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

Diabetes Mellitus, Non-Insulin-Dependent Clinical Trial

Official title:

Effect of SKY on Anxiety, Depression and Quality of Life of Type 2 Diabetic Patients After a 6 Days Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02661906
• Other study ID #: RA 2014-028
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: February 2018

Study information

• Verified date: August 2016
• Source: Dasman Diabetes Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion criteria

1. Patients showing stress as per the stress indicators.

2. Patients of both gender of age 30 to 65 years on oral anti diabetic agents

3. Patient is able to perform yoga postures and breathing exercise.

4. Patient is able to consent for the study.

5. Patient should be able to understand English as that is the medium used.

Exclusion criteria

1. Bipolar disorder

2. Antidepressant drugs

3. Type 1 diabetes

4. Pregnancy

5. Any acute coronary symptoms in past 6 months

6. Artificial pace-maker

7. Previous (SKY) or any type of spiritual meditation practiced within 6 months

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2

Intervention

Other:
• SKY
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.

Locations

Country	Name	City	State
Kuwait	Dasman Diabetes Institute	Kuwait

Sponsors (1)

Lead Sponsor	Collaborator
Dasman Diabetes Institute

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in quality of life	change in score of Questionnaires on anxiety at 12 week of yoga intervention	at 12 week
Secondary	Improvement in HbA1c	Change in HbA1c value at 12 week of yoga intervention	at12 week of intervention
Secondary	Improvement in BMI	Change in BMI at 12 week of yoga intervention	at 12 week of intervention
Secondary	Improvement in lipid profile	Change in lipid levels at 12 week of yoga intervention	at 12 week of intervention