| CTRI Number |
CTRI/2025/11/098176 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of pre surgery sleep quality on the post surgery pain in children undergoing surgery. |
|
Scientific Title of Study
|
Impact of Preoperative Sleep Quality on Postoperative Pain and Recovery in Children Undergoing Elective Surgery: A Prospective Observational Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Arthav Shrikishan Ghule |
| Designation |
MBBS Student |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology, AIIMS Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9322912848 |
| Fax |
|
| Email |
202301034@aiimsrishikesh.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mridul Dhar |
| Designation |
Associate Professor, Anaesthesiology |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology, AIIMS Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9717778374 |
| Fax |
|
| Email |
mriduldhar87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mridul Dhar |
| Designation |
Associate Professor, Anaesthesiology |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology, AIIMS Rishikesh.
UTTARANCHAL
249203
India |
| Phone |
9717778374 |
| Fax |
|
| Email |
mriduldhar87@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand, 249203 |
|
|
Primary Sponsor
|
| Name |
Dr Mridul Dhar |
| Address |
Department of Anaesthesiology, AIIMS Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand, 249203 |
| Type of Sponsor |
Other [Guide of PI] |
|
|
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 Mridul Dhar |
AIIMS Rishikesh |
Department of Anaesthesiology, AIIMS Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand, 249203
Dehradun
UTTARANCHAL |
9717778374
mriduldhar87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Rishikesh Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2, Children undergoing elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Diagnosed sleep disorders or neurodevelopmental conditions
Emergency surgeries
Use of sedatives/psychotropic drugs pre-operatively
Children unable to be assessed using FLACC (e.g., prolonged unconsciousness)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| FLACC score post op |
30 mins, 2h, 6h, and 24h post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PACU stay duration (in minutes) |
Post operative |
| Time to ambulation (in hours) |
Post operative |
| Analgesic requirement (number and type of doses) |
Intra-operative |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
08/12/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Sleep is vital for
recovery and emotional regulation in children. Disrupted sleep before surgery may heighten
pain perception and delay recovery.
Adult studies have demonstrated that poor preoperative sleep is associated with increased postoperative pain,
prolonged post-anaesthesia care unit (PACU) stay, and
higher analgesic needs. However, similar
data in paediatric patients are limited
and relatively unexplored.
Younger children are particularly vulnerable to perioperative stress and have immature pain-coping mechanisms. Poor sleep may further compromise their recovery, but it is rarely assessed in preoperative settings. Understanding this link may allow early identification of children at risk for adverse outcomes
and enable timely non-pharmacological
or pharmacological interventions.This study aims to assess the association between preoperative sleep quality and postoperative pain and recovery
outcomes in children
aged 4 to 7 undergoing elective surgery under general
anaesthesia.
This study may establish poor sleep as a modifiable risk factor for postoperative
pain in children. The findings could support routine preoperative sleep screening and contribute to improving pediatric
recovery outcomes.
|