Protocol summary

Summary
In this study, 40 women referred to Psychiatric clinics of Tabriz University of Medical Sciences with psychiatrist with Obsessive compulsive disorder, diagnosed by interviewing and completing SADS, Yale-Brown and Beck anxiety questionnaires, were enrolled in this study after signing the written informed consent from. Then, the patients were randomly assigned into control or intervention group. Participants received the usual prescribed drugs by their physician. The intervention group received yoga instruction (Hata yoga method) by a trained yoga instructor twice a week for 10 sixty-minute sessions for 6 weeks. The control group was recommended to watch the favorite movies on TV at the same time. Finally, Yale-Brown and Beck anxiety questionnaires were filled and the results were compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138901192181N2
Registration date: 2010-11-06, 1389/08/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-11-06, 1389/08/15
Registrant information
Name
Fatemeh Ranjbar Kouchaksaraei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 6923
Email address
ranjbarf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2009-06-21, 1388/03/31
Expected recruitment end date
2010-06-21, 1389/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of yoga effects on anxiety in women with obsessive compulsive disorder
Public title
Effect of yoga on women with obsessive compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Outpatient women over 18 years received typical treatment for obsessive compulsive disorder, willing to do yoga, signing informed consent Exclusion Criteria: any other medical diseases, substance or drug dependence, low intelligence, cognitive problems, personality disorder, prominent anxiety or depression with obsessive compulsive disorder and psychosis
Age
From 18 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research, Tabriz University of Medical Sciences
Street address
Floor 3, number 2 central building,Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Postal code
Approval date
2009-07-05, 1388/04/14
Ethics committee reference number
5/4/1408

Health conditions studied

1

Description of health condition studied
Obsessive compulsive disorder
ICD-10 code
F42.2
ICD-10 code description
neurotic stress-related and somatoform disorder

Primary outcomes

1

Description
The severity of obsessive compulsive disorder
Timepoint
before and after the intervention
Method of measurement
the yale-brown rating scale

Secondary outcomes

1

Description
The severity of Anxiety
Timepoint
before and after the intervention
Method of measurement
the Beck anxiety rating scale

Intervention groups

1

Description
Intervention group: Preliminary Yoga instructions, Hata Yoga (standard method), twice weekly, for 10 sessions of 60 minutes, for 6 weeks by trained instructor
Category
Other

2

Description
Control group: Recommended to watch their favorite movies on TV at the same time as the intervention group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Psychiatry clinics of Tabriz University of Medical Sciences
Full name of responsible person
Dr Fatemeh Ranjbar Kouchaksaraie
Street address
Special clinics of Tabriz University of Medical Siences, Bozorgmehr psychiatric clinic
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Fatemeh Ranjbar Kouchaksaraie
Street address
Floor 3, number 2 central building, Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Grant name
Grant code / Reference number
9/2/88
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Fatemeh Ranjbar Kouchaksaraie
Position
Psychiatrist, Associate professor
Other areas of specialty/work
Street address
Razi hospital, Elgoli road
City
Tabriz
Postal code
Phone
+98 41 1380 4486
Fax
Email
ranjbarf@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Fatemeh Ranjbar Kouchaksaraie
Position
Psychiatrist-Associate professor
Other areas of specialty/work
Street address
Razi hospital-El goli road
City
Tabriz
Postal code
Phone
+98 41 1380 4486
Fax
Email
ranjbarf@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mehdi Broomand
Position
Resident
Other areas of specialty/work
Street address
Razi hosoital, Elgoli road
City
Tabriz
Postal code
Phone
+98 41 1381 6993
Fax
Email
Drbroomand@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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