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

February 6, 2026 updated by: Yeliz ILDIR ALTUN, Marmara University

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Sivas
      • Sivas, Sivas, Turkey (Türkiye), 58000
        • Cumhuriyet University Health Services Application and Research Hospital, Obstetrics and Gynecology Outpatient Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

-

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: IMB Model-Based Education Program
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hot Flash-Related Daily Interference
Time Frame: Baseline (pre-intervention), 1 month, and 3 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Baseline (pre-intervention), 1 month, and 3 months
Menopause-Specific Quality of Life
Time Frame: Baseline (pre-intervention), 1 month, and 3 months
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.
Baseline (pre-intervention), 1 month, and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16.01.2024-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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