| CTRI Number |
CTRI/2025/08/092799 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF SLEEP DISTURBANCE, SLEEP HYGIENE, AND DIGITAL ADDICTION |
|
Scientific Title of Study
|
EFFECT OF SLEEP DISTURBANCE, SLEEP HYGIENE, AND DIGITAL ADDICTION ON ACADEMIC PERFORMANCE AMONG UNDERGRADUATE NURSING STUDENTS. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sukanya Kundu |
| Designation |
Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of fundamentals of Nursing
Manipal College of Nursing
Department of fundamentals of Nursing
Manipal College of Nursing
Udupi
KARNATAKA
576104
India |
| Phone |
8240283779 |
| Fax |
|
| Email |
sukanya.mconmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Radhika R Pai |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of fundamentals of Nursing
Manipal College of Nursing
Department of fundamentals of Nursing
Manipal College of Nursing
Udupi
KARNATAKA
576104
India |
| Phone |
08867785379 |
| Fax |
|
| Email |
radhika.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Melita Shelini |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Medical Surgical Nursing
Manipal College of Nursing
Department of Medical Surgical Nursing
Manipal College of Nursing
Udupi
KARNATAKA
576104
India |
| Phone |
8095976561 |
| Fax |
|
| Email |
shyli.mel@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sukanya Kundu |
| Address |
Manipal college of Nursing, MAHE, Manipal |
| 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 |
| Radhika R Pai |
Manipal College of Nursing |
Department of Fundamentals of Nursing
Manipal College of Nursing
Udupi
KARNATAKA |
08867785379
radhika.r@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nursing students of MCON (2nd, 3rd, 4th) year and Students of MSON (2nd, 3rd) year who are using mobile phone/iPad/laptop
• Can speak and understand English
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
• Nursing students of MCON (2nd, 3rd, 4th) year and Students of MSON (2nd, 3rd) year who are using mobile phone/iPad/laptop
• Can speak and understand English
• Are willing to take part in the study
|
|
| ExclusionCriteria |
| Details |
Nursing students who are not willing to take part in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Digital addiction
Sleep disturbance
Academic performance
Sleep hygiene
|
at baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study seeks to examine the prevalence of sleep disturbances, sleep hygiene practices, digital addiction, and academic performance among undergraduate nursing students. The findings are expected to provide insight into the extent of these issues within the current generation, thereby informing the development of targeted interventions to effectively address them in the future.
|