| CTRI Number |
CTRI/2025/07/091467 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Process of Care Changes
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effect of exposure to a children’s play area in the common pre-operative area on anxiety levels of adult patients undergoing surgery |
|
Scientific Title of Study
|
Effect of exposure to a paediatric play area in the common pre-operative room on anxiety levels of adult 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, Uttrakhand,249203, |
|
|
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, 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 |
| Comparator Agent |
Conventional pre-op room |
Conventional pre-op room, with case to case use of children specific toys/ anxiolysis |
| Intervention |
Paediatric Play Area in the common pre operative room |
A Paediatric Play Area created in the common adult-paediatric pre-op room of the operation theatre complex. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All consenting adult patients aged 18-70 years of age, of both genders, ASA 1-3, undergoing elective surgery. |
|
| ExclusionCriteria |
| Details |
Emergency surgery, ASA 4 or more; patients with intellectual or developmental disabilities or neurological impairment of any kind. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Amsterdam preoperative anxiety and information
Scale (APAIS) (4-20) |
Baseline measurement will be taken in the evening prior, during pre-op visit. Main outcome measured just before taking into the OT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Requirement of anxiolysis medication (intravenous) |
At time of induction |
| Post operative pain score: Numerical rating scale |
After arrival in the PACU |
| Total opioid requirement intraoperative |
End of surgery |
| Haemodynamic parameters (HR, BP, RR) |
At preop visit, on entry to pre op room, on entry to OT and in post op care unit (PACU). |
| Peri-operative satisfaction (Likert scale 1-5) |
In the PACU |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
31/07/2025 |
| 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 Yet Recruiting |
| 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
|
Pre-operative anxiety
is a natural and expected reaction in patients who are scheduled to undergo
surgery. Although well described in literature, this aspect is often
undiagnosed and undetected, with anxiolysis interventions only in those who
manifest extreme symptoms, or those who express anxiety overtly to the
physicians. Pre operative anxiety in adult patients has been found to be as
high as 52%. Pharmacological and non-pharmacological techniques have been
described in literature to decrease anxiety. At various institutes such
as ours, there is a common adult and paediatric pre-operative holding area of
the operation theatre. This offers a unique opportunity to set up a demarcated
paediatric play area in this common area, where paediatric patients can play and
interact with other paediatric patients. We intend to analyse the effect of
this play area on adult patient’s anxiety levels, with the hypothesis that
after implementing this quality improvement intervention the anxiety levels
will be lower than pre intervention group of patients. |