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IRCT2015121623344N2 IRCT 2016-05-07 Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Science The effect of mindfulness-based training on health related quality of life and female sexual distress in postmenopausal women The effect of mindfulness-based training on health related quality of life and female sexual distress in postmenopausal women 2016-01-30 anticipated 60 Complete https://irct.ir/trial/19928 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Participants were randomly assigned to either the intervention or control group using permuted block randomization with varying block sizes of 4, 6, and 8. Due to the nature of the intervention, blinding of participants and facilitators was not possible. However data analysts were blinded to group assignments, Blinding description: Data analysts were blinded to group assignments. N/A Menopause. Intervention 1: Intervention group: According to MBSR protocol (Jon Kabat-Zinn, 2014) mindfulness training will be performed just once a week, in 120 minutes and during 8 sessions for each of 5 groups. Intervention 2: Control group: Because of ethical considerations, mindfulness training will be performed in 2 sessions, three months after the intervention and at the end of three stages of evaluation. No - There is not a plan to make this available Justification or reason for not sharing IPD is Concerning about data privacy
public Masoomeh Yazdani Aliabadi
Jalal AleAhmad, Nasr bridge
Tehran Iran (Islamic Republic of) - 00 yazdani.mw89@gmail.com Tarbiat Modares University scientific Dr. Mojgan Javadnoori
Golestan Blvd, Golestane Enghelab Dormitory of Jundishpur University of Medical Science
Ahvaz Iran (Islamic Republic of) - - mozhganjavadnoori@yahoo.com Ahvaz Jundishapur University of Medical Science Iran (Islamic Republic of) Iran (Islamic Republic of) Eligible participants were naturally postmenopausal women aged 47–62 years, with 1 to 5 years since their last menstrual period. Additional inclusion criteria were: a score >11 on the FSDS-R questionnaire during pretest screening, being married, having no physical limitations for performing mindfulness exercises, and no prior participation in similar interventions within the previous six months. 47 years 62 years Female Exclusion criteria included: presence of acute or chronic diseases or conditions affecting menopausal symptoms (e.g., thyroid disorders, cognitive impairment), recent adverse life events (within six months), use of hormone replacement therapy or topical estrogens (within six months), alcohol or drug abuse, antipsychotic medication use, and professional physical activity. Participants who missed more than two sessions, experienced a major stressor during the intervention, or expressed unwillingness to continue were withdrawn from the study. N95.1 Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause Behavior Behavior Intervention group: According to MBSR protocol (Jon Kabat-Zinn, 2014) mindfulness training will be performed just once a week, in 120 minutes and during 8 sessions for each of 5 groups. Control group: Because of ethical considerations, mindfulness training will be performed in 2 sessions, three months after the intervention and at the end of three stages of evaluation. Health related quality of life. Timepoint: Before the intervention, Immediately after the intervention, Three months after the intervention completion. Method of measurement: Health related quality of life(SF36). Female sexual distress. Timepoint: Before the intervention, Immediately after the intervention, Three months after the intervention completion. Method of measurement: Female sexual distress scale(FSDS). Physical functioning(PF). Timepoint: Before the intervention, Immediately after the intervention, Three months after the intervention completion. Method of measurement: Questions 3 to 12 of SF36. Role physical(RF). Timepoint: Before the intervention, Immediately after the intervention, Three months after the intervention completion. Method of measurement: Questions 13 to 16 of SF36. Role emotional(RE). Timepoint: Before the intervention, Immediately after the intervention, Three months after the intervention completion. Method of measurement: Questions 17 to 19 of SF36. Vitaity(VT). Timepoint: Before the intervention, Immediately after the intervention, Three months after the intervention completion. Method of measurement: questions 23, 27, 29 and 31 of SF36. Mental health(MH). Timepoint: Before the intervention, Immediately after the intervention, Three months after the intervention completion. Method of measurement: questions 24, 25, 26, 28 and 30 of SF36. Social functioning. Timepoint: Before the intervention, Immediately after the intervention, Three months after the intervention completion. Method of measurement: questions 20 and 32 of SF36. Bodily pain(BP). Timepoint: Before the intervention, Immediately after the intervention, Three months after the intervention completion. Method of measurement: questions 21 and 22 of SF36. General health(GH). Timepoint: Before the intervention, Immediately after the intervention, Three months after the intervention completion. Method of measurement: questions 1, 33 and 36 of SF36. The Physical Component of Summary(PCS). Timepoint: Before the intervention, Immediately after the intervention, Three months after the intervention completion. Method of measurement: PF+RF+BP+GH dimensions of SF36 Questionnaire. The Mental Component Summary(MCS). Timepoint: Before the intervention, Immediately after the intervention, Three months after the intervention completion. Method of measurement: SF+RE+MH+VT dimentions of SF36 Questionnaire. Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Science Approved 2016-01-23 Ahvaz Jundishapur University of Medical Science Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)