Effect of IMB Model-Based Education for Women With Menopausal Hot Flashes

NCT07407907 | Active Not Recruiting

• 1 other identifier: 16.01.2024-06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Menopausal Hot Flashes

Keywords

Menopause; Hot Flashes; Vasomotor Symptoms; Health Education; IMB Model; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Hot Flash-Related Daily Interference

  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.

  Baseline (pre-intervention), 1 month, and 3 months

Secondary Outcomes (2)

• Hot Flush Beliefs

  Baseline (pre-intervention), 1 month, and 3 months

• Menopause-Specific Quality of Life

  Baseline (pre-intervention), 1 month, and 3 months

Study Arms (2)

IMB Model-Based Education Group

EXPERIMENTAL

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.

Behavioral: IMB Model-Based Education Program

Control Group (No Education)

NO INTERVENTION

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.

Interventions

IMB Model-Based Education Program BEHAVIORAL

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.

IMB Model-Based Education Group

Eligibility Criteria

• Age: 44 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Cumhuriyet University Health Services Application and Research Hospital, Obstetrics and Gynecology Outpatient Clinic

Sivas, Sivas, 58000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hot Flashes; Health Education

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Participants will be randomly assigned to either an intervention group receiving IMB model-based education or a control group receiving no intervention. Both groups will be followed at baseline, 1 month, and 3 months after baseline.

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: February 7, 2024
• Primary Completion: November 1, 2024
• Study Completion (Estimated): August 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)