Effect of Bitter Orange Blossom Distillate on Anxiety and Sleep Disorder in Mothers with Infants Admitted to Neonatal Intensive Care unit: A Randomized Controlled Clinical Trial

Abstract

Abstract Background: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.The aim of this study was to investigate the effect of bitter orange blossom distillate on anxiety and sleep disorder in mothers with infants admitted to neonatal intensive care unit. Methods:This randomized controlled clinical trial was conducted in 2021on 60 mothers with NICU-admitted infants in one of the medical teaching centers affiliated to 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. P value less than 0.05was considered significant. Reasults: 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 anxiety level of mothers(P> 0.05, Effect size < 0.06). Conclusions: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. Trial registration: IRCTID: IRCT20201209049666N1. Registered 15-04-2021. Retrospectively registered. https://www.cochranelibrary.com/es/central/doi/10.1002/central/CN-02280085/full https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20201209049666N1, 2021