| CTRI Number |
CTRI/2025/11/097984 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
HRAD scale validation for preoperative anxiety in Indian children |
|
Scientific Title of Study
|
Validation of HRAD scale for assessment of preoperative anxiety in Indian children |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D Jeeneshan |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Department of Anesthesia and Intensive care
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7010544453 |
| Fax |
|
| Email |
shan2brothers@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aakriti Gupta |
| Designation |
Associate Professor |
| Affiliation |
PGIMER |
| Address |
Department of Anesthesia and Intensive care
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8194800554 |
| Fax |
|
| Email |
aakriti1988.ag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aakriti Gupta |
| Designation |
Associate Professor |
| Affiliation |
PGIMER |
| Address |
Department of Anesthesia and Intensive care
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8194800554 |
| Fax |
|
| Email |
aakriti1988.ag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia and Intensive Care,4th Level, Nehru Hospital,PGIMER,Chandigarh,India-160012 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia and Intensive care |
| Address |
4th Level Nehru hospital,
PGIMER
Chandigarh -160012
India
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 D Jeeneshan |
PGIMER |
OT complex,
6th floor
Advanced Paediatric centre,
PGIMER
And
OT complex,
4th Floor,
Advanced Eye Centre,
PGIMER, Chandigarh
Pincode-160012
PGIMER,Chandigarh
Chandigarh
CHANDIGARH |
7010544453
shan2brothers@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh,Institutional Ethics committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (2) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (3) ICD-10 Condition: K00-K95||Diseases of the digestive system, (4) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, (5) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (6) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grades 1 or 2 planned for elective surgery with general anesthesia via inhalational induction
2.Both out-patients and in-patients |
|
| ExclusionCriteria |
| Details |
Children requiring parental presence at induction, children planned to undergo intravenous anaesthetic induction, emergency surgery, children with neurodevelopment anomalies and children with visual or hearing impairment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess concurrent validity of HRAD+ scale for pediatric preoperative anxiety and cooperation by comparing with mYPAS and ICC score, respectively. |
Patient will be assessed on the day of surgery and after 30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess construct validity of HRAD+ scale.
2. To determine the intra- and inter-rater reliability of the HRAD± scale.
3. To determine the association between children’s anxiety level and their cooperation.
4. To determine the validity of the score in premedicated children. |
1-a)admission into preoperative holding area (T1), b) entering into the operating room (T2) and c) anaesthetic induction (T3).
2-The intra-rater reliability will be measured by scoring the same videos by Attending Anesthetist(A),First study Researcher(R1) and Second study Researcher (R2) after a time gap of 30 days.
3-The inter-rater reliability will be determined between HRAD scores of A, R1 and R2 on same day and after 30 days as well. |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
05/12/2025 |
| 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="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 investigator will interact with the child and family prior to the surgical procedure and parents/guardians of children enrolled in the study will be explained about the study protocol. The demographic details (age, sex, height, weight) and other clinical details like ASA status, history of previous surgery will be noted. The use of methods for alleviation of anxiety like premedication administration, and non-pharmacological measures like distraction techniques or OR tours will be at the discretion of the attending anaesthetist and will be documented by the investigator. The included children will be videotaped for two minutes each at three time points: a) admission into preoperative holding area (T1), b) entering into the operating room (T2) and c) anaesthetic induction (T3). All the videos will be scored for assessment of anxiety using mYPAS score and HRAD+ scale and the induction video for cooperation using ICC score and HRAD+ scale. Real time assessment for HRAD scoring will be done by the attending anesthesiologist (A) and the first study researcher (R1). The videos will be assessed for mYPAS and ICC scores by R1 and HRAD scoring by the second study researcher (R2) on the same day. The recorded videos for each patient will be assessed again by A, R1 and R2 for HRAD scoring after 30 days. The primary outcome of the study will be to evaluate the concurrent validity of the HRAD± scale, which is determined by its agreement with established reference scales.This can be assessed by measuring anxiety and cooperation with HRAD± scale and correlating their scores with mYPAS and ICC respectively. The mean HRAD+ scores of A, R1 and R2 will be compared to the mYPAS and ICC scoring done by R1. All the assessors would be blinded to the score determined by one another. Secondary outcomes: The construct validity of the HRAD± scale—which determines whether it accurately measures the underlying attribute it is meant to measure-can be assessed by examining score patterns under progressively heightened stress conditions, i.e evaluating the children’s anxiety at admission into preoperative holding area (T1),operating room entry(T2) and anaesthetic induction (T3). b) The intra-rater reliability will be measured by scoring the same videos by A, R1 and R2 after a time gap of 30 days. The inter-rater reliability will be determined between HRAD scores of A, R1 and R2 on same day and after 30 days as well. For correlation analysis,the anxiety score of 0-29 measured by mYPAS will correspond to an HRAD± score of 0 (Happy) and 1 (Relaxed); and a mYPAS score of 30-100 will correspond to an HRAD± score of 2 (Anxious) and 3 (Distressed), based on an earlier published study in our set-up.32 For analyzing cooperativity,an ICC score of 0–2 will correspond to an HRAD± score of + (cooperative), and an ICC score of 3–10 will correspond to an HRAD± score of – (uncooperative), based on an earlier study. |