Skip to main content
OpenTrials
Completed

NCT Number: NCT07760571

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tonsillectomy Anxiety Anxiety Disorders Mental Disorders Preoperative Care

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

About this study

The study was a prospective, single-center, outcome-assessor-blinded, non-randomized controlled study.Researchers recruited subjects from one Central South University-affiliated general tertiary hospital in Changsha, Hunan province, China. And the whole trail was on the basis of the CONSORT statements.Study procedures were approved by the institutional review boards of all participating centers before data collection began. All patients were screened by researchers for eligibility and then enrolled in the study if eligible and if the provided consent.

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.

Children were eligible if they were aged 3-12 years, scheduled for elective adenotonsillectomy, and classified as American Society of Anesthesiologists physical status I or II. The study excluded emergency or concomitant procedures, preinduction sedative or analgesic medication, and documented neurodevelopmental, psychiatric, or cognitive conditions that could affect participation or behavioral assessment.A research team member explained the study and confirmed that withdrawal would not affect clinical care. A parent or legal guardian provided written informed consent.

A multidisciplinary team of pediatric, anesthesia, and nursing staff developed the intervention with reference to methodological recommendations for virtual-reality trials. The team reviewed relevant evidence, identified common perioperative sources of anxiety, and refined a health-education script through multidisciplinary discussion.

Panoramic footage of the operating-room environment provided the visual setting. Postproduction integrated virtual animation with the recorded environment. The sequence followed the child's pathway through surgical-suite entry, preparation, transfer, the period before induction, post anesthesia recovery, and return to the ward.

In the control group,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.

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.

Training covered the purpose and scoring of each instrument and included standardized practice examples. It continued until interrater agreement reached a kappa of at least .80.

The primary outcome was preoperative anxiety measured with the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF). Secondary outcomes were induction cooperation, heart rate, and blood pressure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

  7. The degree of cooperation of children during anesthesia induction

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

    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.

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Official study title

Screen-delivered Augmented-reality Preparation and Anxiety Before Pediatric Adenotonsillectomy in China: a Prospective Non-randomized Controlled Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.