| CTRI Number |
CTRI/2022/01/039418 [Registered on: 14/01/2022] Trial Registered Prospectively |
| Last Modified On: |
24/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A comparison of quality of sleep during before and after surgery in patients admitted in surgical wards |
|
Scientific Title of Study
|
A comparison of sleep quality during pre and post surgery period in patients admitted in surgical wards |
| Trial Acronym |
SQSP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja |
| Designation |
Postgraduate student |
| Affiliation |
Department of Anaesthesia and Intensive Care, VMMC and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesia and Intensive Care, VMMC and Safdarjung Hospital, New Delhi, South Delhi
South
DELHI
110029
India |
| Phone |
9818325651 |
| Fax |
|
| Email |
pooja13ranakoti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhu Dayal |
| Designation |
Professor and Specialist Grade I |
| Affiliation |
Department of Anaesthesia and Intensive Care, VMMC and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesia and Intensive Care, VMMC and Safdarjung Hospital, New Delhi, South Delhi
South
DELHI
110029
India |
| Phone |
9811271996 |
| Fax |
|
| Email |
drmadhudayal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja |
| Designation |
Postgraduate student |
| Affiliation |
VMMC and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesia and Intensive Care, VMMC and Safdarjung Hospital, New Delhi, South Delhi
South
DELHI
110029
India |
| Phone |
9818325651 |
| Fax |
|
| Email |
pooja13ranakoti@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital New Delhi |
| Address |
VMMC and Safdarjung Hospital, New Delhi |
| 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 |
| Dr Pooja |
VMMC and Safdarjung Hospital, New Delhi |
Department of Anaesthesia and Intensive care, VMMC and Safdarjung Hospital, New Delhi,110029
South
DELHI |
9818325651
pooja13ranakoti@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: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults, age between 18 year to 65 years undergoing general surgery |
|
| ExclusionCriteria |
| Details |
1) Patients admitted in Intensive Care Unit.
2) Patients-
a) diagnosed with neurological and cognitive deficit, dementia, confusion, any psychiatric illness or insomnia.
b) who have undergone surgeries within past 12 month.
c) with history of long term use of alcohol and substance abuse in any form. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep quality assessed by Pittsburg Sleep Quality Index(PSQI) |
Pre-operative period, post-operative : 24 hours and 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of factors like age, gender, nature of surgery, type of anaesthesia, type of room (side room/ general ward), bedtime sleep medication on sleep quality |
Pre-operative period and post-operative 24 hours. |
| Day time sleepiness by using Epworth Sleepiness Scale(ESS) |
Pre-operative period, post-operative : 24 hours and 4 weeks. |
| Pain assessed by Visual Analogue Scale(VAS) |
Pre-operative period, post-operative : 24 hours and 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
14/02/2022 |
| 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 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
|
Perioperative care aims at preparing patients both physically and psychologically for surgical procedure and early recovery and ambulation post op, further studies are required on sleep quality, factor affecting it during hospital stay to improve patient care and surgical experience as a whole. The purpose of this study is to compare the quality of sleep during pre- and post- surgery period in patients admitted in general surgical wards. |