Mind-Body Intervention in Earthquake Survivors: 6 mo RCT
29 avril 2026 mis à jour par: Emine Sağlamoğlu, Hacettepe University
Examining the Effect of Combined Mind-body Intervention in Earthquake Survivors: A 6 Months Follow-up Randomized Controlled Trial
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
26
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Emine Sağlamoğlu, Master
- Numéro de téléphone: +905388749386
- E-mail: eminesaglamoglu@gmail.com
Sauvegarde des contacts de l'étude
- Nom: gamze ekici, professor
- Numéro de téléphone: +903123052560
- E-mail: fztgamze@yahoo.com
Lieux d'étude
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Ankara, Turquie (Türkiye)
- Hacettepe University
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Contact:
- Emine Sağlamoğlu
- Numéro de téléphone: +905388749386
- E-mail: eminesaglamoglu@gmail.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Combined Mind-Body Intervention
his group receives 8 individual sessions, conducted twice weekly for 30 to 40 minutes.Each session consists of Jacobson's progressive muscle relaxation and guided imagery techniques.Participants are also instructed to perform daily home practice
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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
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Comparateur actif: Control Group (Routine Care & Monitoring)
Participants receive routine care along with supplemental support.They will be contacted by phone twice a week for 4 weeks by the investigator to monitor their general health status.The phone calls are limited to general status inquiries to minimize bias related to investigator attention.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Canadian Occupational Performance Measure (COPM) - Performance and Satisfaction Scores
Délai: Baseline, at the end of the 4-week intervention, and at the 6-month follow-up.
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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.
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Baseline, at the end of the 4-week intervention, and at the 6-month follow-up.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Hospital Anxiety and Depression Scale - Anxiety Sub-scale (HADS-A)
Délai: Baseline, Week 4, and Month 6.
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This 7-item sub-scale specifically measures anxiety levels.
Scores range from 0 to 21.
Higher scores indicate greater anxiety; lower scores reflect clinical improvement.
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Baseline, Week 4, and Month 6.
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Hospital Anxiety and Depression Scale - Depression Sub-scale (HADS-D)
Délai: Baseline, Week 4, and Month 6.
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This 7-item sub-scale specifically measures depression levels.
Scores range from 0 to 21.
Higher scores indicate more severe depression; lower scores reflect clinical improvement.
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Baseline, Week 4, and Month 6.
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Nottingham Health Profile (NHP) Domain Scores
Délai: Baseline, Week 4, and Month 6.
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Separate assessment of six domains: Physical Mobility (8 items), Pain (8 items), Sleep (5 items), Energy Level (3 items), Emotional Reactions (9 items), and Social Isolation (5 items).
Each domain is scored from 0 to 100.
Higher scores represent more severe problems in that specific area of health.
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Baseline, Week 4, and Month 6.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
20 avril 2026
Achèvement primaire (Estimé)
30 mai 2026
Achèvement de l'étude (Estimé)
30 novembre 2026
Dates d'inscription aux études
Première soumission
21 avril 2026
Première soumission répondant aux critères de contrôle qualité
29 avril 2026
Première publication (Réel)
4 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 avril 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2026-231
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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