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IRCT20160427027633N11 IRCT 2024-06-14 Kermanshah University of Medical Sciences Comparison of the effect of lavender and Salvia Officinalis aroma on the sleep quality Comparison of the effect of lavender and Salvia Officinalis aroma on the sleep quality of postmenopausal women 2024-06-20 anticipated 159 Complete https://irct.ir/trial/77159 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Allocation of subjects to study groups (two intervention groups and one control group) will be done by block randomization method and using blocks of 6. This will be done with WinPepi11.0 software. This software generates random groups. In each block, 2 subjects will belong to the control group, 2 subjects will belong to the intervention group with salvia and 2 subjects will belong to the intervention group with lavender, and their order will be random. We will have 26 blocks of 6 and one block of 3 with ratio of 1:1:1, Blinding description: 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. N/A 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: Intervention group: The aromatherapy with essence of Lavender 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 3: 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
Isar Square, Daulat Abad Blvd
Kermanshah Iran (Islamic Republic of) 6719816593 +98 83 3828 2101 sharifipour_fr91@yahoo.com Kermanshah University of Medical Sciences scientific Susan Heydarpour
Dolat Abad, Isar Square
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3828 2101 s.heydarpour1394@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Acquiring the sleep quality questionnaire score ≥ 5 Through at least one year since the last menstruation Having enough literacy to fill out a questionnaire Age of at least 45 years 45 years 65 years Female Occurrence of stressful incidents in the past six months Use of drugs, tobacco and alcohol Physical and mental illness Sensitivity to lavender, Salvia Officinalis and almond oil History of allergic rhinitis and known respiratory problems such as asthma Rehabilitation Rehabilitation Placebo 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 group: The aromatherapy with essence of Lavender 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: Sleep quality questionnaire of Pittsburgh. Complications(dyspnea, headache, dizziness, nausea and vomiting). Timepoint: During the intervention. Method of measurement: Questionnaire made by the researcher. Kermanshah University of Medical Sciences Approved 2024-05-27 Ethics committee of Kermanshah University of Medical Sciences Shahid Beheshti Kermanshah Kermanshah South Africa