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

Primary Purpose

Diabetes Mellitus, Non-Insulin-Dependent

Status
Completed
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
SKY
Sponsored by
Dasman Diabetes Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Non-Insulin-Dependent

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dasman Diabetes Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SKY Pre

SKY post

Arm Description

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.

The enrolled participants were provided with SKY intervention and their pre and post data were recorded.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improvement in HbA1c
Change in HbA1c value at 12 week of yoga intervention
Improvement in BMI
Change in BMI at 12 week of yoga intervention
Improvement in lipid profile
Change in lipid levels at 12 week of yoga intervention

Full Information

First Posted
October 8, 2015
Last Updated
February 10, 2019
Sponsor
Dasman Diabetes Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02661906
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dasman Diabetes Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Non-Insulin-Dependent

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SKY Pre
Arm Type
Experimental
Arm Description
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.
Arm Title
SKY post
Arm Type
Active Comparator
Arm Description
The enrolled participants were provided with SKY intervention and their pre and post data were recorded.
Intervention Type
Other
Intervention Name(s)
SKY
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in quality of life
Description
change in score of Questionnaires on anxiety at 12 week of yoga intervention
Time Frame
at 12 week
Secondary Outcome Measure Information:
Title
Improvement in HbA1c
Description
Change in HbA1c value at 12 week of yoga intervention
Time Frame
at12 week of intervention
Title
Improvement in BMI
Description
Change in BMI at 12 week of yoga intervention
Time Frame
at 12 week of intervention
Title
Improvement in lipid profile
Description
Change in lipid levels at 12 week of yoga intervention
Time Frame
at 12 week of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rashmi Shiju, Mpharm
Organizational Affiliation
Dasman Diabetes Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dasman Diabetes Institute
City
Kuwait
ZIP/Postal Code
1180
Country
Kuwait

12. IPD Sharing Statement

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

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