- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07407907
Effect of IMB Model-Based Education for Women With Menopausal Hot Flashes (IMB)
The Effect of the Education Provided Based on the Information-Motivation-Behavioral Skills Model in Women Experiencing Hot Flashes During Menopause
This study was conducted to examine the effect of an education program based on the Information-Motivation-Behavioral Skills (IMB) Model on the level of hot flashes, overall menopausal symptoms, and quality of life in women experiencing hot flashes during the menopausal period.
The study consisted of an intervention group and a control group. The intervention group received a structured education program based on the IMB Model, while no education, counseling, or care intervention was provided to the control group. Both groups were assessed at baseline, and at the 1st and 3rd months following the intervention.
It is expected that the findings obtained from this study will demonstrate the effectiveness of IMB Model-based education in the management of menopausal vasomotor symptoms and contribute to the development of evidence-based nursing practices for women during the menopausal period.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sivas
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Sivas, Sivas, Turkey (Türkiye), 58000
- Cumhuriyet University Health Services Application and Research Hospital, Obstetrics and Gynecology Outpatient Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:Women aged between 44 and 60 years.
Women in the perimenopausal or postmenopausal period.
A score of ≥ 10 on the Menopause-Specific Hot Flash Scale.
No diagnosis of severe chronic disease and no regular medication use related to such conditions.
Not receiving Hormone Replacement Therapy (HRT).
No diagnosed mental disorder requiring medical treatment.
Able to read, write, speak, and understand Turkish, with no language barriers.
Willingness to participate in the study and provision of voluntary informed consent.
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Exclusion Criteria:Not meeting the inclusion criteria.
Initiation of Hormone Replacement Therapy during the study period.
Refusal to participate in the study.
Occurrence of an unexpected acute illness during the study period.
Withdrawal from the study at any stage by personal choice.
Incomplete completion of study questionnaires or forms after enrollment.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: IMB Model-Based Education Group
A structured education program based on the Information-Motivation-Behavioral Skills (IMB) model was provided to women experiencing hot flashes during the menopausal period.
The education program included information on the physiology of hot flashes, symptom management, lifestyle modifications, coping strategies, and the development of behavioral skills to manage menopausal symptoms.
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A structured education program based on the Information-Motivation-Behavioral Skills (IMB) model was delivered to women experiencing hot flashes during menopause.
The intervention aimed to enhance participants' knowledge, motivation, and behavioral skills related to the management of menopausal hot flashes.
The educational content included information on the physiology of hot flashes, lifestyle modifications, symptom management strategies, coping techniques, and skills to support healthy behaviors.
The program was delivered through planned educational sessions.
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|
No Intervention: Control Group (No Education)
This group consisted of women experiencing hot flashes during the menopausal period who did not receive any education or intervention during the study period.
Participants continued their usual daily routines.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hot Flash-Related Daily Interference
Time Frame: Baseline (pre-intervention), 1 month, and 3 months
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Hot flash-related daily interference was assessed using the Hot Flash Related Daily Interference Scale, which evaluates the extent to which hot flashes interfere with daily activities and quality of life.
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Baseline (pre-intervention), 1 month, and 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hot Flush Beliefs
Time Frame: Baseline (pre-intervention), 1 month, and 3 months
|
Hot flush-related beliefs were assessed using the Hot Flush Beliefs Scale (HFBS), which evaluates women's cognitive beliefs and perceptions related to hot flashes.
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Baseline (pre-intervention), 1 month, and 3 months
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Menopause-Specific Quality of Life
Time Frame: Baseline (pre-intervention), 1 month, and 3 months
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Menopause-specific quality of life was assessed using the Menopause-Specific Quality of Life Scale, which evaluates the impact of menopausal symptoms on women's physical, psychological, and social well-being.
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Baseline (pre-intervention), 1 month, and 3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hatice YILDIZ, Prof.Dr., Marmara University, Faculty of Health Sciences, Department of Obstetrics and Gynecology Nursing, Basıbuyuk RTE Health and Education Campus, 34854-Maltepe- Istanbul, Türkiye
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
- 16.01.2024-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Menopausal Hot Flashes
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