- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07589777
Trauma-Informed Yoga Intervention in Young Women
Trauma-Informed Yoga Intervention: A Randomized Controlled Trial on Psychological Trauma, Emotion Regulation, and Interoceptive Awareness in Young Adult Women
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study will be conducted with young adult women aged 18-25 residing in a selected province. Based on a G*Power analysis, the minimum required sample size was determined to be 46 participants (intervention: n = 23; control: n = 23). Participants will be randomly assigned to the intervention and control groups using a computer-generated simple randomization method (https://www.random.org/integers/
) to ensure unbiased allocation. The intervention group will be implemented in three separate groups, each consisting of 8-10 participants, and will receive the "Trauma-Informed Yoga Intervention Program," which includes eight sessions. Each session will last approximately 45 minutes, and two sessions will be conducted per week for each group. The program will consist of group-based yoga sessions structured in accordance with trauma-informed principles. Pretest and posttest measurements will be used to assess psychological trauma symptoms, difficulties in emotion regulation, and levels of interoceptive awareness among young women.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Duygu Özer, Asst. Prof
- Numéro de téléphone: +905061291978
- E-mail: duyguozer2016@hotmail.com
Lieux d'étude
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Bartın
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Bartın, Bartın, Turquie (Türkiye), 74100
- Bartın University
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Contact:
- Duygu Özer
- E-mail: duyguozer@bartin.edu.tr
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Being a woman aged 18-25 years
- Providing voluntary written informed consent after being informed about the study
- Scoring within the highest 25th percentile on the Transmitted Psychological Trauma Scale based on the pre-screening assessment, indicating high levels of trauma-related symptoms
- Having no physical limitations that would prevent participation in weekly sessions and being medically eligible to engage in yoga practices
- Agreeing to comply with the study protocol, including attendance at intervention sessions and completion of all assessments
Exclusion Criteria:
- Inability to provide reliable responses due to the presence of active psychotic disorder, bipolar disorder, or severe cognitive impairment
- Being in an acute psychological crisis
- Initiation of intensive psychotherapy targeting trauma symptoms (e.g., trauma-focused therapy) within the past 3 months or participation in a similar structured psychosocial intervention during the study period
- Presence of serious musculoskeletal, cardiovascular, or neurological conditions or injuries that would prevent participation in yoga, or medical restriction of physical activity by a physician
- Having an established regular practice of yoga or meditation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Experimental
Participants in the intervention group received a trauma-informed, group-based yoga program consisting of eight sessions delivered twice weekly.
Each session lasted approximately 45 minutes and was conducted in accordance with trauma-informed principles.
|
Intervention program was applied to the intervention group in eight sessions online.
Each session will last an average of 45 minutes.
There will be two sessions for one group per week.
The intervention comprised eight sessions, including establishing a sense of safety and body awareness, listening to the body, integrating emotions and movement, safely engaging with past memories, fostering forgiveness and letting go, strengthening boundaries and personal empowerment, cultivating self-compassion and reconnection, and promoting integration and future orientation.
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Aucune intervention: Control
Participants in the control group received no structured intervention during the study period and only routine conditions were maintained.
Data were collected at the same time points as in the intervention group.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Transmitted Psychological Trauma Scale
Délai: Baseline, immediately post-intervention, and 1 month post-intervention
|
The scale consists of 19 items and three subscales: family functioning (3 items), past family trauma (5 items), and emotion and behavior regulation (11 items).
Two items (items 3 and 5) in the scale are reverse scored.
Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Total scores range from 19 to 95, with higher scores indicating a greater likelihood of transmitted psychological trauma.
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Baseline, immediately post-intervention, and 1 month post-intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Difficulties in Emotion Regulation Scale - Short Form (DERS-16)
Délai: Baseline, immediately post-intervention, and 1 month post-intervention
|
The scale consists of 16 items and five subscales: clarity, goals, impulse, strategies, and non-acceptance.
The scale items are rated on a 5-point Likert scale, ranging from 1 (Almost never) to 5 (Almost always), with total scores ranging from 16 to 80. Higher scores indicate greater difficulty in emotion regulation.
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Baseline, immediately post-intervention, and 1 month post-intervention
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Multidimensional Assessment of Interoceptive Awareness - Version 2
Délai: Baseline, immediately post-intervention, and 1 month post-intervention
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The scale consists of 34 items rated on a 6-point Likert scale ranging from 0 (never) to 5 (always).
The number of items varies across the subscales: Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting.
Total scores on the scale range from 0 to 170.
The scale does not have an established cut-off point.
Higher scores indicate greater levels of interoceptive awareness.
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Baseline, immediately post-intervention, and 1 month post-intervention
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BARU-SBF-DO-3
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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