Condition category
Mental and Behavioural Disorders
Date applied
26/04/2006
Date assigned
07/06/2006
Last edited
07/06/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andreas Michalsen

ORCID ID

Contact details

Am Deimelsberg 34a
Essen
45276
Germany
+49 (0)201 8054002
andreas.michalsen@uni-essen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

03-06 K

Study information

Scientific title

Acronym

Study hypothesis

Three months of Iyengar Yoga training leads to reduced perceived stress, according to the perceived stress scale (PSS)

Ethics approval

Approved by the Ethics Committee of the University Hospital of Essen on 08/03/2006, reference number: 06-2968

Study design

Randomised controlled trial with waiting list

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Perceived higher stress according to PSS scale

Intervention

Group A: 3 months Iyengar yoga 2 x 90 minutes per week
Group B: 3 months Iyengar yoga 1 x 90 minutes per week
Group C: waiting list

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Differences between the groups of perceived stress reduction (yoga versus waiting list) after three months of intervention

Secondary outcome measures

Between group differences (yoga versus waiting list and intensified versus moderate yoga) in:
1. Anxiety
2. Depression scores (state trait anxiety inventory [STAI], hospital anxiety and depression scale [HADS])
3. Mood and well-being (Profile of Mood States [POMS])
4. Quality of life (short-form questionnaire-36 [SF-36], heart rate variability and blood pressure during mental and physical stress)
5. Complaint lists
6. Cortisol profiles in saliva samples

Overall trial start date

04/05/2006

Overall trial end date

10/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women 20 to 55 years of age
2. Higher stress according to PSS
3. Having 3 of 8 stress symptoms:
a. Insomnia
b. Back pain
c. Neck pain
d. Fatigue
e. Cold hands
f. Reduced day-time alertness
g. Eating disorder
h. Tension-type headache

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

72

Participant exclusion criteria

1. Severe comorbidity
2. Gravidity
3. Psychiatric disease
4. Severe orthopedic malfunction

Recruitment start date

04/05/2006

Recruitment end date

10/05/2006

Locations

Countries of recruitment

Germany

Trial participating centre

Am Deimelsberg 34a
Essen
45276
Germany

Sponsor information

Organisation

Karl and Veronica Carstens Foundation (Germany)

Sponsor details

Am Deimelsberg 36
Essen
45276
Germany
+49 (0)201 563050
info@carstens-stiftung.de

Sponsor type

Charity

Website

http://www.carstens-stiftung.de

Funders

Funder type

Charity

Funder name

Karl and Veronica Carstens Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes