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Completed

NCT Number: NCT02661906

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

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dasman Diabetes Institute

Kuwait City, 1180, Kuwait

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SKY

Other

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 outcomes

  1. Improvement in quality of life

    Time frame: at 12 week

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

Secondary outcomes

  1. Improvement in HbA1c

    Time frame: at12 week of intervention

    Change in HbA1c value at 12 week of yoga intervention

  2. Improvement in BMI

    Time frame: at 12 week of intervention

    Change in BMI at 12 week of yoga intervention

  3. Improvement in lipid profile

    Time frame: at 12 week of intervention

    Change in lipid levels at 12 week of yoga intervention

Sponsors and collaborators

Lead sponsor

Dasman Diabetes Institute

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 25, 2016
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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