Menopausal Hot FlashesIMBNCT07407907
Effect of IMB Model-Based Education for Women With Menopausal Hot Flashes
A study testing IMB Model-Based Education Program in people with Menopausal Hot Flashes, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 44 to 60 years, women only
- Conditions the study is for
- Menopausal Hot Flashes
- What is being tested?
- IMB Model-Based Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2024to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- -
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cumhuriyet University Health Services Application and Research Hospital, Obstetrics and Gynecology Outpatient Clinic
Sivas, Sivas, 58000
About this study
Official title: 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.
- Conditions
- Menopausal Hot Flashes
- Being tested
- IMB Model-Based Education Program
- Keywords
- Menopause, Hot Flashes, Vasomotor Symptoms, Health Education, IMB Model, Quality of Life
- Medical subject headings
- Hot Flashes, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMB Model-Based Education ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-intervention), 1 month, and 3 months
Secondary outcomes (2)
Hot Flush Beliefs
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.
Measured: Baseline (pre-intervention), 1 month, and 3 months
Menopause-Specific Quality of Life
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.
Measured: Baseline (pre-intervention), 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start7 Feb 2024
- Primary completion1 Nov 2024
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal Hot FlashesStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz ILDIR ALTUN, Marmara University
- Investigators
- Hatice YILDIZ, Prof.Dr., Principal investigator, Marmara University, Faculty of Health Sciences, Department of Obstetrics and Gynecology Nursing, Basıbuyuk RTE Health and Education Campus, 34854-Maltepe- Istanbul, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407907
- Sponsor's protocol ID
- 16.01.2024-06
- Acronym
- IMB
- Status last verified
- Jan 2026
- First submitted
- 6 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Education Provided Based on the Information-Motivation-Behavioral Skills Model in Women Experiencing Hot Flashes During Menopause
- ClinicalTrials.gov ID
- NCT07407907
- Acronym / sponsor ID
- IMB / 16.01.2024-06
- Conditions
- Menopausal Hot Flashes
- Keywords
- Menopause, Hot Flashes, Vasomotor Symptoms, Health Education, IMB Model, Quality of Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| IMB Model-Based Education Group | Experimental | Behavioral: IMB Model-Based Education ProgramA 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. |
| 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. |
Who may qualify
- Ages
- 44 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMB Model-Based Education ProgramA 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. | Behavioural | IMB Model-Based Education Group |
Primary outcome
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.
2 secondary outcomes
Hot Flush Beliefs
Time frame: Baseline (pre-intervention), 1 month, and 3 months
Menopause-Specific Quality of Life
Time frame: Baseline (pre-intervention), 1 month, and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Menopausal Hot Flashes
RecruitingPhase 2/3
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Menopause, Menopause Hot Flashes
RecruitingPhase 3
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
Hot Flashes
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatice YILDIZ, Prof.Dr. principal investigator
Marmara University, Faculty of Health Sciences, Department of Obstetrics and Gynecology Nursing, Basıbuyuk RTE Health and Education Campus, 34854-Maltepe- Istanbul, Türkiye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMB Model-Based Education Program in people with Menopausal Hot Flashes, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hot Flash-Related Daily Interference (time frame: Baseline (pre-intervention), 1 month, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.