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Not yet recruitingNCT07584109Updated May 13, 2026

The Effect of Value Clarification Based on Meleis's Transition Theory on Menopausal Symptoms, Depression, Anxiety, Stress, and Quality of Life in Perimenopausal Women

An interventional study of value clarification and control group in Menopausal Women, sponsored by Ordu University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 45 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by Ordu University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
45 Years to 55 Years
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Menopausal Women

Keywords

  • Menopause
  • Meleis Transition Theory
  • Value Clarification
  • depression
  • stress
  • anxiety
  • menopausal symptoms
  • quality of life
  • nursing
03

Who can participate

Ages eligible
45 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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,
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
88 participants (estimated)

Study arms

  • Active comparator
    Intervention group: Value clarification group

    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.

    Other: value clarification

  • Active comparator
    Control group: No intervention will be applied.

    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.

    Other: control group

Interventions

  • Othervalue clarification

    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.

  • Othercontrol group

    The scales will be administered to the control group in parallel on the same dates.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0-6 month

Secondary outcomes

  1. 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.

    Time frame: 0-6 month

  2. 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

    Time frame: 0-6 month

06

Study locations

1 site
  • Corum Private Hospital
    Çorum, Centre 19100, Turkey (Türkiye)
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07584109
Lead sponsor
Ordu University
Responsible party
Neslihan KAZAK SALTAN (Student, Ordu University) — Principal investigator
First posted
May 13, 2026
Start date
May 4, 2026 (estimated)
Primary completion
Aug 4, 2026 (estimated)
Completion
Nov 4, 2026 (estimated)
Last update
May 13, 2026

Study contacts

Neslihan KAZAK SALTAN, PhD
Contact
neslihankazak0369@hotmail.com
+905051059426
Nülüfer ERBİL, Prof. Dr.
study director · Ordu University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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