| CTRI Number |
CTRI/2022/01/039246 [Registered on: 07/01/2022] Trial Registered Prospectively |
| Last Modified On: |
05/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Natural therapy] |
| Study Design |
Other |
|
Public Title of Study
|
Eye mask and ear plug for sleep improvement |
|
Scientific Title of Study
|
An experimental study to assess the effectiveness of eye mask and ear plugs on sleep quality among patients undergoing cardiac surgeries at a selected critical care unit |
| Trial Acronym |
Sleep study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Arulpandian |
| Designation |
Nurse practitioner |
| Affiliation |
Narayana harudalaya college of nursing |
| Address |
Room no. 11,surya nagar, Kithaganahalli, Bommasandra Post, Bengaluru
Bangalore
KARNATAKA
560099
India |
| Phone |
7094225240 |
| Fax |
|
| Email |
arul13298@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Puvaneswari |
| Designation |
Professor |
| Affiliation |
Narayana hrudalaya college of nursing |
| Address |
Medical surgical nursing, Narayana Hrudayalaya college of nursing
No: 258/A, Bommasandra Industrial area, Hosur road anekal taluk.
Bangalore
KARNATAKA
560099
India |
| Phone |
9448126938 |
| Fax |
|
| Email |
puvaneswari.k.k@hrudayalayafoundation.org |
|
Details of Contact Person
Public Query
|
| Name |
Mr Arulpandian |
| Designation |
Nurse practitioner |
| Affiliation |
Narayana hrudalaya college of nursing |
| Address |
Room no. 11,surya nagar, Kithaganahalli, Bommasandra Post, Bengaluru.
Bangalore
KARNATAKA
560099
India |
| Phone |
7094225240 |
| Fax |
|
| Email |
arul13298@gmail.com |
|
|
Source of Monetary or Material Support
|
| Naraya Institute of cardiac science |
|
|
Primary Sponsor
|
| Name |
Mr Arulpandian |
| Address |
Room no. 11,first floor, surya nagar, sky international school near, kithaganahalli,Bommasandra post, bengalure-560099 |
| 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 |
| Arul pandian |
Narayana Institute of cardiac science |
Anekal, 258/A, Hosur Rd, Bommasandra Industrial Area, Bengaluru, Karnataka 560099
Bangalore
KARNATAKA |
7094225240
arul13298@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana health academic ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ear plugs and eye mask |
An experimental study to assess the effectiveness
of eye mask and ear plugs on sleep quality among
patients undergoing cardiac surgeries at a selected
critical care unit, Bangalore |
| Comparator Agent |
Ear plugs eye mask |
An experimental study to assess the effectiveness
of eye mask and ear plugs on sleep quality among
patients undergoing cardiac surgeries at a selected
critical care unit, Bangalore .Therapy will be provided two days.. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who
1.Are willing to participate.
2.Are above 20 years.
3.Are conscious.
4.Will undergo cardiac surgeries |
|
| ExclusionCriteria |
| Details |
Subjects who
1.Receive sedatives
2.Are on mechanical ventilator.
3.Has Visual and auditory disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep quality |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To associate the sleep quality with the baseline and clinical variables |
1 to 2 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/01/2022 |
| 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="0"
Months="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An experimental study to assess the effectiveness
of eye mask and ear plugs on sleep quality among
patients undergoing cardiac surgeries at a selected
critical care unit, Bangalore. |