Protocol summary
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Study aim
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This study aims to evaluate the effectiveness of a Mindfulness-Based Stress Reduction (MBSR) program on sexual distress and health-related quality of life among postmenopausal women.
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Design
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This is a randomized controlled trial (RCT) with a pre-test, post-test, and 3-month follow-up design.
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Settings and conduct
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The study will be conducted at health centers affiliated with Ahvaz Jundishapur University of Medical Sciences. Recruitment and intervention delivery will be carried out by trained facilitators under supervision.
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Participants/Inclusion and exclusion criteria
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Participants will be naturally postmenopausal women aged 47–62 years, with 1 to 5 years since their last menstrual period. Inclusion criteria include: a score >11 on the FSDS-R questionnaire, being married, no physical limitations for mindfulness practice, and no similar interventions in the past 6 months. Exclusion criteria include: acute or chronic illness affecting menopausal symptoms, recent major life stressors, hormone therapy in the past 6 months, substance abuse, use of antipsychotics, or engagement in professional physical activity.
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Intervention groups
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The intervention group will participate in eight weekly 90-minute sessions of MBSR training. The sessions include body scan, mindful breathing, yoga-based movements, and group discussion. The control group will receive no intervention during the study period.
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Main outcome variables
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Primary outcomes include changes in sexual distress (measured by FSDS-R) and health-related quality of life (measured by SF-36) from baseline to post-intervention and 3-month follow-up.
General information
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Reason for update
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Dear Respected Director,
At the end of 2015, due to my marriage, relocation from Ahvaz, subsequent pregnancy, the passing of my mother, and later my father's heart disease and surgery (along with the mild depression that naturally followed), I was unable to return to Ahvaz.
After my circumstances and emotional state improved, I was finally able to resume my work and sampling in Ahvaz in 2019.
Thank you for your understanding.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015121623344N2
Registration date:
2016-05-07, 1395/02/18
Registration timing:
prospective
Last update:
2025-07-31, 1404/05/09
Update count:
1
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Registration date
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2016-05-07, 1395/02/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice Chancellor for Research of Jundishapur University of Medical Science
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Expected recruitment start date
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2016-01-30, 1394/11/10
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Expected recruitment end date
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2016-06-30, 1395/04/10
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Actual recruitment start date
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2019-07-01, 1398/04/10
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Actual recruitment end date
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2019-12-01, 1398/09/10
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Trial completion date
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2019-12-01, 1398/09/10
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Scientific title
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The effect of mindfulness-based training on health related quality of life and female sexual distress in postmenopausal women
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Public title
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The effect of mindfulness-based training on health related quality of life and female sexual distress in postmenopausal women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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.
Exclusion criteria:
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.
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Age
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From 47 years old to 62 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Data analysts were blinded to group assignments.
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-01-23, 1394/11/03
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Ethics committee reference number
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IR.AJUMS.REC.1394. 564
Health conditions studied
1
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Description of health condition studied
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Menopause
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ICD-10 code
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N95.1
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ICD-10 code description
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Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause
Primary outcomes
1
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Description
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Health related quality of life
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Timepoint
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Before the intervention, Immediately after the intervention, Three months after the intervention completion
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Method of measurement
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Health related quality of life(SF36)
2
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Description
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Female sexual distress
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Timepoint
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Before the intervention, Immediately after the intervention, Three months after the intervention completion
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Method of measurement
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Female sexual distress scale(FSDS)
Secondary outcomes
1
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Description
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Physical functioning(PF)
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Timepoint
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Before the intervention, Immediately after the intervention, Three months after the intervention completion
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Method of measurement
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Questions 3 to 12 of SF36
2
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Description
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Role physical(RF)
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Timepoint
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Before the intervention, Immediately after the intervention, Three months after the intervention completion
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Method of measurement
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Questions 13 to 16 of SF36
3
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Description
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Role emotional(RE)
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Timepoint
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Before the intervention, Immediately after the intervention, Three months after the intervention completion
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Method of measurement
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Questions 17 to 19 of SF36
4
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Description
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Vitaity(VT)
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Timepoint
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Before the intervention, Immediately after the intervention, Three months after the intervention completion
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Method of measurement
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questions 23, 27, 29 and 31 of SF36
5
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Description
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Mental health(MH)
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Timepoint
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Before the intervention, Immediately after the intervention, Three months after the intervention completion
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Method of measurement
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questions 24, 25, 26, 28 and 30 of SF36
6
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Description
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Social functioning
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Timepoint
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Before the intervention, Immediately after the intervention, Three months after the intervention completion
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Method of measurement
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questions 20 and 32 of SF36
7
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Description
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Bodily pain(BP)
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Timepoint
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Before the intervention, Immediately after the intervention, Three months after the intervention completion
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Method of measurement
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questions 21 and 22 of SF36
8
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Description
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General health(GH)
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Timepoint
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Before the intervention, Immediately after the intervention, Three months after the intervention completion
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Method of measurement
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questions 1, 33 and 36 of SF36
9
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Description
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The Physical Component of Summary(PCS)
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Timepoint
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Before the intervention, Immediately after the intervention, Three months after the intervention completion
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Method of measurement
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PF+RF+BP+GH dimensions of SF36 Questionnaire
10
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Description
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The Mental Component Summary(MCS)
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Timepoint
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Before the intervention, Immediately after the intervention, Three months after the intervention completion
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Method of measurement
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SF+RE+MH+VT dimentions of SF36 Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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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.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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MARC-9407
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Science
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Concerning about data privacy
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available