Validation of HRAD scale for assessment of preoperative anxiety in Indian children

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.