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Completed

NCT Number: NCT06979947

Effect of Structured Education on Menopause-Specific Quality of Life

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.

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Key information

Conditions

Menopause Quality of Life

Age range

45 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hasköy Family Health Center

Muş, CİTY, 49100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured Menopause Education Program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in MENQOL Subscale Scores (Vasomotor, Psychosocial, Physical, Sexual)

    Time frame: Baseline, 4 weeks, and 6 months

    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.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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