Medical Yoga for Patients With Stress-related Symptoms and Diagnoses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elisabeth Westerdahl, University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT01604707
First received: May 15, 2012
Last updated: June 4, 2014
Last verified: June 2014

May 15, 2012
June 4, 2014
March 2011
May 2012   (final data collection date for primary outcome measure)
Perceived stress scale [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]
The Perceived Stress Scale is a 10-item self report questionnaire that measures persons' evaluation of the stressfulness of the situations in the past month of their lives. Cohen, S., & Williamson, G. (1988). PSS-10 scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. Scores can range from 0 to 40, with higher scores indicating greater stress.
Perceived Stress Scale [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01604707 on ClinicalTrials.gov Archive Site
Shirom-Melamed Burnout Questionnaire [ Time Frame: 12 week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Medical Yoga for Patients With Stress-related Symptoms and Diagnoses
Medical Yoga for Patients With Stress-related Symptoms and Diagnoses in Primary Health Care - a Randomized Controlled Trial

Background An increasing number of patients are suffering from stress-related symptoms and diseases. No scientific studies have examined the effects of Medical yoga on stress-related symptoms in patients in primary care. The purpose of this study was to evaluate Medical yoga treatment in patients with stress-related symptoms and diagnosis in primary health care.

Methods A randomized, controlled study was performed at a primary health care centre in Sweden from March to June 2011. Patients were randomly allocated to a control group receiving standard care, or a yoga group treated with Medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age 53±12 years, seeking care for stress-related symptoms at the primary health care centre were included and followed up after the 12-week study period. General stress level (measured using Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity (Insomnia Severity Index (ISI)), pain (visual analogue scale (VAS)) and overall health status (Euro Quality of Life-VAS (EQ-VAS)) were measured before and after 12 weeks.

Main outcome:

The Perceived Stress Scale is a 10-item self report questionnaire that measures persons' evaluation of the stressfulness of the situations in the past month of their lives. The citation for the 10-item scale is Cohen, S., & Williamson, G. (1988). Perceived stress in a probability sample of the United States. In S. Spacapan & S. Oskamp (Eds.). The Perceived Stress Scale is the only empirically established index of general stress appraisal. "The PSS measures the degree to which situations in one's life are appraised as stressful" (Cohen, et al., 1983; p. 385).

PSS-10 scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. Scores can range from 0 to 40, with higher scores indicating greater stress.

The PSS is not a diagnostic instrument, so there are no cut-offs. There are only comparisons between people in a given sample. There are some normative data on the PSS based on a 1983 Harris Poll of a representative U.S. sample. These data may be helpful in providing comparisons, but they are over 20 years old. See: Cohen, S., & Williamson, G. (1988).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Stress
  • Anxiety
  • Depression
Other: Medical Yoga
Patients were randomly allocated to a control group receiving standard care, or a yoga group treated with Medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care.
Other Name: Medical Yoga group
  • No Intervention: Control group
    Standard care
  • Experimental: Medical Yoga
    Group training with medical yoga in primary health care.
    Intervention: Other: Medical Yoga

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The patients had sought treatment at the primary health centre during the previous 6 months.
  • The stress-related symptoms included fatigue, insomnia, anxiety, depression, hypertension, and musculoskeletal discomfort in the neck and shoulders.

Exclusion Criteria:

  • Inability to understand instructions, interpretation needs or physical or mental inability to carry out the Medical yoga exercises, such as mental retardation or dementia, and severe physical or mental illness.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01604707
MEDYOG 1
No
Elisabeth Westerdahl, University Hospital Orebro
University Hospital Orebro
Not Provided
Principal Investigator: Elisabeth Westerdahl, PhD University Hospital Orebro
University Hospital Orebro
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP