A Pilot Study on Effect of SKY on Psychosocial Parameters of Type 2 Diabetic Patients After a 6 Days

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent
• Interventions: Other: SKY

• Registration Number: NCT02661906
• Lead Sponsor: Dasman Diabetes Institute

Brief Summary

The purpose of this study is to determine whether Sudarshan Kriya Yoga intervention has effect on the quality of life , anxiety and depression of Type 2 Diabetic Patients.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-25
• Status Verified: 2016-08
• Study Start: 2016-08
• Primary Completion: 2017-12
• Study Completion: 2018-02
• Last Update Submitted: 2019-02-10
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SKY Pre	SKY	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.
SKY post	SKY	The enrolled participants were provided with SKY intervention and their pre and post data were recorded.

Primary Outcome Measures

Name	Time	Method
Improvement in quality of life	at 12 week	change in score of Questionnaires on anxiety at 12 week of yoga intervention

Secondary Outcome Measures

Name	Time	Method
Improvement in HbA1c	at12 week of intervention	Change in HbA1c value at 12 week of yoga intervention
Improvement in BMI	at 12 week of intervention	Change in BMI at 12 week of yoga intervention
Improvement in lipid profile	at 12 week of intervention	Change in lipid levels at 12 week of yoga intervention

Trial Locations

Locations (1)

Dasman Diabetes Institute; 🇰🇼 Kuwait, Kuwait