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IRCT20151228025732N47 IRCT 2019-12-18 Semnan University of Medical Sciences Comparison of the effect of oral capsule and aroma of lavender on the quality of sleep in perimenopausal women Comparison of the effect of oral capsule and aroma of lavender on the quality of sleep in perimenopausal women 2019-11-19 anticipated 30 Complete https://irct.ir/trial/43695 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are allocated randomly with simple sequential allocation in one of the two study groups by help of sealed envelope and receive the intervention of the same group. The unit of randomization is patient. Sealed envelopes are delivered to expert. With each patient's visit, one of the envelopes is randomly selected by the patients and determines the study group. The stratification approach is not used. 0 (exploratory trials) Sleep. Intervention 1: Intervention group: Lavender essential oil with 100% concentration (Barij Herbal Medicines Company of Kashan) is placed on a 2x2 piece of gas when going to bed at night and attaches to the patient's collar. Intervention 2: Control group: 250 mg placebo capsule (brand name Linazepam) given to patients when going to bed at night. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Mohammadreza Asgari
Semnan University of Medical Sciences, Basij Blvd, Semnan
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3345 1336 asgari5000@gmail.com Semnan University of Medical Sciences scientific Mohammadreza Asgari
Semnan University of Medical Sciences, Basij Blvd, Semnan
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3345 1336 asgari5000@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Women aged 39-51 in transient menopausal period Healthy sense of smell No taking sleeping pills during the last month 39 years 51 years Female Drug addiction History of mental disorders History of asthma, bronchitis, chronic respiratory diseases F51.12 Insufficient sleep syndrome Treatment - Other Placebo Intervention group: Lavender essential oil with 100% concentration (Barij Herbal Medicines Company of Kashan) is placed on a 2x2 piece of gas when going to bed at night and attaches to the patient's collar. Control group: 250 mg placebo capsule (brand name Linazepam) given to patients when going to bed at night. Sleep Quality. Timepoint: Before intervention and after intervention (one month later). Method of measurement: PSQI- Pittsburgh Sleep Quality Index. Semnan University of Medical Sciences Approved 2019-11-19 Ethics committee of Semnan University of Medical Sciences Semnan University of Medical Sciences, Basij Blvd, Semnan Semnan Semnan Iran (Islamic Republic of)