An interventional study of Screen-delivered augmented-reality group and Usual Care Group in Tonsillectomy, Preoperative Care and Anxiety, sponsored by Central South University. Completed at 1 site in China. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Central South University · Not applicable, Interventional, and Supportive care
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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.
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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Central South University is the lead sponsor of 135 studies on the registry; 32 are open to participants now.
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children aged 3-12 years who were scheduled for elective adenotonsillectomy and had physical status I or II.
The guardian understands the research content and signs the written ; for children who can understand the research explanation, the appropriate language is used to explain and confirm their willingness to participate
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
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 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.
Time frame: 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.
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 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.
Time frame: 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.
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 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.
Time frame: 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.
Time frame: At the time point immediately before induction of anesthesia (T2), assessed approximately 5 to 15 minutes after entry into the operating room.
Plan to share: No — The process of data collection cost a lot of human and material resources, some of the data was privacy information of participants, and so on. Considering this, it is improper to share these data.
Ran from Apr 2026 to primary completion in Jun 2026, 2 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 2 months is below that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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