Comparison of the effect of acupuncture and exercise training on the level of anxiety in patients with generalized anxiety disorder (GAD)
Design
A randomized controlled clinical trial with parallel groups, no blinding, randomized
Settings and conduct
120 female with GAD that referred by a psychiatrist according to DSM5 diagnostic criteria and Sung Anxiety Questionnaire (S.A.S). Patients were selected from referrals to Mostsfavian and Tooba specialty clinics 1 and 2 and Zareei hospital and Sari private offices.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. People who have been diagnosed with GAD according to DSM5 criteria by a psychiatrist.
2. The degree of anxiety of patients less than severe
3. Female gender
4. Informed consent to participate in the study
5. Literacy of reading and writing
6. Age 18-60 years
7. Patients should not use opiates, stimulants, and other psychiatric drugs since 6 weeks prior to study.
8. No history of chronic physical illness
Exclusion criteria
۱. Dissatisfaction with continuing to participate in the study
2. Past history of suicide
3. Hematoma complication as a result of acupuncture and exacerbation of musculoskeletal diseases with exercise therapy.
4. Pregnant women
5. Absence for more than 3 sessions
Comparison of the effect of acupuncture and exercise training on anxiety level of generalized anxiety disorder (GAD) patients
Public title
The effect of acupuncture and exercise on GAD patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People who have been diagnosed with GَAD according to the DSM 5 criteria by a psychiatrist.
Patients' anxiety levels are less than severe.
Patients have informed consent to participate in the study.
Patients with literacy (at least third grade of elementary school to read and write Persian correctly).
Patients did not have any opiate, stimulants, and other psychiatric medications from the 6 weeks before beginning of the study until after completing the last Anxiety Questionnaire.
Patients do not have a history of chronic physical illness.
Patients have female gender.
Patients age 60-18 years.
Exclusion criteria:
Patients have a history of suicide.
Pregnant women
Hematoma as a result of acupuncture and exacerbation of musculoskeletal diseases with exercise therapy
Patients were not happy to continue the study
Absent more than 3 sessions
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Three cards containing the treatment groups are in the container and the patient selects one. Then the card enters the container and the next patient selects another card.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moalem Street. Moalem Square. Vice chancellor for research, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2019-10-01, 1398/07/09
Ethics committee reference number
IR.MAZUMS.REC.1398.901
Health conditions studied
1
Description of health condition studied
Generalized Anxiety Disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
S.A.S questionnaire anxiety score
Timepoint
0,6,10 week
Method of measurement
S.A.S questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pharmacotherapy and acupuncture. Acupuncture, two sessions per week with needle number 25 * 0.25 in areas Li4, Du20, PC6, SP6, HT7 and LU7 according to the theory of managers for 20 minutes by sport medicine resident
Category
Treatment - Other
2
Description
Intervention group: Drug therapy and exercise therapy. Exercise training including Shrug, Crunch, Hip abduction, Heel raise, 3 sets daily with 15 repetitions and 20 minutes daily aerobic exercise (100 steps per minute)
Category
Treatment - Other
3
Description
Control group: Pharmacotherapy.Pharmacotherapy under the supervision of plan psychiatrist
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mostafavian Clinic
Full name of responsible person
Dr. Gholamreza Partovi
Street address
Razi 3
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 6552
Email
ghpartovi@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Moalem
City
Sari
Province
Mazandaran
Postal code
4471848178
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Partovi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Razi 3
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 6552
Email
ghpartovi@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Gholamreza Partovi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Amir Mazandarani Ave., Emam Khomeyni Hospital
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 6552
Fax
+98 11 3336 3754
Email
ghpartovi@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Partovi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Razi 3
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 6552
Email
ghpartovi@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Results of statistical analysis and its analysis
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Health researchers
Under which criteria data/document could be used
View data
From where data/document is obtainable
corresponding author
What processes are involved for a request to access data/document