| CTRI Number |
CTRI/2024/02/062557 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Exercise ] |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of coordinated physical activities in enhancing the attention and concentration among school aged children in Pondicherry |
|
Scientific Title of Study
|
Effect of coordinated physical activities in enhancing the attention and concentration in school aged children |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jenifer E |
| Designation |
M. Sc Nursing - 2 year |
| Affiliation |
JIPMER |
| Address |
Psychiatric Nursing
college of Nursing
JIPMER
Viluppuram
TAMIL NADU
605111
India |
| Phone |
7639690913 |
| Fax |
|
| Email |
ejenifer69@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padmavathi N |
| Designation |
Assistant professor |
| Affiliation |
JIPMER |
| Address |
Assistant professor
College of Nursing
JIPMER
puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9487984637 |
| Fax |
|
| Email |
padmavathi2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Padmavathi N |
| Designation |
Assistant professor |
| Affiliation |
JIPMER |
| Address |
Assistant professor
College of Nursing
JIPMER
puducherry
PONDICHERRY
605006
India |
| Phone |
9487984637 |
| Fax |
|
| Email |
padmavathi2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund Jawaharlal institute of postgraduate medical education and research |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Jawaharlal institute of postgraduate medical education and research
Puducheery -605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Padmavathi N |
Pondicherry |
VIGNESHWARA HIGHER SECONDARY SHOOL SEDERAPET, PUDUCHERRY - 605111
Pondicherry
PONDICHERRY |
9487984637
ejenifer69@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for Nursing Courses |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
children of age 9 - 11 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
exercise |
coordinated physical activity will be give to the intervention group after 20 mins of regular class for 4 mins and their attention and concentration will be assessed after 20 sessions and compared with the control group |
| Comparator Agent |
No intervention |
pre test and post test will be done using d2 attention test |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
9-11 years |
|
| ExclusionCriteria |
| Details |
Children who are
Orthopedics disability
Cardiac disability
Hearing impaired
Exacerbation asthma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The attention and concentration will increase among the school aged children |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the effectiveness between attention and concentration with selected demographic variables |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
21/02/2024 |
| 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="0"
Months="0"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
yet to publish |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a non randomized control trail. In which we have two groups one for the intervention which will receive 20 day’s of coordinated physical activity by a video assistance after sitting in a class for 20 mins. The exercise will be for 4 mins .The control group will not receive the intervention. In both the group pre test and post test will be conducted with the d2 attention test . In control group the pre test and post test will be done with a interval of 20 days . The attention and concentration will be compared in both the group and effectiveness of coordinated physical activity is assessed |