Clinical trial NCT06979947: Effect of Structured Education on Menopause-Specific Quality of Life
Official title: Effect of Structured Education on Menopause-Specific Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Quality of Life
Keywords: Menopause
Structured Education
Midwifery
MENQOL
Women's Health
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 101
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were assigned to either an intervention group receiving structured education or a control group receiving no intervention.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Menopause-Specific Quality of Life (MENQOL) Scores
timeFrame: Baseline (T1), 4 weeks after intervention (T2), and 6 months after intervention (T3)
Secondary outcomes:
measure: Change in MENQOL Subscale Scores (Vasomotor, Psychosocial, Physical, Sexual)
timeFrame: Baseline, 4 weeks, and 6 months
Other outcomes:
Locations:
city: MUŞ
country: Turkey
facility: Hasköy Family Health Center
state: Ci̇ty
Study officials:
affiliation: Inonu University
name: KADER ATABEY
role: PRINCIPAL_INVESTIGATOR
References: