Menopausal WomenNCT07584109
The Effect of Value Clarification Based on Meleis's Transition Theory on Menopausal Symptoms, Depression, Anxiety, Stress, and Quality of Life in Perimenopausal Women
A study testing value clarification in people with Menopausal Women, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
Menopause is a life stage influenced not only by hormonal factors but also by psychological, social, and cultural factors. Symptoms such as hot flashes, sleep problems, and mood changes may occur, and their severity depends on how a woman perceives and copes with this period. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Women
- What is being tested?
- value clarification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2026to 4 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who agree to participate in the study,
- Have at least a primary school education,
- Understand, read, and write Turkish,
- Have no communication barriers,
- Are between 45-55 years of age,
- Have started experiencing menstrual cycle irregularities or have not menstruated,
Show all 9Show fewer
- Have experienced at least one menopausal symptom in the last 6 months (hot flashes, irritability, sleep problems, urogenital complaints, etc.),
- Are in the perimenopausal period according to the Straw Classification of Reproductive Aging in Women criteria,
- Women who have entered menopause naturally will be included in the study.
Who cannot join
- Women who:
- Use any complementary or alternative treatment methods (such as Reiki, phytoestrogens, acupressure),
- Use hypnotic or sedative medications,
- Have a diagnosed psychiatric illness,
- Have a gynecological problem causing menstrual irregularities,
- Have entered menopause as a result of any surgical operation such as a hysterectomy,
- Are receiving hormone replacement therapy will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Corum Private Hospital
Çorum, Centre, 19100
Neslihan KAZAK SALTAN, PhD, 05051059426, neslihankazak0369@hotmail.com
About this study
Menopause is a life stage influenced not only by hormonal factors but also by psychological, social, and cultural factors. Symptoms such as hot flashes, sleep problems, and mood changes may occur, and their severity depends on how a woman perceives and copes with this period.
The study aims to examine the effects of the "Value Clarification" method based on Meleis Transition Theory on menopausal symptoms, depression, anxiety, stress, and quality of life in women during menopause.
Read the detailed description
Menopause is a unique life event in a woman's life, influenced not only by physiological or hormonal factors, but also by cultural, psychological, and social factors. These changes that occur in a woman's life during menopause affect her quality of life, life satisfaction, and happiness.
Menopause is associated with vasomotor symptoms such as hot flashes and night sweats, musculoskeletal problems, sleep disturbances, urogenital changes, dyspareunia, sexual dysfunction, and mood swings. The number, severity, and impact of these symptoms on a woman's life depend on how she copes with this special period. A woman's perspective on the process is influenced by many factors. Being prepared for this period, not viewing it as the end of womanhood, and being aware of her own worth will reduce the degree to which she is negatively affected by menopause. Studies show that women who develop a positive attitude towards menopause experience milder symptoms. It can be said that there are limitations in the current system of care for the menopausal process in terms of changing the lack of information and negative perspectives on menopause.
In this context, this study aimed to examine the effects of Value Clarification, based on Meleis Transition Theory, on perimenopausal women's menopausal symptoms, depression, anxiety, stress levels, and menopause-specific quality of life.
- Conditions
- Menopausal Women
- Being tested
- value clarification, control group
- Keywords
- Menopause, Meleis Transition Theory, Value Clarification, depression, stress, anxiety, menopausal symptoms, quality of life, nursing
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
value clarificationOther
The intervention group will be given written clarification of values. After the pre-test, clarification will be applied once a month for 3 months, and the scales will be completed in the 3rd and 6th months.
control groupOther
The scales will be administered to the control group in parallel on the same dates.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: Value clarification group | Active comparator | The value clarification exercise will be administered to the intervention group once a month for three months. The results at the third and sixth months will be evaluated using scales. Receives: Other: value clarification |
| Control group: No intervention will be applied. | Active comparator | The control group will not receive the scales, but will be administered in parallel as a pre-test, at 3 months, and at 6 months. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in menopausal symptoms measured by the Menopausal Symptom Assessment Scale
The value explanation method based on transition theory improves menopausal symptoms in women when applied to perimenopausal women. The Menopausal Symptom Assessment Scale was developed to measure the severity of menopausal symptoms. The scale, adapted into Turkish, consists of 11 items and 3 sub-dimensions. These sub-dimensions are somatic complaints (items 1, 2, 3, and 11), psychological complaints (items 4, 5, 6, and 7), and urogenital complaints (items 8, 9, and 10). The Likert-type scale, which includes menopausal complaints, uses the options: 0: None, 1: Mild, 2: Moderate, 3: Severe, and 4: Very severe. The total score is calculated from the scores obtained from each item. The lowest possible score is "0," and the highest is "44." An increase in the total score indicates an increase in the severity of complaints and a negative impact on quality of life.
Measured: 0-6 month
Secondary outcomes (2)
Change in menopause-specific quality of life measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL)
Value clarification based on transition theory given to perimenopausal women improves their menopause-specific quality of life.
The scale, originally called the Menopause-Specific Quality of Life Questionnaire, was developed to assess the extent to which menopausal symptoms affect women's quality of life. The Turkish adaptation of is a Likert-type scale containing 29 questions. The scale consists of four sub-dimensions: Vasomotor (questions 1-3), Psychosocial (questions 4-10), Physical (questions 11-26), and Sexual (questions 27-29). Participants rate each symptom on a scale of 0-6, indicating its presence or absence. "NO" indicates the absence of the symptom, "PRESENT" or a score of 0 indicates the presence of the symptom, and a score of 1-6 indicates the severity and increasing degree of the existing problem.
Measured: 0-6 month
Changes in depression, anxiety, and stress levels that may be caused by mood swings during menopause were measured using the Depression Anxiety Stress Scale-21.
Depression, anxiety, and stress levels will be assessed using the Depression Anxiety Stress Scale-21, a validated self-report questionnaire consisting of 21 items divided into three subscales: depression, anxiety, and stress (7 items each).
Each item is scored on a 4-point Likert scale (0-3), where higher scores indicate greater symptom severity. Subscale scores are calculated by summing the relevant items, with possible scores ranging from 0 to 21 for each subscale.
Severity thresholds are defined as follows:
Depression: ≥14 indicates very severe depression Anxiety: ≥10 indicates very severe anxiety Stress: ≥17 indicates very severe stress
Measured: 0-6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start4 May 2026 (estimated)
- Primary completion4 Aug 2026 (estimated)
- Study completion4 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal WomenStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups: a value clarification group and a control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan KAZAK SALTAN, Ordu University
- Investigators
- Nülüfer ERBİL, Prof. Dr., Study director, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584109
- Sponsor's protocol ID
- OrduU-SBF-NKS-01
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Value Clarification Based on Meleis's Transition Theory on Menopausal Symptoms, Depression, Anxiety, Stress, and Quality of Life in Perimenopausal Women
- ClinicalTrials.gov ID
- NCT07584109
- Acronym / sponsor ID
- OrduU-SBF-NKS-01
- Conditions
- Menopausal Women
- Keywords
- Menopause, Meleis Transition Theory, Value Clarification, depression, stress, anxiety, menopausal symptoms, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 4 May 2026 (estimated)
- Primary completion
- 4 Aug 2026 (estimated)
- Study completion
- 4 Nov 2026 (estimated)
- First posted
- 13 May 2026 (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.
Menopause is a life stage influenced not only by hormonal factors but also by psychological, social, and cultural factors. Symptoms such as hot flashes, sleep problems, and mood changes may occur, and their severity depends on how a woman perceives and copes with this period.
The study aims to examine the effects of the "Value Clarification" method based on Meleis Transition Theory on menopausal symptoms, depression, anxiety, stress, and quality of life in women during menopause.
Detailed description
Menopause is a unique life event in a woman's life, influenced not only by physiological or hormonal factors, but also by cultural, psychological, and social factors. These changes that occur in a woman's life during menopause affect her quality of life, life satisfaction, and happiness.
Menopause is associated with vasomotor symptoms such as hot flashes and night sweats, musculoskeletal problems, sleep disturbances, urogenital changes, dyspareunia, sexual dysfunction, and mood swings. The number, severity, and impact of these symptoms on a woman's life depend on how she copes with this special period. A woman's perspective on the process is influenced by many factors. Being prepared for this period, not viewing it as the end of womanhood, and being aware of her own worth will reduce the degree to which she is negatively affected by menopause. Studies show that women who develop a positive attitude towards menopause experience milder symptoms. It can be said that there are limitations in the current system of care for the menopausal process in terms of changing the lack of information and negative perspectives on menopause.
In this context, this study aimed to examine the effects of Value Clarification, based on Meleis Transition Theory, on perimenopausal women's menopausal symptoms, depression, anxiety, stress levels, and menopause-specific quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two groups: a value clarification group and a control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Value clarification group | Active comparator | Other: value clarificationThe value clarification exercise will be administered to the intervention group once a month for three months. The results at the third and sixth months will be evaluated using scales. |
| Control group: No intervention will be applied. | Active comparator | Other: control groupThe control group will not receive the scales, but will be administered in parallel as a pre-test, at 3 months, and at 6 months. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Women who agree to participate in the study,
- Have at least a primary school education,
- Understand, read, and write Turkish,
- Have no communication barriers,
- Are between 45-55 years of age,
Key exclusion criteria (7 listed)
- Women who:
- Use any complementary or alternative treatment methods (such as Reiki, phytoestrogens, acupressure),
- Use hypnotic or sedative medications,
- Have a diagnosed psychiatric illness,
- Have a gynecological problem causing menstrual irregularities,
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 |
|---|---|---|
| value clarificationThe intervention group will be given written clarification of values. After the pre-test, clarification will be applied once a month for 3 months, and the scales will be completed in the 3rd and 6th months. | Other | Intervention group: Value clarification group |
| control groupThe scales will be administered to the control group in parallel on the same dates. | Other | Control group: No intervention will be applied. |
Primary outcome
Change in menopausal symptoms measured by the Menopausal Symptom Assessment Scale
Time frame: 0-6 month
The value explanation method based on transition theory improves menopausal symptoms in women when applied to perimenopausal women. The Menopausal Symptom Assessment Scale was developed to measure the severity of menopausal symptoms. The scale, adapted into Turkish, consists of 11 items and 3 sub-dimensions. These sub-dimensions are somatic complaints (items 1, 2, 3, and 11), psychological complaints (items 4, 5, 6, and 7), and urogenital complaints (items 8, 9, and 10). The Likert-type scale, which includes menopausal complaints, uses the options: 0: None, 1: Mild, 2: Moderate, 3: Severe, and 4: Very severe. The total score is calculated from the scores obtained from each item. The lowest possible score is "0," and the highest is "44." An increase in the total score indicates an increase in the severity of complaints and a negative impact on quality of life.
2 secondary outcomes
Change in menopause-specific quality of life measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL)
Time frame: 0-6 month
Changes in depression, anxiety, and stress levels that may be caused by mood swings during menopause were measured using the Depression Anxiety Stress Scale-21.
Time frame: 0-6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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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.
Nülüfer ERBİL, Prof. Dr. study director
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing value clarification in people with Menopausal Women, run by Ordu 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 9 inclusion and 7 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: opening soon, as of the sponsor's last update on 13 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neslihan KAZAK SALTAN, PhD (+905051059426, neslihankazak0369@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in menopausal symptoms measured by the Menopausal Symptom Assessment Scale (time frame: 0-6 month). 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 13 May 2026.