Protocol summary

Study aim
Comparison of the Effectiveness of Neurofeedback and Mindfulness Training in Improving Executive Functions among Athletic Students
Design
In the present study, there were 20 subjects in each group where a total of 60 qualified people with the desired age range were selected and 20 participants were randomly assigned to each of the groups, including neurofeedback group, mindfulness group, and control group.
Settings and conduct
The research was conducted at the Faculty of Physical Education in Kharazmi University. Then, all participants in the experimental groups and control groups will take the pre-test and all three groups will be assessed by executive function tests. Subsequently, participants in the neurofeedback group will undergo the number of sixteen 45-minute sessions of neurofeedback training (Beta / Theta / Teta / SMR protocol) during 8 weeks; and participants in the Mindfulness Group only will receive eight 45-minute sessions of mindfulness exercises during eight weeks. However, the control group will not receive any training.
Participants/Inclusion and exclusion criteria
Inclusion criteria ؛ Physical and Mental Health (Not Taking Psychiatric Drugs) ؛ They should be Physical Education students at Bachelor's program (at least second-semester students and at most eighth-semester students). ؛ Be a boy student exclusion criteria ؛ Participants who have undergone surgery in the cranium area or have had a problem with their nervous system. (People with certain diseases in the head area)
Intervention groups
؛ the neurofeedback group receive neurofeedback training twice a week during 8 weeks. ؛ the mindfulness group receive mindfulness training once a week during 8 weeks. ؛ The control group receives no training
Main outcome variables
Attention; response inhibition; working memory; planning; cognitive flexibility

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171006036596N2
Registration date: 2018-05-11, 1397/02/21
Registration timing: retrospective

Last update: 2018-05-11, 1397/02/21
Update count: 0
Registration date
2018-05-11, 1397/02/21
Registrant information
Name
zahra kermani mamazandi
Name of organization / entity
university of semnan
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4100
Email address
z.kermani@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
STUDENT
Expected recruitment start date
2017-11-19, 1396/08/28
Expected recruitment end date
2017-12-19, 1396/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Neurofeedback and Mindfulness Training in Improving Executive Functions (Attention, Inhibition Response, Working Memory, Planning, and Cognitive Flexibility) among Athletic Students
Public title
Comparison of the Effectiveness of Neurofeedback and Mindfulness in Improving Executive Functions among Students
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Physical and Mental Health (Not Taking Psychiatric Drugs) The age range of participants is between 18 and 25 years old They should be Physical Education students at Bachelor's program (at least second-semester students and at most eighth-semester students). None of the participants should be familiar with neurofeedback training and mindfulness training. Having at least the necessary verbal skills and willingness to attend training sessions Participants should be involved at least in one sport field No use of any psychotherapy and counseling services at the time of conducting the research or before it Be a boy student
Exclusion criteria:
Inappropriate physical status (having a medical record), taking psychiatric drugs Not being fully prepared and satisfied preparation to attend the training sessions Participants who have undergone surgery in the cranium area or have had a problem with their nervous system. (People with certain diseases in the head area)
Age
From 18 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Regarding the entry criteria, simple random method will be used for sampling. The researcher will go to physical education students, and the students will be registered. According to the entry criteria, the eligible individuals will stay and we prepare a list of them. Then, 60 people will be selected randomly and will be assigned to three 20-member groups and, eventually, we allocate the assignments. The randomization unit is of an individual type. Using the random number table, we take out and select the numbers. Due to the limited statistical population, simple random sampling is used. The assignment of numbers to participants is possible only by the researcher, and the other individuals are not aware of these numbers.
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 Semnan University of Medical Sciences
Street address
Semnan, Basij Boulevard, Central Administration of Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2017-11-17, 1396/08/26
Ethics committee reference number
IR.SEMUMS.REC.1396,115

Health conditions studied

1

Description of health condition studied
Normal people
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Planning
Timepoint
Before intervention - after intervention and one month following the end of the last intervention sessions
Method of measurement
Tower of London software

2

Description
Attention and Response Inhibition
Timepoint
Before intervention - after intervention and one month following the end of the last intervention sessions
Method of measurement
Complex Stroop software

3

Description
Working memory
Timepoint
Before intervention - after intervention and one month following the end of the last intervention sessions
Method of measurement
N-back working memory software

4

Description
Cognitive Flexibility
Timepoint
Before intervention - after intervention and one month following the end of the last intervention sessions
Method of measurement
Wisconsin Software

Secondary outcomes

empty

Intervention groups

1

Description
Neurofeedback. Participants in the neurofeedback group will undergo sixteen 45-minute sessions of neurofeedback training (beta / theta and theta / SMR protocols) during 8 weeks. Procamp 2 neurofeedback device and BioGraph Infiniti Software will be used in this stage. This device has been made by Thought Technology Company of Canada.
Category
Rehabilitation

2

Description
Mindfulness. Participants in the Mindfulness group will receive eight 45-minute sessions of mindfulness training during eight weeks.
Category
Rehabilitation

3

Description
Control group. The control group will not receive any training.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Physical Education, Kharazmi University
Full name of responsible person
Zahra Kermani Mamazandi
Street address
kharazmi University, Hesarak, Karaj
City
Karaj
Province
Alborz
Postal code
3138744746
Phone
+98 26 3457 4724
Email
z.kermani@semnan.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Semnan
Full name of responsible person
Zahra Kermani Mamazandi
Street address
Central Organization of Semnan University, Campus 1, Across from Sokan Park, Semnan
City
Semnan
Province
Semnan
Postal code
3513119111
Phone
+98 23 3365 4100
Email
z.kermani@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Semnan
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
The University of Semnan
Full name of responsible person
Zahra Kermani Mamazandi
Position
Phd of Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Psychology, Semnan University, Mahdishahr, Semnan
City
Mahdishahr
Province
Semnan
Postal code
3564111156
Phone
+98 23 3362 3300
Fax
Email
z.kermani@semnan.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of semnan
Full name of responsible person
Zahra Kermani Mamazandi
Position
Phd of Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Psychology & Educational Sciences Mahdishahr , Semnan University , Darband, Mehdishahr, Semnan, Iran.
City
Mahdishahr
Province
Semnan
Postal code
3564111156
Phone
+98 23336233300
Fax
Email
z.kermani@semnan.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
The University of Semnan
Full name of responsible person
Zahra Kermani Mamazandi
Position
Phd of Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Psychology, Semnan University, Mahdishahr, Semnan
City
Mahdishahr
Province
Semnan
Postal code
3564111156
Phone
+98 23 3362 3300
Fax
Email
z.kermani@semnan.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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