| CTRI Number |
CTRI/2024/07/069907 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Sleep quality in young college students of Bhopal city |
|
Scientific Title of Study
|
Assessment of sleep quality among young college students in Bhopal city a-cross sectional study
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajeshwari Mandloi |
| Designation |
post graduation scholar |
| Affiliation |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal |
| Address |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Department of swasthavritta and yoga, room no. 8
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8085811516 |
| Fax |
|
| Email |
mandloirajeshwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Trupti jain |
| Designation |
Lecturer |
| Affiliation |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal |
| Address |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Department of swasthvaritta room no.8
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7566832322 |
| Fax |
|
| Email |
trupatijain211@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Trupti jain |
| Designation |
Lecturer |
| Affiliation |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal |
| Address |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Department of swasthavritta room no.8
MADHYA PRADESH
462003
India |
| Phone |
7566832322 |
| Fax |
|
| Email |
trupatijain211@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrRajeshwari Mandloi |
| Address |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (m.p)india 462003
Nehru Nagar Kolar Bypass Road |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrRajeshwari Mandloi |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal Department of svasthawaritta Room no.8
Nehru Nagar Kolar Bypass Road
Bhopal
MADHYA PRADESH |
8085811516
mandloirajeshwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics CommitteePt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
assessment of sleep quality among young college student |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Subjects between the age group of 17 to 24 years of either sex
Subjects who are willing to join the survey study. |
|
| ExclusionCriteria |
| Details |
Subjects below the age 17 years and above 24 years
Subjects having any other severe systemic physical or mental illness.
Pregnant and lactating women.
Subjects who are not willing to join the survey study.
5. Subjects who are doing Night Shifts. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that this study effectively demonstrates the sleep quality among college going youngsters in Bhopal city.
|
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
08/08/2024 |
| 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="8"
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
|
Sleep is essential for mental, physical, social as well as
emotional development. This study will be designed as a
cross-sectional observational study and the sample will be selected by non-probability sampling technique. Quality
of Sleep will be assessed
on the basis of Pittsburgh Sleep
Quality Index Scale and stress will be assessed by PSS (Perceived Stress Scale
by Cohen). the
age group of 17 to 24 years of either Gender duration 8 months. It is
expected that this study effectively demonstrates the sleep quality among
college going youngsters in Bhopal city.
|