Determination of the Effectiveness of Acupuncture Intervention on competitive anxiety level in football players
Design
A double blinded, crossed over, randomized by sealed envelope, controlled clinical trial with a sample size of 20 individual which will be conducted between May 2019 and June 2019.
Settings and conduct
The study will be conducted in Sports Medicine Research Center. Participants will complete the questionnaire before and after the intervention. Skin conductance and heart rate will be measured before and after the intervention. Intervention consists of acupuncture in anxiety related points for 30 minutes. Control group will receive acupuncture in none related points for anxiety. Participants, researcher, assessor of the outcome and data analyzers will also be blinded.
Participants/Inclusion and exclusion criteria
inclusion criteria: Being over 19 years old; Male gender; Having experience of playing football for at least one year; Practicing for at least 3 sessions per week.
Criteria of not being included: Having history of acupuncture in the past; Consuming drugs; Having any history of depressive disorder or anxiety disorder; Having symptoms of over-training.
Intervention groups
Intervention group consists of acupuncture in anxiety related points and control group consists of acupuncture in none related points to anxiety .
Main outcome variables
Competitive anxiety score; heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141115019948N3
Registration date:2019-03-08, 1397/12/17
Registration timing:prospective
Last update:2019-03-08, 1397/12/17
Update count:0
Registration date
2019-03-08, 1397/12/17
Registrant information
Name
Tohid Seif barghi
Name of organization / entity
Sports Medicine Research Center, Department of Sports and Exercise Medicine, Tehran University of Me
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 0227
Email address
tohid_seif@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of acupuncture intervention on levels of competitive anxiety among football players
Public title
Effect of acupuncture on levels of competitive anxiety among football players
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being over 19 years old
Male gender
Having experience of playing football for at least one year
Practicing for at least 3 sessions per week
Exclusion criteria:
Having history of acupuncture in past
Consuming drugs
Having any history of depressive disorder or anxiety disorder
Having symptoms of over-training
Age
From 19 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomisation method will be performed by using a sealed envelope with the individual unit.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be blinded about the type of intervention. Researcher and evaluator of the outcome and data analyzers will also be blinded.
Placebo
Used
Assignment
Crossover
Other design features
The design of the study is a cross over study and will be conducted in two consecutive phase with a week interval.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
No. 7, Bolvar Keshavarz Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
IR.TUMS.REC.1395.2871
Health conditions studied
1
Description of health condition studied
Competitive anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety NOS
Primary outcomes
1
Description
Score of competitive anxiety in CSAI-2 questionaire
Timepoint
Measurement of the score of competitive anxiety before intervention and one hour after intervention
Method of measurement
CSAI-2 Questionaire
Secondary outcomes
1
Description
Heart rate
Timepoint
Measurement of the heart rate before intervention and one hour after intervention
Method of measurement
Measurement of radial pulse
2
Description
Skin conductance rate
Timepoint
Measurement of the skin conductance rate before and one hour after intervention
Method of measurement
Via GSR_temp 2x-relaxation device
Intervention groups
1
Description
Intervention group includes of acupuncture in anxiety related points for 30 minutes.
Category
Other
2
Description
Control group: includes of acupuncture in none related points for anxiety for 30 minutes.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports Medicine Research Center
Full name of responsible person
Tohid Seif Barghi
Street address
No. 7, Jalal Al Ahmad Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2282
Fax
Email
tohid_seif@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad ALI Sahraian
Street address
No. 6, Keshavarz Ave
City
Tehran
Province
Tehran
Postal code
1439500578
Phone
+98 21 8163 3685
Email
tohid_seif@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Tohid Seif Barghi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No. 7, Ale-Ahmad Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21611900
Fax
Email
tohid_seif@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tohid Seif Barghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No. 7, Jalal al ahmad Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8863 0227
Fax
Email
tohid_seif@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tohid Seif Barghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No. 7, Jalal Al Ahmad Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 88630227
Fax
Email
tohid_seif@yahoo.com
Web page address
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All collected deidentified data will be shared.
When the data will become available and for how long
Starting 6 months after publication for 6 months.
To whom data/document is available
Data will be only available for people working in academic institutions.
Under which criteria data/document could be used
Using the study protocol is permitted
From where data/document is obtainable
Contact via the email address.
tohid_seif@yahoo.com
What processes are involved for a request to access data/document
Contact via the email address.
Request for the data.
The data will be send by 2 month.