Effect of Structured Education on Menopause-Specific Quality of Life

NCT06979947 | Completed

• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Quality of Life

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline, 4 weeks, and 6 months

Study Arms (2)

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.

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.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Hasköy Family Health Center

Muş, CİTY, 49100, Turkey (Türkiye)

Location

Study Officials

• KADER ATABEY

  Inonu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study was not blinded; both participants and investigators were aware of group assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: May 20, 2025
• Study Start: April 1, 2024
• Primary Completion: May 30, 2024
• Study Completion: November 30, 2024
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)