NCT06582433

Brief Summary

This research will be conducted in a prospective pre-test post-test measurement randomized controlled experimental design. The population of the study consists of women who have entered menopause and live in Karabük. The research sample size was calculated considering the literature information that in experimental studies each group should consist of at least 30 individuals, taking into account the power of the test with G\*Power 3.1 Program. It was calculated that at least 32 observations are needed in both the experimental and control groups to reach a power level of 90% at a significance level of 5% with an effect size of 0.75, and the sample size of the study was calculated as 64 women. The data of the study will be collected using the "Personal Information Form", "Psychological Well-being Scale", "Menopausal Symptoms Evaluation Scale" and "Menopause Attitude Evaluation Scale". WORKFLOW Pre-procedure:

  • Women who meet the inclusion criteria for the study will be divided into experimental and control groups using simple randomization method.
  • Before the procedure, women in both groups will fill out the PIF, PWBS, MSES, and MAES (1st Measurement). During the procedure: At this stage, Solution-Focused Counseling (SFC) will be used on women in the experimental group by the researcher. SFC sessions for patients will be held individually, once a week, with a total of 6 sessions that may have deviations of 2-3 days before or after the previous session. Each session is planned to last 60 minutes. Counseling for patients will be conducted in a comfortable environment. At this stage, women in the control group will be given information on typical menopausal symptoms. Post-procedure: One week after the completion of SFC sessions, the PIF, PWBS, MSES, and MAES will be filled out by the experimental and control groups (2nd Measurement). Follow-up evaluation after 2 months: Two months after the completion of SFC sessions, the PIF, PWBS, MSES, and MAES will be applied to the experimental and control groups (Follow-up Measurement) to determine whether the results of the applied SFC are continuing.After monitoring measurements are taken on the control group, counseling will be provided to women according to their needs (addressing issues, answering questions, informing them according to their needs).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

August 28, 2024

Last Update Submit

July 31, 2025

Conditions

Keywords

MenopauseMenopausal SymptomsSolution-focused counseling

Outcome Measures

Primary Outcomes (1)

  • prevention

    Menopausal complaints

    One session per week, each session is 90 minutes, a total of 6 sessions.

Study Arms (2)

İntervention group

EXPERIMENTAL

Pre-Procedure: Women who meet the inclusion criteria will be divided into experimental and control groups using simple randomization method. Before the procedure, both groups will fill out the Personal Information Form (PIF), Psychological Well-being Scale (PWS), Menopausal Symptoms Assessment Scale (MSAS), and Menopause Attitude Assessment Scale(MASS) (1st Measurement). During the Procedure: Women in the experimental group will receive Solution-Focused Counseling (SFC) by the researcher. SFC will be conducted individually once a week, in a total of 6 sessions, with each session lasting 60 minutes. Post-Procedure: One week after the completion of SFC sessions, both groups will fill out PWS, MSAS, and MAAS again (2nd Measurement). Follow-Up Two Months Later: Two months later, both groups will fill out PWS, MSAS, and MAAS again to evaluate whether the effects of SFC are still present (Follow-Up Measurement).

Other: Intervention

Control group

NO INTERVENTION

Before the procedure, women will be asked to fill out a Personal Information Form (PIF), Psychological Well-being Scale (PWS), Menopause Symptoms Assessment Scale (MSAS), and Menopause Attitude Assessment Scale (MAAS) (1st Measurement). Women in the control group will be provided with information about routine menopausal symptoms. 2 months later, the 2nd Measurement will be taken. After the follow-up measurement is taken for the control group, counseling will be provided to women according to their needs (addressing problems, answering questions, providing information as needed).

Interventions

1. Process: implementation of pre-tests 2. Process: Solution-focused counseling, 60 minutes once a week for a total of 6 sessions 3. Final test after 2 months

Also known as: Experimental Group
İntervention group

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsperiod of menopause
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Accepting to participate in the study
  • Being a woman
  • Having been diagnosed with menopause for at least 1 year

You may not qualify if:

  • Leaving work halfway through without filling out surveys or scales even though you stayed to work
  • Having any barriers to communication
  • Having received a psychiatric diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, Karabük Province, 78050, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 28, 2024

First Posted

September 3, 2024

Study Start

September 1, 2024

Primary Completion

July 3, 2025

Study Completion

July 20, 2025

Last Updated

August 5, 2025

Record last verified: 2025-07

Locations