Screen-delivered Augmented-reality Preparation and Anxiety Before Pediatric Adenotonsillectomy in China

NCT07760571 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-12

No results posted yet for this study

Summary

Whether a nonwearable, screen-delivered augmented-reality animation adds measurable benefit to supportive pediatric perioperative care remains uncertain. Preoperative anxiety has been reported in up to 60% of children and can compromise cooperation during anesthesia induction . Higher anxiety has also been associated with adverse postoperative behavior and, after adenoid or tonsillar surgery, with emergence agitation and pain . These consequences make anxiety reduction clinically relevant, particularly during the rapid transition from the waiting area to induction.

Nonpharmacological preparation is central to child-centered perioperative care. Recent reviews encompass education, therapeutic play, caregiver presence, distraction, and digital interventions, but they also show substantial clinical and methodological heterogeneity. Meta-analyses suggest that virtual-reality interventions can reduce anxiety and may improve cooperation, although pooled effects vary across devices, comparators, and study quality . The evidence therefore supports promise rather than a single optimal format.

Recent trials illustrate both the potential and the contextual dependence of digital preparation. Procedure-specific trials in adenotonsillectomy have reported benefits from visual explanation and virtual-reality cartoons. Virtual-reality education has been associated with lower anxiety and better induction cooperation . An immersive operating-room digital twin also outperformed an otherwise similar two-dimensional video in one randomized trial. Video distraction combined with caregiver presence reduced anxiety during transport and mask introduction , whereas tablet distraction produced anxiety outcomes similar to midazolam in preschool children .

Delivery mode alone, however, does not explain the observed effects. Another trial found similarly low anxiety with three-dimensional virtual reality and two-dimensional video when caregivers remained present . A short animation added to verbal preparation showed no statistically significant between-group difference, and immediate virtual-reality exposure was more useful than exposure several days earlier . After correction of the published abstract, head-mounted augmented reality was associated with lower anxiety at induction, but fitting, tolerance, and workflow differ from shared-screen delivery . Evidence remains limited for a longer, nonwearable animation delivered within supportive usual care to children undergoing adenotonsillectomy.

The investigators in this study therefore conducted a prospective nonrandomized controlled study of children undergoing adenotonsillectomy at a tertiary hospital in China. The investigators evaluated whether adding a 30-40-min screen-delivered augmented-reality animation to supportive usual care was associated with anxiety trajectories and induction cooperation. By assessing children at three perioperative transitions, the study distinguishes attenuation of rising distress from complete prevention. The study report these behavioral outcomes and then interpret their clinical relevance within the constraints of date-based allocation.

Conditions

  • Tonsillectomy
  • Preoperative Care
  • Anxiety

Interventions

OTHER

Screen-delivered augmented-reality group

Before surgery, subjects in the intervention group were asked to watch a 30-40-minute augmented-reality animation depicting the child's surgical pathway (from surgical-suite entry to recovery) to reduce anxiety before surgery and induction of anesthesia. The animation was delivered on a shared mobile television with sound controlled at 35-80 dB.

OTHER

Usual Care Group

Participants in the control arm received routine preoperative visits and conventional care only. No additional digital, behavioral, or pharmacological intervention was provided for the purpose of this study.

Sponsors & Collaborators

  • Central South University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-04
Primary Completion
2026-06-30
Completion
2026-07-10

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07760571 on ClinicalTrials.gov