Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000175471
Ethics application status
Approved
Date submitted
16/03/2007
Date registered
20/03/2007
Date last updated
20/03/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Wellness through yogic breathing exercises
Scientific title
Improvement of wellness in participants who suffer from depression, anxiety and stress through a comprehensive Yogic Breathing Program – A controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 1690 0
Anxiety 1691 0
Optimism 1692 0
Stress 1693 0
Condition category
Condition code
Mental Health 1784 1784 0 0
Depression
Mental Health 1785 1785 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Yogic breathing program: includes simple yoga postures + three different types of yogic breathing exercises. A single session including these takes 30-40 min which is practiced once a day for 6 weeks.
Intervention code [1] 1652 0
Lifestyle
Comparator / control treatment
Control: sitting with eyes closed for 15 min per day in a quiet setting for 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 2495 0
Depression and anxiety: Hospital Anxiety and Depression scale (HAD) score > 10
Timepoint [1] 2495 0
At baseline and at 5 weeks after finishing the instruction.
Primary outcome [2] 2496 0
Stress: >3 in the Stress and Energy (SE) scale
Timepoint [2] 2496 0
At baseline and at 5 weeks after finishing the instruction.
Secondary outcome [1] 4304 0
Intervention experienced as a positive event that induced beneficial effects.
Timepoint [1] 4304 0
At 6 weeks after the commencement of the intervention.

Eligibility
Key inclusion criteria
Healthy subjects without any chronic disease with documented interest in yoga.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any chronic disease, pregnancy, high blood pressure, psychiatric disorders.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Data analyst was blinded
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
103
Accrual to date
Final
Recruitment outside Australia
Country [1] 489 0
Sweden
State/province [1] 489 0

Funding & Sponsors
Funding source category [1] 1936 0
University
Name [1] 1936 0
Karlstad University
Country [1] 1936 0
Sweden
Primary sponsor type
University
Name
Karlstad University
Address
Country
Sweden
Secondary sponsor category [1] 1747 0
None
Name [1] 1747 0
None
Address [1] 1747 0
Country [1] 1747 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3607 0
Karlstad University Ethical Board
Ethics committee address [1] 3607 0
Ethics committee country [1] 3607 0
Sweden
Date submitted for ethics approval [1] 3607 0
Approval date [1] 3607 0
Ethics approval number [1] 3607 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27586 0
Address 27586 0
Country 27586 0
Phone 27586 0
Fax 27586 0
Email 27586 0
Contact person for public queries
Name 10841 0
Anette Kjellgren
Address 10841 0
Department of Psychology, Karlstad University
SE-65188 Karlstad
Country 10841 0
Sweden
Phone 10841 0
+46 547002173
Fax 10841 0
+46 54839165
Email 10841 0
Anette.Kjellgren@kau.se
Contact person for scientific queries
Name 1769 0
Anette Kjellgren
Address 1769 0
Department of Psychology, Karlstad University
SE-65188 Karlstad
Country 1769 0
Sweden
Phone 1769 0
+46 547002173
Fax 1769 0
+46 54839165
Email 1769 0
Anette.Kjellgren@kau.se

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.