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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-55
SponsorOrdu University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women who agree to participate in the study,

Have at least a primary school education,

Understand, read, and write Turkish,

Have no communication barriers,

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • value clarification

    Other intervention

    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 group

    Other intervention

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

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Intervention group: Value clarification groupActive comparator 1 intervention
Group B: Control group: No intervention will be applied.Active comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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