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Starting soon Not applicable

Mind-Body Intervention in Earthquake Survivors: 6 mo RCT

NCT07563556 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-04-20
Last updated
2026-05-04

Condition(s) studied

Earthquake Victim

Investigational drug(s) / intervention(s)

combined mind-body interventionRoutine Care and Follow-up Phone Calls

combined mind-body intervention: The intervention consists of 8 individual sessions (30-40 mins, twice weekly) combining Jacobson's Progressive Muscle Relaxation (PMR) and Guided Imagery. Sessions begin with 5 minutes of diaphragmatic breathing. PMR involves 15 minutes of tensing and relaxing specific muscle groups (limbs, face, trunk) to reduce physical tension. This is followed by 15 minutes of Guided Imagery, visualizing sensory-rich "safe places" (e.g., childhood gardens) to promote emotional regulation. Participants perform 15-minute daily home practice. Sessions take place in a quiet, dimly lit environment with relaxing music. For physiological standardization, participants avoid caffeine, nicotine, and food one hour before. This occupational therapy protocol aims to enhance participation in daily activities (self-care, work, leisure) and reduce stress levels

Routine Care and Follow-up Phone Calls: Participants receive their standard routine care. Additionally, they will be contacted by phone twice a week for 4 weeks by the primary investigator to inquire about their general health and well-being. These calls are limited to status inquiries to ensure that any observed changes in the study are due to the intervention itself rather than the attention provided by the researcher.

Study summary

The purpose of this study is to investigate whether a 4-week program called "Combined Mind-Body Intervention" can help survivors of the February 6, 2023, earthquakes manage stress and improve their ability to participate in daily activities. The study specifically aims to answer the following question: Does a program combining guided imagery and progressive muscle relaxation lead to significant, long-term improvements in occupational performance (self-care, work, and leisure), reduced stress levels, and better overall quality of life for earthquake survivors when compared to a control group?

The study will involve:

Target Population: Adults aged 18 to 65 who directly experienced the 2023 earthquakes and currently reside in the affected region .Intervention: Participants in the intervention group will attend eight individual sessions (twice a week) focusing on deep breathing, step-by-step muscle relaxation, and guided visualization of peaceful environments.

Evaluation: Changes in stress, mood, and daily activity performance will be measured at the beginning of the study, at the end of the 4-week program, and during a 6-month follow-up period to determine the lasting effects of the intervention.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Being between 18 and 65 years old. * Having directly experienced the February 6, 2023 earthquake. * Currently residing in the earthquake zone. * Possessing sufficient cognitive and language skills to participate in assessments and the intervention. Exclusion Criteria: * Having an additional psychiatric or neurological disease diagnosis. * Having received non-pharmacological interventions (such as psychotherapy, CBT, art therapy, or meditation) before or during the study. * Currently using psychiatric medications. * Having a history of other physical (e.g., violence) or psychological trauma. * Being pregnant or currently breastfeeding. * Having a current substance addiction. * Demonstrating suicidal tendencies.

Primary outcome measure(s)

  • Canadian Occupational Performance Measure (COPM) - Performance and Satisfaction Scores — Baseline, at the end of the 4-week intervention, and at the 6-month follow-up.
    The COPM is a semi-structured interview used to identify and prioritize issues in occupational performance. Participants rate their perceived performance and satisfaction for their top five identified problem areas in daily activities (self-care, productivity, and leisure). Both scales use a 10-point Likert scale ranging from 1 ("not able to do it" or "not satisfied") to 10 ("able to do it extremely well" or "extremely satisfied") . Higher scores indicate better occupational performance and higher satisfaction.

Trial sites (1)

FacilityCityRegionStatus
Hacettepe University Ankara Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07563556 on ClinicalTrials.gov ↗ ← All trials in Turkey