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

NCT07760571 | Completed

• 1 other identifier: XiaoWang
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anxiety; Augmented Reality; Child; Preoperative Care; Tonsillectomy; Clinical implications

Outcome Measures

Primary Outcomes (7)

• The change from T0( in the waiting room ) the scores of anxiety of change at T1(entering the operating room)

  The outcome was measured by Modified Yale Preoperative Anxiety Scale-Short Form（mYPAS -SF),it is an observational behavioral medical scale, which can be used in surgical children to assess the preoperative anxiety level. mYPAS included 5 parts (mental state, language, emotional expression, arousal state, and dependence on parents).Each item of the scale corresponds to a different score. During the evaluation, the children's behaviors correspond to the corresponding items. The children's behaviors are divided into 1-4 grades or 1-6 grades. After conversion, the total score is 22.92-100 point. The lower the score, the lower the anxiety level of the child, and vice versa.

  From baseline assessment in the waiting room (T0) to entry into the operating room (T1), assessed over approximately 30 to 40 minutes.

• The change from T1( entering the operating room)the scores of anxiety of change at T2( immediately before induction)

  The outcome was measured by Modified Yale Preoperative Anxiety Scale-Short Form（mYPAS -SF),it is an observational behavioral medical scale, which can be used in surgical children to assess the preoperative anxiety level. mYPAS included 5 parts (mental state, language, emotional expression, arousal state, and dependence on parents).Each item of the scale corresponds to a different score. During the evaluation, the children's behaviors correspond to the corresponding items. The children's behaviors are divided into 1-4 grades or 1-6 grades. After conversion, the total score is 22.92-100 point. The lower the score, the lower the anxiety level of the child, and vice versa.

  From entry into the operating room (T1) to immediately before induction of anesthesia (T2), assessed over approximately 5 to 15 minutes.

• The change from T0(in the waiting room ) the heart rate of change at T1( entering the operating room)

  The evaluation heart rate was performed by the same portable electronic sphygmomanometer (OMRON HEM-7124). The vital signs in the operation room were measured by the same ECG monitor (Minray BeneView T8).The heart rate was measured by beats per minute.

  From baseline assessment in the waiting room (T0) to entry into the operating room (T1), assessed over approximately 30 to 40 minutes.

• The change from T1( entering the operating room)the heart rate of change at T2(before induction of anesthesia)

  The evaluation heart rate was performed by the same portable electronic sphygmomanometer (OMRON HEM-7124). The vital signs in the operation room were measured by the same ECG monitor (Minray BeneView T8).The heart rate was measured by beats per minute.

  From entry into the operating room (T1) to immediately before induction of anesthesia (T2), assessed over approximately 5 to 15 minutes.

• The change from T0(in the waiting room ) the systolic blood pressure of change at T1( entering the operating room)

  The evaluation systolic blood pressure was performed by the same portable electronic sphygmomanometer (OMRON HEM-7124). The vital signs in the operation room were measured by the same ECG monitor (Minray BeneView T8). The systolic blood pressure was measured by mmHg.

  From baseline assessment in the waiting room (T0) to entry into the operating room (T1), assessed over approximately 30 to 40 minutes.

• The change from T1( entering the operating room)the systolic blood pressure of change at T2(before induction of anesthesia)

  The evaluation systolic blood pressure was performed by the same portable electronic sphygmomanometer (OMRON HEM-7124). The vital signs in the operation room were measured by the same ECG monitor (Minray BeneView T8).The systolic blood pressure was measured by mmHg.

  From entry into the operating room (T1) to immediately before induction of anesthesia (T2), assessed over approximately 5 to 15 minutes.

• The degree of cooperation of children during anesthesia induction

  The outcome was measured by the Induction Compliance Checklist , There are 11 items in total, with scores ranging from 0 to 10 points. A score of 0 points means that the induction was successful without any uncooperative behavior; 10 points mean that the induction failed, that is, the child was completely passive and the degree of cooperation was very poor. If the child has the same condition as the item on the scale, the child can get 1 point, and the points were added up to get the final total score. The lower the total score, the better the cooperation.

  At the time point immediately before induction of anesthesia (T2), assessed approximately 5 to 15 minutes after entry into the operating room.

Study Arms (2)

Screen-delivered augmented-reality group

EXPERIMENTAL

On the basis of routine preoperative care (including a preoperative visit, psychological support, and a child-friendly waiting room), children in this group watched a 30-40-minute augmented-reality animation on a mobile television (Xiaomi L43RA-RA). The sound was kept within 35-80 dB and adjusted according to the child's feedback. A study nurse delivered and monitored the intervention.

Other: Screen-delivered augmented-reality group

Usual Care Group

ACTIVE COMPARATOR

Children in the control group received routine preoperative visits, psychological support, and standard care in a child-friendly waiting room with cartoon decorations and toys. No additional digital or behavioral intervention was administered.

Other: Usual Care Group

Interventions

Screen-delivered augmented-reality group OTHER

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.

Screen-delivered augmented-reality group

Usual Care Group OTHER

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.

Usual Care Group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children aged 3-12 years who were scheduled for elective adenotonsillectomy and had American Society of Anesthesiologists physical status I or II.
• The guardian understands the research content and signs the written informed consent; for children who can understand the research explanation, the appropriate language is used to explain and confirm their willingness to participate

You may not qualify if:

• Emergency surgery or concurrent other surgeries.
• Before anesthesia induction, sedative or analgesic drugs are used due to clinical needs.
• There are records in the medical history that may affect participation, observation or behavioral assessment, such as neurodevelopment, mental or cognitive conditions.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Related Publications (7)

• Jung MJ, Libaw JS, Ma K, Whitlock EL, Feiner JR, Sinskey JL. Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial. Anesth Analg. 2021 Mar 1;132(3):798-806. doi: 10.1213/ANE.0000000000005004.

  PMID: 32618627 RESULT

• Chen YJ, Wang CJ, Chen CW. Effects of virtual reality on preoperative anxiety in children: A systematic review and meta-analysis of randomised controlled trials. J Clin Nurs. 2023 Jun;32(11-12):2494-2504. doi: 10.1111/jocn.16394. Epub 2022 Jun 7.

  PMID: 35672942 RESULT

• Ooi K, Weale J. The effect of augmented reality on preoperative anxiety in children and adolescents: A randomized controlled trial. Comments on Chamberland et al. Paediatr Anaesth. 2024 May;34(5):482. doi: 10.1111/pan.14853. Epub 2024 Feb 2. No abstract available.

  PMID: 38303681 RESULT

• Carbo A, Tresandi D, Tril C, Fernandez-Rodriguez D, Carrero E. Usefulness of a virtual reality educational program for reducing preoperative anxiety in children: A randomised, single-centre clinical trial. Eur J Anaesthesiol. 2024 Sep 1;41(9):657-667. doi: 10.1097/EJA.0000000000002032. Epub 2024 Jun 24.

  PMID: 38916221 RESULT

• Birckhead B, Khalil C, Liu X, Conovitz S, Rizzo A, Danovitch I, Bullock K, Spiegel B. Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study. JMIR Ment Health. 2019 Jan 31;6(1):e11973. doi: 10.2196/11973.

  PMID: 30702436 RESULT

• Bandyopadhyay S, Kaur M, Sinha R, Muthiah T, Ayub A, Subramaniam R. Effect of video distraction on preoperative anxiety scores in pediatric patients undergoing general anesthesia in ophthalmic daycare procedures: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2024 Jan-Mar;40(1):133-139. doi: 10.4103/joacp.joacp_236_22. Epub 2023 Dec 12.

  PMID: 38666175 RESULT

• Alharbi F, Alsaedi G, Alahmadi T, Alalawi S, Mulla R, Almohammadi R, Abulfaraj M. Effectiveness of digital storytelling and immersive technology interventions in reducing preoperative anxiety among children: a systematic review and meta-analysis. JMIR Pediatr Parent. 2026 Apr 28. doi: 10.2196/92880. Online ahead of print.

  PMID: 42053523 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The scheduled surgery date determined group assignment. Children scheduled on dates with odd day numbers received the intervention, and those scheduled on dates with even day numbers received usual care alone. Allocation was predictable, was not concealed, and assigned every child treated on a given date to the same group. Two trained nursing students who did not deliver the intervention completed outcome assessments. Investigators reported that both assessors remained unaware of allocation. Anxiety, heart rate, and blood pressure were recorded before exposure in the waiting room (T0), at operating-room entry (T1), and immediately before induction (T2). Induction cooperation was assessed at T2.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: An operating-room nurse conducted the standard preoperative visit on the day before surgery and provided psychological support. On the day of surgery, children arrived in a dedicated waiting room about 30 min before transfer. Venipuncture occurred there while one parent remained present. The room contained cartoon wall decorations and age-appropriate toys. During the 30-40-min wait, a study nurse offered reassurance, provided perioperative guidance, and answered questions. The accompanying parent left before anesthesia induction. In addition to usual care, intervention-group children watched the augmented-reality animation on the same mobile television (Xiaomi L43RA-RA) for 30-40 min. Sound was kept within 35-80 dB and adjusted in response to the child. A study nurse delivered and monitored the intervention.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 12, 2026
• Study Start: April 4, 2026
• Primary Completion: June 30, 2026
• Study Completion: July 10, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)