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Effect of Structured Education on Menopause-Specific Quality of Life

Effect of Structured Education on Menopause-Specific Quality of Life

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06979947
Enrollment
101
Registered
2025-05-20
Start date
2024-04-01
Completion date
2024-11-30
Last updated
2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause, Quality of Life

Keywords

Menopause, Structured Education, Midwifery, MENQOL, Women's Health

Brief 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.

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.

Interventions

BEHAVIORALStructured Menopause Education Program

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.

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

The study was not blinded; both participants and investigators were aware of group assignments.

Intervention model description

Participants were assigned to either an intervention group receiving structured education or a control group receiving no intervention.

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* • 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

Exclusion criteria

* 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 * Lost to follow-up at 6 months * Developed a new health issue affecting menopause * Participated in other menopause interventions * Incomplete or inconsistent questionnaire

Design outcomes

Primary

MeasureTime frameDescription
Change in Menopause-Specific Quality of Life (MENQOL) ScoresBaseline (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.

Secondary

MeasureTime frameDescription
Change in MENQOL Subscale Scores (Vasomotor, Psychosocial, Physical, Sexual)Baseline, 4 weeks, and 6 monthsComparison 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026