| CTRI Number |
CTRI/2022/11/047210 [Registered on: 11/11/2022] Trial Registered Prospectively |
| Last Modified On: |
10/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the effect of earplugs and eye masks with that of relaxing music on the sleep quality of critical patients |
|
Scientific Title of Study
|
Comparison of earplugs and eye mask with relaxing music on sleep quality in critically ill patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikha Teny |
| Designation |
Post Graduate Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital and Vardhman Mahavir Medical College, New Delhi, 110029,India
New Delhi
DELHI
110029
India |
| Phone |
9131275807 |
| Fax |
|
| Email |
shikhateny@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vandana Talwar |
| Designation |
Professor, Consultant and Head of Department |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital and Vardhman Mahavir Medical College, New Delhi, 110029,India
New Delhi
DELHI
110029
India |
| Phone |
9811352251 |
| Fax |
|
| Email |
drvandanatalwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vandana Talwar |
| Designation |
Professor, Consultant and Head of Department |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital and Vardhman Mahavir Medical College, New Delhi, 110029,India
New Delhi
DELHI
110029
India |
| Phone |
9811352251 |
| Fax |
|
| Email |
drvandanatalwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Safdarjung Hospital and Vardhman Mahavir Medical College, New Delhi, India |
|
|
Primary Sponsor
|
| Name |
Safdarjung Hospital and Vardhman Mahavir Medical College New Delhi India |
| Address |
Department of Anaesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital and Vardhman Mahavir Medical College, New Delhi, 110029,India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Shikha Teny |
Safdarjung Hospital and Vardhman Mahavir Medical College |
Department of Anaesthesia and Intensive Care, ground floor, main operation theatre building.
New Delhi
DELHI |
9131275807
shikhateny@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Earplugs and eye mask |
Group A participants will receive earplugs and eye mask and subjective sleep quality will be assessed by a stuctured sleep quality scale based on Richards Campbell Sleep Questionairre for two days |
| Comparator Agent |
No Intervention |
Group C participants will not receive any intervention and subjective sleep quality will be assessed by a stuctured sleep quality scale based on Richards Campbell Sleep Questionairre for two days |
| Intervention |
Relaxing Music( Rainfall Sound) |
Group B participants will be made to hear rainfall sound and subjective sleep quality will be assessed by a stuctured sleep quality scale based on Richards Campbell Sleep Questionairre for two days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Duration of stay in the ICU more than or equal to 48 hrs
2.Stable haemodynamics
3.Glasgow Coma Scale(GCS) more than or equal to 12
4.Ability to communicate and understand Hindi or English
5.Lucid and capable to understand questions |
|
| ExclusionCriteria |
| Details |
1.Trauma/surgery to head, eyes, ears
2.Known psychiatric disease
3.Patients with hearing impairement/Vision impairement
4.Confusion, dementia, delirium at the time of admission
5.No sedative or narcotics in last 24 hrs
6.Baseline disturbed sleep pattern when patient was at home |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare earplugs and eye mask with relaxing music on sleep quality in critically ill patients using Richard Campbell Sleep Questionairre |
The participants will be assessed for 2 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare earplugs and eye mask with relaxing music on:
1.Factors preventing sleep
2.Factors promoting sleep
in critically ill patients |
The participants will be assessed for 2 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
12/11/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Randomised Control Trial to compare earplugs and eye mask with relaxing music on sleep quality in critically ill patients. Subjective sleep quality will be assessed by a structured sleep quality scale based on Richard Campbell Sleep Questionairre in critically ill patients. |