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CTRI Number  CTRI/2024/03/064463 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 03/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Mindfulness ]  
Study Design  Single Arm Study 
Public Title of Study   The Effect of Mindful Sport Performance Enhancement (MSPE) Intervention on High School Football Players 
Scientific Title of Study   The Effect of Mindful Sport Performance Enhancement (MSPE) Intervention on Burnout, Flow, and Performance of High-School Football Players 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Darlene Amanda Maria Mascarenhas 
Designation  PhD Scholar 
Affiliation  PhD Scholar, Kasturba Medical College, Mangalore 
Address  Department of Psychiatry Kasturba Medical College, Manipal Academy of Higher Education, Mangaluru 575001, Dakshina Kannada District, Karnataka, India.
KASTURBA MEDICAL COLLEGE Light House Hill Road Mangalore – 575 001 91-0824-2422271, EXT 5504 est.kmcmlr@manipal.edu
Dakshina Kannada
KARNATAKA
575001
India 
Phone  9923150846  
Fax    
Email  darlene.kmcmlr2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. Keshava Pai K 
Designation  Professor and H.O.D, Department of Psychiatry 
Affiliation  Manipal Academy of Higher Education, KMC Hosptials 
Address  Department of Psychiatry Kasturba Medical College, Manipal Academy of Higher Education, Mangaluru 575001, Dakshina Kannada District, Karnataka, India.
KASTURBA MEDICAL COLLEGE Light House Hill Road Mangalore – 575 001 91-0824-2422271, EXT 5504 est.kmcmlr@manipal.edu
Dakshina Kannada
KARNATAKA
575001
India 
Phone  9448105227  
Fax    
Email  pai.keshava@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Darlene Amanda Maria Mascarenhas 
Designation  PhD Scholar 
Affiliation  PhD Scholar, Kasturba Medical College, Mangalore 
Address  Department of Psychiatry Kasturba Medical College, Manipal Academy of Higher Education, Mangaluru 575001, Dakshina Kannada District, Karnataka, India.
KASTURBA MEDICAL COLLEGE Light House Hill Road Mangalore – 575 001 91-0824-2422271, EXT 5504 est.kmcmlr@manipal.edu
Dakshina Kannada
KARNATAKA
575001
India 
Phone  9923150846  
Fax    
Email  darlene.kmcmlr2023@learner.manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education (MAHE), Madhav Nagar, Manipal, Udupi Karnataka, 576104 India 
 
Primary Sponsor  
Name  Darlene Amanda Maria Mascarenhas 
Address  Department of Psychiatry Kasturba Medical College, Mangalore Dakshin Kannada 575001 
Type of Sponsor  Other [Self-Funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Keshava Pai K  Kasturba Medical College Hospital, Attavar Mangalore  Department of Psychiatry, Room No. 14, KMC HospitaL Attavar, Nandigudda Rd. Attavar, Mangalore, 575002, India
Dakshina Kannada
KARNATAKA 		 9448105227

pai.keshava@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Burnout, Flow and Performance 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mindful Sport Performance Enhancement (MSPE)  Mindfulness techniques (body scan meditation, walking meditation, sitting meditation, mindful yoga, sports meditation) and practicing mindfulness to improve performance and psychological flow states of athletes. 
Comparator Agent  Mindful Sport Performance Enhancement (MSPE)  Post-test data will be analyzed after completion of MSPE Program. Statistical T-test will be performed to identify Pre-test and Post-test difference/change 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  High School Football Players from schools that follow standard guidelines of ICSE, CBSE, or State Board of Education.

High school football players from schools that participate in inter-school competitions.
High school football players from schools receive training/ coaching.

High school football players involved in the sport for one year or more. 
 
ExclusionCriteria 
Details  High School Football Players undergoing any mental illness.

High School Football Players undergoing personal psychotherapy or pharmacological treatment for any mental illness.

High School Football players involved in the sport for less than one year. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Athlete Burnout  6 sessions, 1 month, 3 month follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
Improved psychological flow states and performance enhancement  6 sessions, 1 month, 3 month follow-up 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [darlene.kmcmlr2023@learner.manipal.edu].

  6. For how long will this data be available start date provided 08-08-2027 and end date provided 08-08-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study aims to evaluate the effectiveness of Mindful Sport Performance Enhancement Intervention(MSPE) (C R Glass et al.,) on Burnout, Flow and Performance of High School Football Players. Considering the issue of burnout that young athletes might be exposed to as a result of extensive sports training, the study will evaluate if MSPE will be an effective tool to counteract symptoms of Athlete Burnout and promote Psychological Flow States and Performance.  
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