- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02661906
A Pilot Study on Effect of SKY on Psychosocial Parameters of Type 2 Diabetic Patients After a 6 Days
Effect of SKY on Anxiety, Depression and Quality of Life of Type 2 Diabetic Patients After a 6 Days Intervention
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Diabetes is a psychologically and behaviorally demanding disease; therefore psychosocial factors are relevant to nearly all aspects of its management. Research findings have demonstrated that depression is more common in patients with diabetes than in the general population, at least 15 % of patients have clinical depression.Yoga is a mind-body alternative therapy which can be used to prevent and treat type 2 diabetes mellitus and related complications.
Sudarshan kriya Yoga is a unique yogic breathing practices which involves several types of cyclical breathing patterns, ranging from slow and calming to rapid and stimulating. It is recommended for relaxation, stress management, control of psycho physiological states and to improve organ function. In this pilot study Investigator recruited 24 type 2 diabetic patient and those who consent were provided with 6 days yoga course for a duration of 3 hours and trained to practice SKY at home for 12 week. At baseline and after 6 days of SKY, questionnaire on anxiety, depression and quality of life were provided to them. Biochemical parameters were measured at baseline and after 12 weeks of yoga. Two follow up yoga session were provided to the participants. Primary outcome were pre to post intervention change in the mental health and quality of life.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Kuwait, Koweit, 1180
- Dasman Diabetes Institute
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion criteria
- Patients showing stress as per the stress indicators.
- Patients of both gender of age 30 to 65 years on oral anti diabetic agents
- Patient is able to perform yoga postures and breathing exercise.
- Patient is able to consent for the study.
- Patient should be able to understand English as that is the medium used.
Exclusion criteria
- Bipolar disorder
- Antidepressant drugs
- Type 1 diabetes
- Pregnancy
- Any acute coronary symptoms in past 6 months
- Artificial pace-maker
- Previous (SKY) or any type of spiritual meditation practiced within 6 months
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: SKY Pre
Sudarshan Kriya Yoga is provided to all the enrolled participants.
The baseline characteristics of patient is compared with that of their characteristics after yoga intervention.
All the participants were provided with yoga training for 6 days and then asked to perform the SKY at home daily till 12 week.
The questionnaire on anxiety, depression and quality of life were administered at the baseline and at the end of 6 days of yoga.
Biochemical parameters such as HbA1c, lipid profile, fasting glucose and post meal glucose were measured at baseline and after 12 week of intervention.
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Sudarshan Kriya Yoga is a rhythmic breathing exercise with slow and fast breath at a particular pace.It is recommended for stress management as yoga is a mind body control tool.
SKY is having effect on multiple organ thus causing the positive effect.
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Comparateur actif: SKY post
The enrolled participants were provided with SKY intervention and their pre and post data were recorded.
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Sudarshan Kriya Yoga is a rhythmic breathing exercise with slow and fast breath at a particular pace.It is recommended for stress management as yoga is a mind body control tool.
SKY is having effect on multiple organ thus causing the positive effect.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Improvement in quality of life
Délai: at 12 week
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change in score of Questionnaires on anxiety at 12 week of yoga intervention
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at 12 week
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Improvement in HbA1c
Délai: at12 week of intervention
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Change in HbA1c value at 12 week of yoga intervention
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at12 week of intervention
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Improvement in BMI
Délai: at 12 week of intervention
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Change in BMI at 12 week of yoga intervention
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at 12 week of intervention
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Improvement in lipid profile
Délai: at 12 week of intervention
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Change in lipid levels at 12 week of yoga intervention
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at 12 week of intervention
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Rashmi Shiju, Mpharm, Dasman Diabetes Institute
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RA 2014-028
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