| CTRI Number |
CTRI/2024/06/068408 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
To Assess The Impact Of education regarding inculcating good Sleep practices on Sleep quality And academic performance Of Children Studying In 6th And 7th Standard In Selected Schools Of Chandigarh UT 2023-25. |
|
Scientific Title of Study
|
A Randomized Cluster Control Trial To Assess The Impact Of ‘Sleep Hygiene Package’ On Sleep Hygiene And Scholastic Performance Of Children Studying In 6th And 7th Standard In Selected Schools Of Chandigarh UT 2023-25. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepshiekha |
| Designation |
M.Sc. Nursing student |
| Affiliation |
NINE, PGIMER |
| Address |
Room no. 201, National Institue of Nursing Education, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9468168325 |
| Fax |
|
| Email |
deepshiekha22gupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepshiekha |
| Designation |
M.Sc. Nursing student |
| Affiliation |
NINE, PGIMER |
| Address |
National Institute of Nursing Institue, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9468168325 |
| Fax |
|
| Email |
deepshiekha22gupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepshiekha |
| Designation |
M.Sc. Nursing student |
| Affiliation |
NINE, PGIMER |
| Address |
National Institue Of Nursing Education, PGIMER
National Institute of Nursing Institue, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9468168325 |
| Fax |
|
| Email |
deepshiekha22gupta@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
deepshiekha |
| Address |
#626, Phase 4, Mohali |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| Deepshiekha |
Govt schools of Candigarh UT |
GMHS, Sec25
GSSS, Sec45
GMSSS, Sec47
GGMSSS, Sec23A
Chandigarh
CHANDIGARH |
9468168325
deepshiekha22gupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural), PGIMER |
Approved |
| Institutional Ethics Committee (Intramural), PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
students of 6th and 7th standard |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sleep Hygiene Package |
some lifestyle modification that improves sleep |
| Comparator Agent |
Sleep hygiene package to intervention group only |
some lifestyle modification including physical exercise, setting a schedule of sleeping, dietary modification that improves sleep |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
School Children of 6th and 7th standard
Willingness of parents to participate
|
|
| ExclusionCriteria |
| Details |
• School children on leave during study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep hygiene score and scholastic performance |
at baseline and endline at 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| scholastic performance |
at baseline & endline at 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
16/07/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A randomized cluster control trial to assess the impact of ‘sleep hygiene package’ on sleep hygiene and scholastic performance of children studying in 6th and 7th standard in selected schools of Chandigarh UT 2023-25. |