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Completed

NCT Number: NCT07164261

Progressive Muscle Relaxation Training in Post-traumatic Stress Disorder in Disasters

This randomized controlled trial aims to investigate the efficacy of Progressive Muscle Relaxation Training (PMRT) in individuals who developed Post-Traumatic Stress Disorder (PTSD) following the February 6 Kahramanmaraş earthquake.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bitlis Eren Universty

Bitlis, Bitlis /merkez, 13000, Turkey (Türkiye)

About this study

Post-traumatic stress disorder (PTSD) is an often devastating psychiatric condition that can occur in people who experience or witness a traumatic event.The estimated lifetime prevalence of PTSD is reported to be 6.8%.While trauma-focused psychotherapy is generally the first-line treatment in PTSD management, pharmacological treatments (selective serotonin reuptake inhibitors) are recommended in second-line treatment.Additionally, various physiotherapy and rehabilitation approaches such as aerobic, respiratory, relaxation, stretching, balance and strengthening exercises can also be used.Progressive muscle relaxation training increases parasympathetic nervous system activity. This is said to reduce anxiety and stress levels and improve sleep quality, resulting in physical and mental relaxation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals affected by the February 6 Kahramanmaraş earthquake.
  • Those diagnosed with Post-Traumatic Stress Disorder (PTSD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria or with a score of 47 or above on the Post-Traumatic Stress Disorder Checklist (PCL-5).
  • Aged 18-65 will be included.

Exclusion criteria

  • Individuals affected by disaster types other than the February 6 Kahramanmaraş earthquake (such as war, flood, landslide, etc.)"
  • Individuals with uncontrolled comorbidities accompanying PTSD (such as diabetes or hypertension)
  • serious psychological disorders (such as dementia, psychosis/manic episodes)
  • musculoskeletal conditions that would interfere with exercise training
  • received PMRT training within the last year
  • pregnant
  • have substance abuse
  • have communication difficulties, and are unable to use technology for telerehabilitation will not be included in the study

Treatment and study plan

progressive muscle relaxation training

Other

Progressive muscle relaxation training will be performed twice a week, each session lasting 20-30 minutes, for a total of 12 sessions over 6 weeks.

Primary outcomes

  1. PTSD Checklist (PCL-5) questionnaire

    Time frame: Change from baseline at 6 weeks

    This is a 20-question questionnaire, valid and reliable in Turkish, that assesses PTSD symptoms as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Questions are scored from 0 to 4, and the total score ranges from 0 to 80. A score of 47 or higher indicates the presence of PTSD.

  2. Depression Anxiety and Stress Scale-21 (DASS-21)

    Time frame: Change from baseline at 6 weeks

    It assesses an individual's condition over the past week. It is a 21-question survey consisting of three subscales: depression, anxiety, and stress. A high score on the scale indicates the presence and severity of depression, anxiety, and stress.

Secondary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Change from baseline at 6 weeks

    It is a 19-item index, valid and reliable in Turkish, that assesses individuals' sleep quality and disturbances over the past month. The index's 18 scored questions consist of seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleeping pill use, and daytime dysfunction. Each component is scored on a 0-3 scale, with a total score ranging from 0 to 21. A total PSQI score greater than 5 indicates inadequate sleep quality, while scores of 6-10 indicate poor sleep, and scores of 11 or higher indicate long-term sleep disturbance.

  2. Fatigue Severity Scale (FSS)

    Time frame: Change from baseline at 6 weeks

    It is a nine-item scale, valid and reliable in Turkish, that assesses individuals' fatigue levels. Individuals score each item on a scale of 1 to 7 (1 = completely disagree, 7 = completely agree). The total scale score ranges from 0 to 63, with scores of 36 and above indicating severe fatigue.

  3. Short Form-36 (SF-36) questionnaire

    Time frame: Change from baseline at 6 weeks

    It is a valid and reliable questionnaire in Turkish that assesses individuals' quality of life. It consists of 36 questions. The total score ranges from 0 to 100, with higher scores indicating a better quality of life.

Sponsors and collaborators

Lead sponsor

Bitlis Eren University

Other

Registry information

Official study title

Efficacy of Progressive Muscle Relaxation Training in Individuals With Post-Traumatic Stress Disorder Following the February 6 Kahramanmaraş Earthquake: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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