Mind-Body Intervention in Earthquake Survivors: 6 mo RCT
29. April 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
26
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Emine Sağlamoğlu, Master
- Telefonnummer: +905388749386
- E-Mail: eminesaglamoglu@gmail.com
Studieren Sie die Kontaktsicherung
- Name: gamze ekici, professor
- Telefonnummer: +903123052560
- E-Mail: fztgamze@yahoo.com
Studienorte
-
-
-
Ankara, Türkei (türkiye)
- Hacettepe University
-
Kontakt:
- Emine Sağlamoğlu
- Telefonnummer: +905388749386
- E-Mail: eminesaglamoglu@gmail.com
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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
|
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
|
|
Aktiver Komparator: 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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Canadian Occupational Performance Measure (COPM) - Performance and Satisfaction Scores
Zeitfenster: 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.
|
Baseline, at the end of the 4-week intervention, and at the 6-month follow-up.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Hospital Anxiety and Depression Scale - Anxiety Sub-scale (HADS-A)
Zeitfenster: Baseline, Week 4, and Month 6.
|
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.
|
Baseline, Week 4, and Month 6.
|
|
Hospital Anxiety and Depression Scale - Depression Sub-scale (HADS-D)
Zeitfenster: Baseline, Week 4, and Month 6.
|
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.
|
Baseline, Week 4, and Month 6.
|
|
Nottingham Health Profile (NHP) Domain Scores
Zeitfenster: Baseline, Week 4, and Month 6.
|
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.
|
Baseline, Week 4, and Month 6.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
20. April 2026
Primärer Abschluss (Geschätzt)
30. Mai 2026
Studienabschluss (Geschätzt)
30. November 2026
Studienanmeldedaten
Zuerst eingereicht
21. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. April 2026
Zuerst gepostet (Tatsächlich)
4. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. April 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2026-231
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
UNENTSCHIEDEN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .