| CTRI Number |
CTRI/2019/04/018672 [Registered on: 18/04/2019] Trial Registered Prospectively |
| Last Modified On: |
06/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the quality of sleep among patients admitted in ICU |
|
Scientific Title of Study
|
Sleep quality among adult patients admitted in Intensive Care Units |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roselin Juliet Joice R |
| Designation |
PG in Adult Respiratory Care |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Respiratory Therapy
School of Allied Health Sciences
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9790275032 |
| Fax |
|
| Email |
roselinjohncmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh Unnikrishnan |
| Designation |
Head of the Department |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Respiratory Therapy
School of Allied Health Sciences
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9900404492 |
| Fax |
|
| Email |
ramesh.unnikrishnan@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Roselin Juliet Joice R |
| Designation |
PG in Adult Respiratory Care |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Respiratory Therapy
School of Allied Health Sciences
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9790275032 |
| Fax |
|
| Email |
roselinjohncmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Allied Health Sciences, MAHE, Manipal 576104 |
|
|
Primary Sponsor
|
| Name |
Roselin Juliet Joice R |
| Address |
Department of Respiratory Therapy
School of Allied Health Sciences
Manipal Academy of Higher Education, 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 |
| Roselin Juliet Joice R |
Kasturba Medical college Hospital |
Department of Respiratory Therapy
School of Allied Health Sciences
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA |
9790275032
roselinjohncmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R400||Somnolence, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients who are admitted in Adult intensive care unit for at least 24 hours
2. Patients who are oriented to time place and person
3. Both sexes above 18 years of age |
|
| ExclusionCriteria |
| Details |
Patients with preexisting sleep disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep quality in ICU patients |
24 hours after ICU admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Factors affecting sleep in Intensive care units |
24 hours after ICU admission |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2019 |
| Date of Study Completion (India) |
17/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a cross sectional study to assess the sleep quality of patients admitted to intensive care units after 24 hours of admission. sleep quality of patients at ICU are assessed using Richards campbell sleep questionnaire and factors affecting sleep are reported |