NCT07376395

Brief Summary

This study aims to evaluate 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. Participants will receive a structured hand application intervention over a defined period. Outcomes related to quality of life and psychosocial well-being will be assessed before and after the intervention.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
15mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Feb 2026Aug 2027

First Submitted

Initial submission to the registry

January 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

January 22, 2026

Last Update Submit

January 30, 2026

Conditions

Keywords

PerimenopauseQuality of LifeDepressionAnxietyStress

Outcome Measures

Primary Outcomes (6)

  • Descriptive Information Form

    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

    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

    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

    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

    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

    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.

    The intervention group will complete this chart for 14 days.

Study Arms (2)

Jin Shin Jyutsu-Based Hand Application

EXPERIMENTAL

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.

Behavioral: Jin Shin Jyutsu®-Based Hand Application

Control Group

ACTIVE COMPARATOR

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.

Behavioral: General Health Education

Interventions

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.

Control Group

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.

Jin Shin Jyutsu-Based Hand Application

Eligibility Criteria

Age40 Years - 54 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 40-54 years
  • Being in the perimenopausal period according to the STRAW+10 criteria
  • Being literate

You may not qualify if:

  • Use of hormone replacement therapy
  • Regular use of complementary or alternative therapy
  • History of diagnosed psychiatric disorders
  • Inability to comply with the intervention protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Provincial Directorate of Health - Family Health Centers

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Nevin Şahin, Prof. Dr.

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.Sc.

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 29, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations