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CTRI Number  CTRI/2022/06/043556 [Registered on: 28/06/2022] Trial Registered Prospectively
Last Modified On: 29/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of school sleep hygiene awareness program on the mood and performance of adolescent students  
Scientific Title of Study   A Randomized control trial to assess the effect of school sleep hygiene awareness program on the mood and performance of adolescent students  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ruchi Singh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences Bhopal 
Address  Fourth Floor, Department of Physiology, AIIMS Bhopal, Saket Nagar
AIIMS Bhopal
Bhopal
MADHYA PRADESH
462020
India 
Phone  7773010095  
Fax    
Email  ruchi.physiology@aiimsbhopal.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ruchi Singh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences Bhopal 
Address  Fourth Floor, Department of Physiology, AIIMS Bhopal, Saket Nagar
AIIMS Bhopal

MADHYA PRADESH
462020
India 
Phone  7773010095  
Fax    
Email  ruchi.physiology@aiimsbhopal.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ruchi Singh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences Bhopal 
Address  Fourth Floor, Department of Physiology, AIIMS Bhopal, Saket Nagar
AIIMS Bhopal

MADHYA PRADESH
462020
India 
Phone  7773010095  
Fax    
Email  ruchi.physiology@aiimsbhopal.edu.in  
 
Source of Monetary or Material Support  
Indian Council of medical research 
 
Primary Sponsor  
Name  ICMR 
Address  Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
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 Ruchi Singh  AIIMS Bhopal  Department of Physiology, AIIMS Bhopal, Saket nagar
Bhopal
MADHYA PRADESH 
7773010095

ruchi.physiology@aiimsbhopal.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IHEC AIIMS Bhopal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Sleep deprivation in school students 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Food and exercise program   Students will be educated on the importance of healthy food and exercise, but would not be emphasized for following a sleep hygiene. There will be almost 3-4 educational sessions in 1st and 2nd week of interaction and then the students will be followed up through reminders on their parents mobile through sms, watsapp or through mobile application to be developed indigenously in this program, to receive feedback about their sleep/food/excercise routine through parents  
Intervention  Sleep hygiene awareness program  Students will be made aware of importance of following sleep hygiene for their better mood as well as academic performance. There will be almost 3-4 educational sessions in 1st and 2nd week of interaction and then the students will be followed up through reminders on their parents mobile through sms, watsapp or through mobile application to be developed indigenously in this program to receive feedback about the routine of sleep/food/excercise being followed by the students through their parents 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  - Students of classes 6th to 12th  
 
ExclusionCriteria 
Details  - Students unwilling /uninterested to participate/unable to give assent.
- unable to get parental consent.
- Students absent on two subsequent days from the school, on the days of invitation to participate in the study.
- Students on any long term medicine like for epilepsy, ADHD, pulmonary disease, diabetes etc.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Transition of mood (depression/anxiety/stress) from domain 2 (moderate, sever, extremely sever grade) to domain 1 (Normal/Mild grade)  week-8 week 
 
Secondary Outcome  
Outcome  TimePoints 
difference in sleep hours, pediatric daytime sleepiness, and adolescent sleep hygiene scale   At week 8 
 
Target Sample Size   Total Sample Size="2760"
Sample Size from India="2760" 
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)   01/07/2022 
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="2"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Background:  During adolescence, children undergo biological/physiological changes with sleep being no exception. Children, who prefer going to bed early, try to delay their bedtime as an adolescent. Late night activities including engagement on social media, internet and television also contribute for delayed sleep. Almost fixed rise time to catch early morning schools further adds to sleep loss though the total sleep requirement remains between 8.25 to 9.2 hours per night for optimal daytime alertness. Sleep deprivation manifests as mood disturbances, poor academic performance, addictions and road accidents.

            Novelty: This study will integrate the assessment of the existing sleep habits/beliefs of adolescents further educating the students for sleep hygiene practices and evaluating the change in their mood and sleep routines. This will help the educators and parents to ascertain an easy to practice habit which may improve the academics and mood of adolescent students.

            Objectives:

(1) To explore the beliefs/perceptions/prevalent practices about the existing sleep habits.

(2) To quantify the key determinants influencing their sleep practices.

 (3) To evaluate the effect of sleep hygiene awareness drive among adolescents in terms of change in their mood and sleep routines.

            Methods: It will be an open labelled cluster randomized control trial where one group will receive the interventional package of sleep hygiene along with healthy eating and exercise while the control group will be provided with package of healthy eating and exercise.

Expected Outcome: Change in the awareness for sleep hygiene habits towards improvement in mood, sleep routines and academic performance.

 
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