]>
IRCT20201209049666N1 IRCT 2021-04-15 Babol University of Medical Sciences The Effect of Citrus Aurantium distillate on Anxiety and Sleep Disorder in mothers with neonate admitted to neonatal intensive care unit Comparison of the effectiveness of Citrus Aurantium distillate on anxiety and sleep disorders in mothers with infants 2021-05-03 anticipated 60 Complete https://irct.ir/trial/54972 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Mothers were divided into two equal and identical groups using the method of randomization of permutation blocks.First, blocks of size 4 consisting of two A and two B are created. In each block, the order of receiving A and B will be random. In a table of 60 cells, all four permutations of the two interventions will be randomized. A three-digit code is assigned to each house to hide the allocation process using a random number table. 2-3 Condition 1: Sleep Disorders. Condition 2: Anxiety. Intervention 1: Intervention group: Citrus Aurantium distillate 500 mg, twice daily + Fluoxetine 20 mg daily for 7 days. Intervention 2: Control group: Fluoxetine 20 mg daily plus placebo (Water + sugar)for 7 days. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main outcome or the like, can be shared. When: One year after printing To whom: All researchers Conditions: Students only to advance their dissertation work Where to obtain: zahra dehghan shdehghan29@gmail.com How to obtain: Have a valid scientific degree Comments:
public zahra Dehgan
Babol University of Medical Sciences, Ganj Afrooz St.
babol Iran (Islamic Republic of) 9491863689 +98 51 4622 5472 info@mubabol.ac.ir Babol University of Medical Sciences scientific zahra dehghan
Babol University of Medical Sciences, Ganj Afrooz St.
Babol Iran (Islamic Republic of) 9491863689 +98 51 4622 5472 shdehghan29@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having literacy No history of disease 7 days have passed since the baby was admitted Score 43 or higher General Sleep Disorder Lack of sensitivity to plants No history of premature infants Not having various problems in pregnancy such as heart disease and ... 18 years no limit Female Infant hospitalization less than 14 days in the neonatal intensive care unit The mother's unwillingness to continue participating in the study Occurrence of unpleasant events for the mother Maternal sensitivity to orange spring sweat G47.8 F06.4 Other sleep disorders Anxiety disorder due to known physiological condition Treatment - Other Treatment - Other Intervention group: Citrus Aurantium distillate 500 mg, twice daily + Fluoxetine 20 mg daily for 7 days Control group: Fluoxetine 20 mg daily plus placebo (Water + sugar)for 7 days The effect of Citrus Aurantium Sweat on anxiety in mothers with infants. Timepoint: Before the intervention and after the last day of the intervention. Method of measurement: The State-Trait Anxiet Inventory. The effect of orange spring sweat on the rate of sleep disorders in mothers with infants. Timepoint: Before the intervention and after the last day of the intervention. Method of measurement: General Sleep Disturbance Scale. Vice Chancellor for Research, Babol University of Medical Sciences Approved 2020-11-20 Ethics Committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganj Afrooz St. Babol Mazandaran Iran (Islamic Republic of)