Comparison of distraction using virtual reality and augmented reality tools for reduction of anxiety of surgery in children.

Not Applicable

Not yet recruiting

• Conditions: Chronic atticoantral suppurative otitis media, (2) ICD-10 Condition: N433||Hydrocele, unspecified, (3) ICD-10 Condition: H028||Other specified disorders of eyelid, (4) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,

• Registration Number: CTRI/2023/08/056014
• Lead Sponsor: Maulana azad medical college

Brief Summary

Preoperative pediatric anxiety is common and can have negative psychological impact on children undergoing anaesthesia and surgery. Various audiovisual distraction techniques like Virtual reality have proven to be effective in lowering anxiety as assessed my modified yale perioperative scale(mYPAS). Augmented reality is a newer, interactive technology that allows users to simultaneously view the real world environment with digital image overlay. The aim of our study is to evaluate and compare virtual reality and augmented reality in pediatric patients aged 4-10 years old.

Our primary outcome is to assess change in preoperative anxiety from baseline to induction using mYPAS scale. Our secondary outcomes are to measure pediatric induction compliance using induction compliance checklist score, parental anxiety using state trait anxiety inventory score, parental satisfaction using parental and patient satisfaction questionnaires, time to loss of eyelash reflex and time to central miosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-08
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

ASA physical status I-III.

Exclusion Criteria

• 1.Patients with injuries to head and face that would interfere in wearing headsets.
• Skin infections and open wounds on face/head.
• Inability to visualise AR/VR applications.
• Patients in whom VR headsets do not fit appropriately.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in preoperative anxiety (mYPAS score).	Baseline to induction.

Secondary Outcome Measures

Name	Time	Method
Parental satisfaction using parental & patient satisfaction scores	after induction
Time to loss of eyelash reflex	after induction till loss of eyelash reflex
Parental anxiety using state trait anxiety inventory score. (STAI)	after induction.
Pediatric induction compliance using induction compliance checklist score.	During induction of general anaesthesia.
Time to central miosis	after induction till central miosis
Change in preoperative anxiety using mYPAS score.	during induction.

Trial Locations

Locations (1)

Lok nayak and associated hospitals; 🇮🇳 Central, DELHI, India

Lok nayak and associated hospitals

🇮🇳Central, DELHI, India

Dr Garvita Bhatnagar

Principal investigator

8095315303

garvitabhatnagar5@gmail.com