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
|
|
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
|
|
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. |