| CTRI Number |
CTRI/2025/07/089946 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effect of a children’s play area in the common pre-operative area on anxiety levels of children undergoing surgery |
|
Scientific Title of Study
|
Effect of a children’s play area in the common pre-operative room on anxiety levels of paediatric patients undergoing elective surgery: a quasi-experimental 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 |
Mridul Dhar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology, AIIMS Rishikesh, Uttarkhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9717778374 |
| Fax |
|
| Email |
mriduldhar87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mridul Dhar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology, AIIMS Rishikesh, Uttarkhand
UTTARANCHAL
249203
India |
| Phone |
9717778374 |
| Fax |
|
| Email |
mriduldhar87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mridul Dhar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology, AIIMS Rishikesh, Uttarkhand
UTTARANCHAL
249203
India |
| Phone |
9717778374 |
| Fax |
|
| Email |
mriduldhar87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, AIIMS Rishikesh |
|
|
Primary Sponsor
|
| Name |
Dr Mridul Dhar |
| Address |
Department of Anaesthesiology, AIIMS Rishikesh |
| Type of Sponsor |
Other [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 |
| Mridul Dhar |
AIIMS Rishikesh |
Department of Anaesthesiology, AIIMS Rishikesh
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 |
| Comparator Agent |
Conventional pre-op room |
Conventional pre-op room, with case to case use of children specific toys/ anxiolysis |
| Intervention |
Paediatric Play Area |
A Paediatric Play Area created in the common adult-paediatric pre-op room of the operation theatre complex. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2, undergoing elective surgery whose parents are willing for them to participate in the study. |
|
| ExclusionCriteria |
| Details |
Emergency surgery, ASA 3 or more; patients with intellectual or developmental disabilities, and those not accompanied by parents. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Yale preop anxiety score (MYPAS) |
Baseline measurement will be taken in the evening prior, and main outcome just before taking into OR/ OT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Requirement of pre-medication |
at the time of taking into OT |
| Post operative pain score: FLACC score/ NRS (as per age) in the PACU |
15 mins post PACU arrival |
| Total opioid requirement intraoperative |
End of surgery |
| Hemodynamic parameters (HR, BP, RR, SPO2) |
At preop ward visit, on entry to pre op room, on entry to OT and in PACU. |
| Parents satisfaction (Likert scale): |
After separation from the child in the pre-operative area, and in the post op care unit (either or both parents). |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
14/07/2025 |
| 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="1"
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
|
The peri-operative
experience can be quite distressing, more so in paediatric patients.
Pre-operative anxiety can have long term psychological effects, and behavioral
issues even as adults. Hospitals
taking care of paediatric patients, especially those undergoing surgery, should
strive to create a friendlier environment for the child as well as the parents. Numerous interventions have been described to decrease paediatric
anxiety including use of audio-visual aids and technology, toys, use of
medications as well as alternative therapies such as hypnosis and music therapy. Many organizations which are not dedicated paediatric centers, often
have common pre-operative areas for adult and paediatric patients. In such
cases, dedicated and focused paediatric centric work flow is often difficult to
achieve. This is also affected by financial constraints and allocation of
funds. This study is planned as a quality improvement initiative at our
institute to create a demarcated paediatric friendly area in the common
pre-operative rooms of various OT complexes, with the purpose to investigate
the clinical effects on the paediatric patients. This study may be able to
generate data, which can guide organizations in improving the perioperative
experience of the child as well as the family. The hypothesis is that in the post intervention (paediatric play area) implementation period anxiety levels of paediatric surgical patients will be lesser than those before the creation of paediatric play area in the common pre op rooms. |