MenopauseNCT06979947
Effect of Structured Education on Menopause-Specific Quality of Life
A study testing Structured Menopause Education Program in people with Menopause and Quality of Life, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the impact of a structured education program delivered under midwife guidance on menopause-specific quality of life among women aged 45-55 undergoing natural menopause, and to assess the sustainability of its effects over time. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Menopause, Quality of Life
- What is being tested?
- Structured Menopause Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Women aged 45-55
- Experiencing natural (non-surgical) menopause
- Literate and able to complete questionnaires
- No neurological or cognitive impairments
- Willing to participate and attend sessions
- Has access to phone/internet
Who cannot join
- Surgical menopause
- Hormonal disorders causing amenorrhea
- Current use of hormonal therapy or antidepressants
- Diagnosed psychiatric conditions
- Removal Criteria (if applicable):
- Did not attend at least 80% of sessions
Show all 10Show fewer
- Lost to follow-up at 6 months
- Developed a new health issue affecting menopause
- Participated in other menopause interventions
- Incomplete or inconsistent questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the impact of a structured education program delivered under midwife guidance on menopause-specific quality of life among women aged 45-55 undergoing natural menopause, and to assess the sustainability of its effects over time.
Read the detailed description
This randomized controlled longitudinal study was conducted with 101 women aged 45-55 experiencing natural menopause (intervention: 51, control: 50). The intervention group received a structured menopause education program developed based on literature and expert review. Data were collected using a Personal Information Form and the Menopause-Specific Quality of Life Questionnaire (MENQOL) at three time points: baseline (T1), after education (T2), and six months later (T3). The intervention consisted of four weekly face-to-face sessions delivered by a midwife. The education content included information on menopausal changes, symptoms, and coping strategies. The control group received no intervention during the study but received educational material after final data collection. Data were analyzed using SPSS 20.0 with p<0.05 considered statistically significant.
- Conditions
- Menopause, Quality of Life
- Being tested
- Structured Menopause Education Program
- Keywords
- Menopause, Structured Education, Midwifery, MENQOL, Women's Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Menopause Education ProgramBehavioural
The structured education program was developed by midwifery researchers and delivered face-to-face by a certified midwife over four weekly sessions. Each session lasted approximately 20-25 minutes and covered topics such as menopausal symptoms, lifestyle changes, and coping strategies. Educational materials were individualized based on participants' MENQOL pre-test scores.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants received a structured menopause education program delivered by a midwife. The program consisted of four weekly sessions, each lasting 20-25 minutes, covering menopause-related symptoms, physiological changes, and coping strategies. Educational materials were developed by the researchers and validated by experts. The education was tailored based on participants' MENQOL pre-test scores. Receives: Behavioral: Structured Menopause Education Program |
| Control Group | No intervention | Participants received no intervention during the study. They completed the same assessments at the same time points as the intervention group. After final data collection, the educational material was shared with them to ensure equity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Menopause-Specific Quality of Life (MENQOL) Scores
Mean change in total and subscale scores of the Menopause-Specific Quality of Life Questionnaire (MENQOL) from baseline to 6-month follow-up. Higher scores indicate greater symptom severity and lower quality of life.The MENQOL total score ranges from 0 to 6. Higher scores indicate greater symptom severity and lower quality of life.
Measured: Baseline (T1), 4 weeks after intervention (T2), and 6 months after intervention (T3)
Secondary outcomes (1)
Change in MENQOL Subscale Scores (Vasomotor, Psychosocial, Physical, Sexual)
Comparison of MENQOL subscale scores between intervention and control groups at each time point. Subscales include vasomotor, psychosocial, physical, and sexual symptoms.Each MENQOL subscale (vasomotor, psychosocial, physical, sexual) has items scored from 0 to 6. Higher scores reflect more severe symptoms.
Measured: Baseline, 4 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Apr 2024
- Primary completion30 May 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to either an intervention group receiving structured education or a control group receiving no intervention.
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Enise BENLI, Inonu University
- Investigators
- KADER ATABEY, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979947
- Status last verified
- May 2025
- First submitted
- 10 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Structured Education on Menopause-Specific Quality of Life
- ClinicalTrials.gov ID
- NCT06979947
- Conditions
- Menopause, Quality of Life
- Keywords
- Menopause, Structured Education, Midwifery, MENQOL, Women's Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 20 May 2025 (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 aims to evaluate the impact of a structured education program delivered under midwife guidance on menopause-specific quality of life among women aged 45-55 undergoing natural menopause, and to assess the sustainability of its effects over time.
Detailed description
This randomized controlled longitudinal study was conducted with 101 women aged 45-55 experiencing natural menopause (intervention: 51, control: 50). The intervention group received a structured menopause education program developed based on literature and expert review. Data were collected using a Personal Information Form and the Menopause-Specific Quality of Life Questionnaire (MENQOL) at three time points: baseline (T1), after education (T2), and six months later (T3). The intervention consisted of four weekly face-to-face sessions delivered by a midwife. The education content included information on menopausal changes, symptoms, and coping strategies. The control group received no intervention during the study but received educational material after final data collection. Data were analyzed using SPSS 20.0 with p<0.05 considered statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to either an intervention group receiving structured education or a control group receiving no intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Structured Menopause Education ProgramParticipants received a structured menopause education program delivered by a midwife. The program consisted of four weekly sessions, each lasting 20-25 minutes, covering menopause-related symptoms, physiological changes, and coping strategies. Educational materials were developed by the researchers and validated by experts. The education was tailored based on participants' MENQOL pre-test scores. |
| Control Group | No intervention | –Participants received no intervention during the study. They completed the same assessments at the same time points as the intervention group. After final data collection, the educational material was shared with them to ensure equity. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Women aged 45-55
Key exclusion criteria (10 listed)
- Surgical menopause
- Hormonal disorders causing amenorrhea
- Current use of hormonal therapy or antidepressants
- Diagnosed psychiatric conditions
- Did not attend at least 80% of sessions
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 |
|---|---|---|
| Structured Menopause Education ProgramThe structured education program was developed by midwifery researchers and delivered face-to-face by a certified midwife over four weekly sessions. Each session lasted approximately 20-25 minutes and covered topics such as menopausal symptoms, lifestyle changes, and coping strategies. Educational materials were individualized based on participants' MENQOL pre-test scores. | Behavioural | Intervention Group |
Primary outcome
Change in Menopause-Specific Quality of Life (MENQOL) Scores
Time frame: Baseline (T1), 4 weeks after intervention (T2), and 6 months after intervention (T3)
Mean change in total and subscale scores of the Menopause-Specific Quality of Life Questionnaire (MENQOL) from baseline to 6-month follow-up. Higher scores indicate greater symptom severity and lower quality of life.The MENQOL total score ranges from 0 to 6. Higher scores indicate greater symptom severity and lower quality of life.
1 secondary outcome
Change in MENQOL Subscale Scores (Vasomotor, Psychosocial, Physical, Sexual)
Time frame: Baseline, 4 weeks, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD).
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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.
KADER ATABEY principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Menopause Education Program in people with Menopause and Quality of Life, run by Inonu 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 20 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Menopause-Specific Quality of Life (MENQOL) Scores (time frame: Baseline (T1), 4 weeks after intervention (T2), and 6 months after intervention (T3)). 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 20 May 2025.