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IRCT20160427027633N4 IRCT 2018-08-12 Kermanshah University of Medical Sciences Effect of Salvia Officinalis aroma on sleep quality The effect of Salvia Officinalis aromatherapy on sleep quality in menopausal women 2018-09-23 anticipated 60 Complete https://irct.ir/trial/32756 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: This study, Simple randomization method is used for random allocation (hiding allocation). In this way, 60 cards matched in appearance are prepared and 30 of them have the number or code 1 that specifies the group "Intervention based on essence of Salvia Officinalis" and on 30 others of them the number or code 2 which specifies the control group(Distilled water ) is written. Then, each eligible person for inclusion in the study randomly takes one of these cards with the codes written on it. In this way, the random allocation of patients to each group is determined without letting the participants to know the nature of the numbers 1 or 2 in the type of intervention that will be assigned, Blinding description: In this study, to hide the allocation of aromas (essence of Salvia Officinalis) and placebo (Almond oil) Opaque envelopes sequentially numbered are used.Each envelope contains a glass of essence of Salvia Officinalis or placebo.Medications were placed on the envelope in the randomized allocation sequence by the person not involved in the study. Investigating individuals to study and delivering envelopes are done by the researcher himself from Nos. 1 to 60. In this study, blindness is not possible for the participant. Therefore, in this study, researcher and data analyzer blindness (lack of knowledge of the subject code) will be used, so the study will be double-blind. 3 Sleep quality. Intervention 1: Intervention group: The aromatherapy with essence of Salvia Officinalis with a concentration of 10% is made by the Vares Pharmaceutical Research Company. For 3 nights in a week, for one month, 2 drops of essence of Salvia Officinalis of that is in a dropper, on a cotton ball in the form of a neck pendant, and before Sleep is inhaled and removed from the neck after awakening. Intervention 2: Control group: The aromatherapy with almond oil with a concentration of 10% is made by the Vares Pharmaceutical Research Company. For 3 nights in a week, for one month, 2 drops of almond oil of that is in a dropper, on a cotton ball in the form of a neck pendant, and before Sleep is inhaled and removed from the neck after awakening. 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 I will decide after the end of the study.
public Foruzan Sharifipour
Amir Kabir Ave
Kermanshah Iran (Islamic Republic of) 6719917164 +98 83 3827 5239 sharifipour_fr91@yahoo.com Kermanshah University of Medical Sciences scientific Foruzan sharifipour
Amir Kabir Ave
Kermanshah Iran (Islamic Republic of) 6719917164 +98 83 3827 5239 sharifipour_fr91@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) ages 45 to 65 years old through at least one year since the last menstruation not having a history of allergic rhinitis and known respiratory problems such as asthma the absence of physical and mental illness non-use of drugs, tobacco and alcohol Non-occurrence of stressful incidents in the past six months 45 years 65 years Female the appearance of any physical and psychological illness during the study that causes sleep disorder the appearance of a significant change in sleep conditions unpredictably (divorce, death and travel) the sensation of Salvia aroma during the study Lack of the program performance for a maximum of one week during the study Rehabilitation Rehabilitation Intervention group: The aromatherapy with essence of Salvia Officinalis with a concentration of 10% is made by the Vares Pharmaceutical Research Company. For 3 nights in a week, for one month, 2 drops of essence of Salvia Officinalis of that is in a dropper, on a cotton ball in the form of a neck pendant, and before Sleep is inhaled and removed from the neck after awakening. Control group: The aromatherapy with almond oil with a concentration of 10% is made by the Vares Pharmaceutical Research Company. For 3 nights in a week, for one month, 2 drops of almond oil of that is in a dropper, on a cotton ball in the form of a neck pendant, and before Sleep is inhaled and removed from the neck after awakening. Sleep quality. Timepoint: Before and after the end of the intervention period. Method of measurement: Pittsburgh questionnaire. Complications. Timepoint: During the intervention. Method of measurement: Questionnaire made by the researcher. Kermanshah University of Medical Sciences Approved 2018-07-03 Ethics committee of Kermanshah University of Medical Sciences Shahid Beheshti Kermanshah Kermanshah Iran (Islamic Republic of)