Clinical trial NCT02661906: A Pilot Study on Effect of SKY on Psychosocial Parameters of Type 2 Diabetic Patients After a 6 Days
Official title: Effect of SKY on Anxiety, Depression and Quality of Life of Type 2 Diabetic Patients After a 6 Days Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Lead sponsor: Dasman Diabetes Institute
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in quality of life
timeFrame: at 12 week
Secondary outcomes:
measure: Improvement in HbA1c
timeFrame: at12 week of intervention
measure: Improvement in BMI
timeFrame: at 12 week of intervention
measure: Improvement in lipid profile
timeFrame: at 12 week of intervention
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Dasman Diabetes Institute
Study officials:
affiliation: Dasman Diabetes Institute
name: Rashmi Shiju, Mpharm
role: PRINCIPAL_INVESTIGATOR
References: