Protocol summary

Summary
In this study, 40 women referred to Psychiatric clinics of Tabriz University of Medical Sciences and were interviewed and asked to complete SADS and Spielberger questionnaires. They were diagnosed with generalized anxiety disorder and after considering the inclusion and exclusion criteria enrolled in this study after filling the written informed consent from. Then, the patients were randomly assigned into control or intervention group. Participants received the usual prescribed drug by their physician. The two groups were matched regarding age, severity of anxiety, and drug dosage. The intervention group was given yoga instruction (Hata yoga method) by a trained yoga instructor twice a week for 10 sixty minutes sessions for 6 weeks. The control group was recommended to watch the favorite movie on TV on the similar occasion to the intervention group. Finally, Spielberger questionnaires were filled and the results were compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138804242181N1
Registration date: 2009-06-06, 1388/03/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-06-06, 1388/03/16
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
Research Vice Chancellory of Tabriz University of Medical Sciences
Expected recruitment start date
2009-06-06, 1388/03/16
Expected recruitment end date
2010-05-27, 1389/03/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of yoga on women with generalized anxiety disorder
Public title
Effect of yoga on women with anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women over the age 18, taking usual drugs for generalized anxiety disorder, outpatient setting, cooperation for yoga, signing the written informed consent Exclusion criteria: comorbidity with physical illness, substance dependence or taking special drug, low intelligence, patients with cognitive disorder, personality disorder, mixed anxiety and depression disorder with prominent anxiety disorder, 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
Research Vice Chancellory of Tabriz University of Medical Sciences
Street address
Floor 2, number 2 central building, Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Postal code
Approval date
2008-12-24, 1387/10/04
Ethics committee reference number
8370/4/5

Health conditions studied

1

Description of health condition studied
Generalized Anxiety Disorder
ICD-10 code
F41.1
ICD-10 code description
anxiety disorder

Primary outcomes

1

Description
Severity of anxiety
Timepoint
6 weeks
Method of measurement
Complete the Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: hata yoga preliminary period twice a week for 10 sixty minute sessions (6 weeks)
Category
Treatment - Drugs

2

Description
Control: watch the favorite movie on tv on the similar occasion
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Psychiatric clinic of Tabriz University of Medical Sciences
Full name of responsible person
Psychiatrist
Street address
Bozorgmehr Clinic, Southern Artesh Street, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Siences
Full name of responsible person
Research Vice Chancellor
Street address
Floor 3, number 2 central building,Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Grant name
Grant code / Reference number
2008/12/23
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Siences
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 Scences
Full name of responsible person
Fatemeh Ranjbar Kouchaksaraei
Position
Associate Professor
Other areas of specialty/work
Street address
Razi Hospital, Elgoli Road, Tabriz
City
Tabriz
Postal code
5167846184
Phone
+98 41 1380 4486
Fax
+98 41 1380 3351
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
Fatemeh Ranjbar Kouchaksaraei
Position
Associate Professor
Other areas of specialty/work
Street address
Razi Hospital, Tabriz
City
Tabriz
Postal code
5167846184
Phone
+98 41 1380 4486
Fax
+98 41 1380 3351
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
Leila Hemmati
Position
Resident
Other areas of specialty/work
Street address
Razi hospital, Tabriz
City
Tabriz
Postal code
5167846184
Phone
+98 41 1380 4486
Fax
+98 41 1380 3351
Email
dr.hematy@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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