YogaNCT01168648
Yoga for Stress Management in Health Care Personnel
A study testing Yoga as stress management and Rest without using any relaxation technique in people with Yoga and Stress, Psychological, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate if yoga can be an effective stress management technique for health care personnel. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Yoga, Stress, Psychological, Stress, Physiological
- What is being tested?
- Yoga as stress management and Rest without using any relaxation technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2003to May 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 18-30
- healthy
- work in the health care sector
Who cannot join
- medication, including contraceptives and all medications or topical skin preparations with cortisone in any form (exception: hormone replacement therapy for hypothyroidism were included if their hormone levels were within the normal range)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Center for Family and Community Medicine, KI
Huddinge, Stockholm County, 141 83
About this study
Official title: Yoga for Stress Management in Health Care Personnel and Its Relation to the Hypothalamus-pituitary-adrenal(HPA)Axis
The purpose of this study is to investigate if yoga can be an effective stress management technique for health care personnel.
Read the detailed description
Stress, both job related and personal, is an increasing problem in the health care sector. Yoga is said to have a good stress-reducing effect.
The participants will provide blood, urine, and saliva samples. They will take part in two different stress tests. They will also fill in various qualitative questionnaires, including the Swedish questionnaire on health related quality of life (SWEDQUAL), Antonovsky's sense of coherence scale (KASAM), and the Job stress survey (JSS), both before the study starts and after 3 months of participation.
- Conditions
- Yoga, Stress, Psychological, Stress, Physiological
- Being tested
- Yoga as stress management, Rest without using any relaxation technique
- Keywords
- Yoga, Stress, Stress management, Hypothalamus-pituitary-adrenal axis
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga as stress managementBehavioural
Also called Asanas(physical postures or movements), Pranayama (breathing exercises), Meditation
Yoga specially designed to reduce stress is practiced for approximately 30 minutes at least three times a week for three months, once in a group session led by a trained yoga instructor and twice or more at home. The yoga techniques used are physical postures or movements, meditation and breathing exercises. Every time they do the techniques, participants fill in a form detailing how they feel before and after and providing information on the experience of doing the exercises.
Rest without using any relaxation techniqueOther
The participants rest at home at least 30 minutes, at least three times a week for three months and without using any relaxation technique
| Study group | Role | What they receive |
|---|---|---|
| Yoga as stress management | Experimental | The intervention consists of following a program of yoga at least three times a week for three months. The yoga program has been designed to reduce stress. Receives: Behavioral: Yoga as stress management |
| Control group | Active comparator | The group rests without using any specific program for relaxation at least three times a week for three months. Receives: Other: Rest without using any relaxation technique |
| Yoga as stress management fewer tests | Other | Eight persons participated in the same intervention as the experimental arm but did not undergo the full range of tests because they did not meet all the inclusion criteria for the study, most commonly because of medication use or body mass index. Receives: Behavioral: Yoga as stress management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced cortisol secretion
Measured: Three months
Secondary outcomes (1)
Reduced stress measured by qualitative questionnaires (SWEQUAL, JSS, KASAM)
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startAug 2003
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for YogaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Ekhaga Foundation Stockholm Sweden, Region Stockholm
- Investigators
- Astrid M Grensman, MD, Principal investigator, KI, Center for Family and Community MedicineBikash D Acharya, M sc in Psy, Principal investigator, KI, Center for Family and Community Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168648
- Sponsor's protocol ID
- Ekhagastiftelsen 2001-5
- Status last verified
- Jul 2010
- First submitted
- 22 Jul 2010
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga for Stress Management in Health Care Personnel and Its Relation to the Hypothalamus-pituitary-adrenal(HPA)Axis
- ClinicalTrials.gov ID
- NCT01168648
- Acronym / sponsor ID
- Ekhagastiftelsen 2001-5
- Conditions
- Yoga, Stress, Psychological, Stress, Physiological
- Keywords
- Yoga, Stress, Stress management, Hypothalamus-pituitary-adrenal axis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Ekhaga Foundation Stockholm Sweden, Region Stockholm
- Study start
- Aug 2003
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 23 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate if yoga can be an effective stress management technique for health care personnel.
Detailed description
Stress, both job related and personal, is an increasing problem in the health care sector. Yoga is said to have a good stress-reducing effect.
The participants will provide blood, urine, and saliva samples. They will take part in two different stress tests. They will also fill in various qualitative questionnaires, including the Swedish questionnaire on health related quality of life (SWEDQUAL), Antonovsky's sense of coherence scale (KASAM), and the Job stress survey (JSS), both before the study starts and after 3 months of participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga as stress management | Experimental | Behavioral: Yoga as stress managementThe intervention consists of following a program of yoga at least three times a week for three months. The yoga program has been designed to reduce stress. |
| Control group | Active comparator | Other: Rest without using any relaxation techniqueThe group rests without using any specific program for relaxation at least three times a week for three months. |
| Yoga as stress management fewer tests | Other | Behavioral: Yoga as stress managementEight persons participated in the same intervention as the experimental arm but did not undergo the full range of tests because they did not meet all the inclusion criteria for the study, most commonly because of medication use or body mass index. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI 18-30
- healthy
- work in the health care sector
Key exclusion criteria (1 listed)
- medication, including contraceptives and all medications or topical skin preparations with cortisone in any form (exception: hormone replacement therapy for hypothyroidism were included if their hormone levels were within the normal range)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga as stress managementAlso: Asanas(physical postures or movements), Pranayama (breathing exercises), MeditationYoga specially designed to reduce stress is practiced for approximately 30 minutes at least three times a week for three months, once in a group session led by a trained yoga instructor and twice or more at home. The yoga techniques used are physical postures or movements, meditation and breathing exercises. Every time they do the techniques, participants fill in a form detailing how they feel before and after and providing information on the experience of doing the exercises. | Behavioural | Yoga as stress management, Yoga as stress management fewer tests |
| Rest without using any relaxation techniqueThe participants rest at home at least 30 minutes, at least three times a week for three months and without using any relaxation technique | Other | Control group |
Primary outcome
Reduced cortisol secretion
Time frame: Three months
1 secondary outcome
Reduced stress measured by qualitative questionnaires (SWEQUAL, JSS, KASAM)
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astrid M Grensman, MD principal investigator
KI, Center for Family and Community Medicine
Bikash D Acharya, M sc in Psy principal investigator
KI, Center for Family and Community Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga as stress management and Rest without using any relaxation technique in people with Yoga and Stress, Psychological, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced cortisol secretion (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2010.