Effect of Structured Education on Menopause-Specific Quality of Life

NCT ID: NCT06979947

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-11-30

Brief Summary

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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

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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

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Menopause Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

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

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

Structured Menopause Education Program

Intervention Type 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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Structured 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Tuba Enise BENLI

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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KADER ATABEY

Role: PRINCIPAL_INVESTIGATOR

Inonu University

Locations

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Hasköy Family Health Center

Muş, CİTY, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

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