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

6 mei 2026 bijgewerkt door: Neslihan KAZAK SALTAN, Ordu University

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

88

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Ander: value 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.
Actieve vergelijker: 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.
Ander: control group
The scales will be administered to the control group in parallel on the same dates.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in menopausal symptoms measured by the Menopausal Symptom Assessment Scale
Tijdsspanne: 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.
0-6 month

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in menopause-specific quality of life measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL)
Tijdsspanne: 0-6 month

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.
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.
Tijdsspanne: 0-6 month

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
0-6 month

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ordu University

Onderzoekers

  • Studie directeur: Nülüfer ERBİL, Prof. Dr., Ordu university

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

4 mei 2026

Primaire voltooiing (Geschat)

4 augustus 2026

Studie voltooiing (Geschat)

4 november 2026

Studieregistratiedata

Eerst ingediend

28 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2026

Eerst geplaatst (Werkelijk)

13 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

6 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • OrduU-SBF-NKS-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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