Effect of Structured Education on Menopause-Specific Quality of Life

Not Applicable

Completed

• Conditions: Menopause; Quality of Life

• Registration Number: NCT06979947
• Lead Sponsor: Inonu University

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.

Study Timeline

• Study Start: 2024-04-01
• Primary Completion: 2024-05-30
• Study Completion: 2024-11-30
• Status Verified: 2025-05
• Study First Submitted: 2025-05-10
• Study First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-18
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Menopause-Specific Quality of Life (MENQOL) Scores	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 Outcome Measures

Name	Time	Method
Change in MENQOL Subscale Scores (Vasomotor, Psychosocial, Physical, Sexual)	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.

Trial Locations

Locations (1)

Hasköy Family Health Center; 🇹🇷 MUŞ, Ci̇ty, Turkey