MenopauseNCT06582433
Solution-focused Counseling for Menopausal Symptoms
A study testing Intervention in people with Menopause and Menopause Related Conditions, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Menopause Related Conditions, Menopausal Depression
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 20 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Accepting to participate in the study
- Being a woman
- Having been diagnosed with menopause for at least 1 year
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabuk University
Karabük, Karabük Province, 78050
About this study
Official title: The Effectiveness of Solution-Focused Counseling in Managing Menopausal Symptoms
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
Read more
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).
Read the detailed description
The aim of this research is to examine the effectiveness of solution-focused counseling in managing menopausal symptoms and to investigate the impact of this approach on the attitudes and psychological well-being of women in the menopausal period.
H1: Solution-focused counseling affects the evaluation of menopausal symptoms in women in the menopausal period.
H2: Solution-focused counseling leads to changes in attitudes towards menopause in women in the menopausal period.
H3: Solution-focused counseling affects the level of psychological well-being of women in the menopausal period.
- Being tested
- Intervention
- Keywords
- Menopause, Menopausal Symptoms, Solution-focused counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Also called Experimental Group
- Process: implementation of pre-tests
- Process: Solution-focused counseling, 60 minutes once a week for a total of 6 sessions
- Final test after 2 months
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention
Menopausal complaints
Measured: One session per week, each session is 90 minutes, a total of 6 sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Sep 2024
- Primary completion3 Jul 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Cuvadar, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582433
- Sponsor's protocol ID
- E-77192459-050.99-338559
- Status last verified
- Jul 2025
- First submitted
- 28 Aug 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Solution-Focused Counseling in Managing Menopausal Symptoms
- ClinicalTrials.gov ID
- NCT06582433
- Acronym / sponsor ID
- E-77192459-050.99-338559
- Keywords
- Menopause, Menopausal Symptoms, Solution-focused counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The aim of this research is to examine the effectiveness of solution-focused counseling in managing menopausal symptoms and to investigate the impact of this approach on the attitudes and psychological well-being of women in the menopausal period.
H1: Solution-focused counseling affects the evaluation of menopausal symptoms in women in the menopausal period.
H2: Solution-focused counseling leads to changes in attitudes towards menopause in women in the menopausal period.
H3: Solution-focused counseling affects the level of psychological well-being of women in the menopausal period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention group | Experimental | Other: InterventionPre-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). |
| 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). |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Accepting to participate in the study
- Being a woman
- Having been diagnosed with menopause for at least 1 year
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAlso: Experimental Group1. 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 | Other | İntervention group |
Primary outcome
prevention
Time frame: One session per week, each session is 90 minutes, a total of 6 sessions.
Menopausal complaints
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
Related trials for Menopause
RecruitingObservational study
Health, Imaging, and Cognition Across the Menopausal Transition
Menopause
RecruitingObservational study
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
Acute Ovarian Failure, Infertility
Not yet recruiting
Waning Moon: A Whole Person Health Intervention Designed by and for Urban Menopausal American Indian/Alaska Native Women
Menopause, Vasomotor Symptoms (VMS)
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
RecruitingObservational study
QoLIDia: Quality of Life in Cancer Patients With Diabetes During Immunotherapy
Cancer, Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Menopause and Menopause Related Conditions, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention (time frame: One session per week, each session is 90 minutes, a total of 6 sessions.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.