Mind-Body Intervention in Earthquake Survivors: 6 mo RCT
29 de abril de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
26
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Emine Sağlamoğlu, Master
- Número de teléfono: +905388749386
- Correo electrónico: eminesaglamoglu@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: gamze ekici, professor
- Número de teléfono: +903123052560
- Correo electrónico: fztgamze@yahoo.com
Ubicaciones de estudio
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Ankara, Turquía (Türkiye)
- Hacettepe University
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Contacto:
- Emine Sağlamoğlu
- Número de teléfono: +905388749386
- Correo electrónico: eminesaglamoglu@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Canadian Occupational Performance Measure (COPM) - Performance and Satisfaction Scores
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Hospital Anxiety and Depression Scale - Anxiety Sub-scale (HADS-A)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
20 de abril de 2026
Finalización primaria (Estimado)
30 de mayo de 2026
Finalización del estudio (Estimado)
30 de noviembre de 2026
Fechas de registro del estudio
Enviado por primera vez
21 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2026
Publicado por primera vez (Actual)
4 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2026-231
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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