water and sugar). Given the impossibility of blinding the participants, allocation concealment was used to prevent the researcher from predicting the future allocation of the samples to the groups. In addition, the statistical consultant received coded data pertaining to the type of intervention in each group. A demographic questionnaire, the Spielberger State and Trait Anxiety Inventory (STAI), and the General Sleep Disorder Scale were employed to collect data. We assessed the level of anxiety and sleep disorder (in both groups before the intervention and again after the last day of the intervention). Data were analyzed using SPSS V22 software. A P-value less than 0.05 were considered significant.
The mean and standard deviation of the sleep disorder score in the intervention group from (50.26±5.81) to (44.70±6.94) and in the control group from (50.46±6.95) to (48.53±8.62) changed. The covariance test showed that bitter orange blossom distillate syrup has a significant effect on the improvement of sleep disorders (P = 0.01, Effect size = 0.09), but there was no significant difference in the State and Trait anxiety level of mothers (P = 0.122, 0.144 and Effect size = 0.04, 0.03) respectively.
Due to the positive effect of bitter orange blossom distillate syrup on sleep disorders of mothers with hospitalized babies, this low-cost and low-risk intervention is recommended.
This study is registered at clinicaltrials.gov as Trial ID = IRCT20201209049666N1.
由于压力和焦虑，新生儿重症监护病房（NICU）患儿的母亲容易出现睡眠障碍。一些草药具有抗焦虑和镇静作用。本研究旨在探讨苦橙花蒸馏液对 NICU 患儿母亲焦虑和睡眠障碍的影响。
这是一项于 2021 年 5 月 15 日至 2022 年 2 月 2 日在伊朗巴博勒医科大学附属医院进行的随机对照临床试验，纳入了 60 名 NICU 患儿的母亲。采用区组随机化方法将母亲分配至实验组（苦橙花蒸馏液糖浆）和对照组（水和糖制成的糖浆）。由于无法对参与者进行盲法，因此采用分配隐藏来防止研究人员预测未来样本对组的分配。此外，统计顾问收到了关于每组干预类型的编码数据。采用一般人口统计学问卷、斯皮尔伯格状态和特质焦虑量表（STAI）和一般睡眠障碍量表来收集数据。我们评估了焦虑水平和睡眠障碍（两组在干预前和干预最后一天后）。使用 SPSS V22 软件分析数据。P 值小于 0.05 被认为具有统计学意义。
干预组的睡眠障碍评分从（50.26±5.81）降至（44.70±6.94），对照组从（50.46±6.95）降至（48.53±8.62）。协方差检验表明，苦橙花蒸馏液糖浆对改善睡眠障碍有显著效果（P = 0.01，效应量=0.09），但对母亲的状态和特质焦虑水平无显著差异（P = 0.122，0.144 和效应量=0.04，0.03）。
由于苦橙花蒸馏液糖浆对住院婴儿母亲睡眠障碍有积极影响，因此推荐这种低成本、低风险的干预措施。
本研究在 clinicaltrials.gov 注册，注册号为 IRCT20201209049666N1。
