- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07596368
THE EFFECT OF MOTIVATIONAL INTERVIEWING ON MENOPAUSE MYTHS AND POSTTRAUMATIC GROWTH IN POSTMENOPAUSAL WOMEN:RANDOMIZED CONTROLLED STUDY
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Menopause is a biological transition that may affect women physically, psychologically, and socially. Misconceptions regarding menopause may negatively influence adaptation to this period, while positive coping may support posttraumatic growth.
Motivational interviewing is a client-centered counseling approach designed to strengthen intrinsic motivation and promote positive behavioral change. This randomized controlled trial aims to determine the effect of motivational interviewing on menopause myths and posttraumatic growth in postmenopausal women.
The study will be conducted in Family Health Centers in Gaziantep, Turkey, with 96 postmenopausal women randomly assigned to intervention and control groups. The intervention group will receive four weekly face-to-face motivational interviewing sessions lasting 30-45 minutes. The control group will receive usual care without intervention.
Data will be collected at baseline and after intervention using the Menopause Myths Scale and the Posttraumatic Growth Scale.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women who have had their last menstrual period between 12 and 36 months ago,
- are literate,
- can read and write in Turkish,
- do not have any problems that may hinder communication, and
- do not have any diagnosed psychiatric illness will be included in the study.
Exclusion Criteria:
- Those receiving HRT treatment,
- Those whose last menstrual period was 36 months or more ago,
- Women receiving oncology treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
No intervention
|
|
|
Experimental: intervention group
The researcher provided training on motivational interviewing techniques to be applied to the experimental group prior to the intervention.
Women were informed about the research, and those wishing to participate were given a voluntary information form to read, and their verbal and written consent was obtained.
Before starting the Motivational Interview sessions, the client was informed about the duration, number, and timing of the sessions.
Each motivational interview session with the women in the experimental group is planned to last approximately 30-45 minutes.
A total of four motivational interview sessions will be conducted with the women in the experimental group, once a week.
All sessions will be conducted by inviting the women to their family physician's office.
During the motivational interview sessions, counseling will be provided on topics related to the menopausal period, aiming to change negative beliefs about menopause myths and increase post-traumatic growth levels.
|
The researcher provided training on motivational interviewing techniques to be applied to the experimental group prior to the intervention.
Women will be informed about the research, and those wishing to participate will be given a voluntary information form to read, and their verbal and written consent will be obtained.
The client will be informed about the duration, number, and timing of the interviews before the start of the MG sessions.
Each motivational interview session with the women in the experimental group is planned to last approximately 30-45 minutes.
A total of four MG sessions will be conducted with the women in the experimental group, once a week.
All sessions will be conducted by inviting the women to their family physician's office.
During the MG sessions, counseling will be provided on topics related to the menopausal period in order to change the women's negative beliefs about menopause myths and to increase their post-traumatic growth levels after menopause.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MENOPAUSE MYTHS SCALE
Time Frame: At the beginning and at the end of the 4-week intervention period
|
Women's perceptions of menopause were measured using the Menopause Myths Scale.
|
At the beginning and at the end of the 4-week intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-Traumatic Growth Scale
Time Frame: At the beginning and at the end of the 4-week intervention period
|
The Post-Traumatic Growth Scale was used to assess the extent to which menopause creates trauma in women's lives.
|
At the beginning and at the end of the 4-week intervention period
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 860686
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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