- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07376395
Effects of Jin Shin Jyutsu-Based Hand Application on Quality of Life and Psychosocial Status in Perimenopausal Women
The Effect of Jin Shin Jyutsu-Based Hand Application Guided by the Transactional Model of Stress and Coping on Quality of Life and Psychosocial Status in Perimenopausal Women
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eslem Altıntaş, M.Sc.
- Phone Number: +90 541 610 54 12
- Email: eslem.altintas@acibadem.edu.tr
Study Locations
-
-
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Istanbul, Turkey (Türkiye)
- Istanbul Provincial Directorate of Health - Family Health Centers
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 40-54 years
- Being in the perimenopausal period according to the STRAW+10 criteria
- Being literate
Exclusion Criteria:
- Use of hormone replacement therapy
- Regular use of complementary or alternative therapy
- History of diagnosed psychiatric disorders
- Inability to comply with the intervention protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Jin Shin Jyutsu-Based Hand Application
Participants assigned to this arm will receive a Jin Shin Jyutsu®-based hand application intervention guided by the Transactional Model of Stress and Coping.
The intervention includes an initial individual training session (approximately 30-40 minutes) providing education on stress, coping, and the principles of Jin Shin Jyutsu®, followed by a structured self-application protocol.
Participants will practice the hand application daily for 14 consecutive days, for at least 15 minutes per day, and will be supported with reminder messages to enhance adherence.
This intervention is designed as a supportive self-care approach rather than a medical treatment.
|
Participants assigned to the experimental arm will receive a Jin Shin Jyutsu®-based hand application program guided by the Transactional Model of Stress and Coping. During the initial session, participants will receive a structured face-to-face training lasting approximately 30-40 minutes, including verbal instruction, visual materials, and a practical demonstration of the hand application techniques. Participants will be instructed to practice the Jin Shin Jyutsu® hand application daily for at least 15 minutes over a 14-day period. The intervention is designed as a self-care-based supportive approach and does not involve medical treatment, physical manipulation, or pharmacological therapy. To support adherence, participants will receive written instructions, a daily self-monitoring log, and brief reminder messages via WhatsApp® during the intervention period. No additional therapeutic techniques or relaxation interventions will be provided. |
|
Active Comparator: Control Group
Participants assigned to this arm will receive standard informational counseling related to general health during perimenopause.
This includes a brief verbal education session (approximately 10-15 minutes) covering perimenopause-related changes and general lifestyle recommendations, such as sleep hygiene, balanced nutrition, physical activity, and stress awareness.
No Jin Shin Jyutsu® techniques or relaxation interventions will be provided during the study period.
Outcome assessments will be conducted at the same time points as the experimental group.
|
Participants assigned to the control group will receive standard verbal health education related to general health during perimenopause.
The content includes information on common perimenopausal changes and general lifestyle recommendations.
No Jin Shin Jyutsu® techniques, relaxation exercises, or structured coping interventions are included.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Descriptive Information Form
Time Frame: Day 1 (Baseline, Pre-Intervention)
|
This is a 24-question form designed by researchers to determine participants' sociodemographic characteristics, women's health status, general health knowledge, lifestyle, and support levels.
|
Day 1 (Baseline, Pre-Intervention)
|
|
Coping Strategies
Time Frame: Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 14 (Post-intervention for intervention groups, after routine assessment for active comparator).
|
The Stress Coping Methods Scale (SBÇYÖ) is a self-report questionnaire assessing active and cognitive coping strategies used by adults when facing stressful situations.
The scale consists of 21 items rated on a 5-point Likert scale (1-5) and includes five subdomains: logical analysis, positive reappraisal, problem solving, seeking professional support, and seeking environmental support.
Total and subscale scores increase as the corresponding coping strategy is used more frequently.
Higher scores indicate greater use of the specified coping strategy.
|
Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 14 (Post-intervention for intervention groups, after routine assessment for active comparator).
|
|
Menopause-Specific Quality of Life
Time Frame: Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 14 (Post-intervention for intervention groups, after routine assessment for active comparator).
|
The Menopause-Specific Quality of Life Questionnaire - II (MENQOL / MÖYKÖ-II) is a validated self-report instrument developed to assess the presence and severity of menopause-related symptoms and their impact on quality of life across vasomotor, psychosocial, physical, and sexual domains. The scale consists of 29 items. For each item, participants indicate whether the symptom is present; if present, the level of discomfort is rated. Item scores are converted to a 1-8 scoring system. The total score ranges from 29 to 232, with higher scores indicating worse quality of life and greater negative impact of menopausal symptoms. |
Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 14 (Post-intervention for intervention groups, after routine assessment for active comparator).
|
|
Distress Thermometer
Time Frame: Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 14 (Post-intervention for intervention groups, after routine assessment for active comparator).
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The Distress Thermometer is a single-item visual analog scale designed to rapidly assess overall psychological distress. Participants rate their distress level on a scale ranging from 0 (no distress) to 10 (extreme distress). Higher scores indicate higher levels of psychological distress. In this study, the problem list accompanying the Distress Thermometer is not used. |
Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 14 (Post-intervention for intervention groups, after routine assessment for active comparator).
|
|
Depression, Anxiety, and Stress
Time Frame: Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 14 (Post-intervention for intervention groups, after routine assessment for active comparator).
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The Depression Anxiety Stress Scales-21 (DASS-21) is a self-report questionnaire assessing depression, anxiety, and stress symptoms over the past week. It consists of 21 items, with three subscales of seven items each. Items are rated on a 4-point Likert scale (0-3). Subscale scores range from 0 to 42 after standard score conversion. Higher scores indicate greater levels of depression, anxiety, and stress, reflecting worse psychological outcomes. |
Day 1 (Baseline, before intervention for intervention groups, before routine assessment for control group) and Day 14 (Post-intervention for intervention groups, after routine assessment for active comparator).
|
|
Daily Practice Schedule for JSJ®-Based Hand Application
Time Frame: The intervention group will complete this chart for 14 days.
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This chart, developed by the researchers, is designed for participants to regularly record their daily practices for 14 days.
The chart includes the day, total time, whether the five-finger grip was completed, and notes.
This chart will be used to monitor the level of adherence to the intervention and the frequency of problem-focused coping actions.
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The intervention group will complete this chart for 14 days.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression, Anxiety, and Stress
Time Frame: Baseline and 2 weeks post-intervention
|
Depression, anxiety, and stress levels will be evaluated using the Depression Anxiety Stress Scales-21 (DASS-21).
Total score and subscale scores for depression, anxiety, and stress will be analyzed.
Higher scores indicate greater psychological distress.
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Baseline and 2 weeks post-intervention
|
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Psychological Distress
Time Frame: Baseline and 2 weeks post-intervention
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Psychological distress will be assessed using the Distress Thermometer, a single-item self-report measure rated on a numerical scale from 0 to 10. Higher scores represent greater perceived distress.
|
Baseline and 2 weeks post-intervention
|
|
Coping Strategies
Time Frame: Baseline and 2 weeks post-intervention
|
Coping strategies will be assessed using the Coping Strategies Scale (Stress Coping Methods Scale).
Total score and subscale scores reflecting different coping approaches will be analyzed in accordance with the Transactional Model of Stress and Coping.
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Baseline and 2 weeks post-intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nevin Şahin, Prof. Dr., Istanbul University - Cerrahpasa
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-20/740
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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