| CTRI Number |
CTRI/2025/07/090088 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Human ] |
| Study Design |
Other |
|
Public Title of Study
|
To assess effectiveness of use of earplugs and eyemask during sleep among hospitalized patient |
|
Scientific Title of Study
|
Effectiveness of earplugs and eyemask for 3 days to improve sleep quality among patients in medicine ward compared to patients receiving routine care: A randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jasmine gamdik |
| Designation |
Student |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Jawaharlal institute of medical education and research,college of nursing,puducherry
Jawaharlal institute of medical education and research, college of nursing ,605006, puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7640092835 |
| Fax |
|
| Email |
gamdikjasmin200@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MJ Kumari |
| Designation |
Professor cum principal (Acting) |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Jawaharlal institute of postgraduate medical education and research ,Department of medical surgical nursing , college of nursing ,puduchery
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894595420 |
| Fax |
|
| Email |
kumari_mj@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MJ Kumari |
| Designation |
Professor cum principal (Acting) |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Jawaharlal institute of postgraduate medical education and research ,Department of medical surgical nursing , college of nursing ,puduchery
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894595420 |
| Fax |
|
| Email |
kumari_mj@ymail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund comittee , Jawaharlal institute of postgraduate medical education and research ,puducherry -605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Intramural fund comittee, Jawaharlal institute of postgraduate medical education and research ,puducherry -605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jawaharlal institute of postgraduate medical education and research puducherry |
Intramural fund comittee, Jawaharlal institute of postgraduate medical education and research ,puducherry -605006 |
| 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 |
| Jasmine gamdik |
Jawaharlal institute of postgraduate medical education and research |
Medicine ward ,room no -42 Jawaharlal institute of postgraduate medical education and research pondicherry - 605006, pondicherry
Pondicherry
PONDICHERRY |
07640092835
gamdikjasmin200@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics comittee for Human studies, Jawaharlal institute of postgraduate Medical education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y999||Unspecified external cause status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Earplugs and eyemask |
The patient in interventional group will be provided with earplugs and eyemask for three nights , on the third day , the intervention group will be assessed for sleep quality using sleep quality scale |
| Comparator Agent |
Routine care |
Patients in control group will recieve routine care and be observed for 3 nights ., after 3 nights thay will be assessed for sleep quality using sleep quality scale |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 and above
patients who are admitted in medicine ward length of stay more than 4 days |
|
| ExclusionCriteria |
| Details |
Use hearing aids
Hemodianamically unstable
Patient on sedative
Patients with obstructive sleep apnea |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of earplugs and eyemask to improve sleep quality among patients during hospital stay |
9pm to 6am for 3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of earplugs and eyemask to improve sleep quality among patients during hospital stay |
3 days |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
05/07/2025 |
| 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="6"
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 is randomised controlled trial to assess the effectiveness of earplugs and eyemask to improve sleep quality among patients who are hospitalised for more than 4 days , total 106 samples out of which 53 intervention group and 53 control group , group allocation will be done by SNOSE techniques , intervention group will be provided with earplugs and eyemask for3 days during sleep whereas control group will be given only routine care after 3 days both the groups will be assessed for sleep quality using sleep assessment scale |