TonsillectomyNCT07760571
Screen-delivered Augmented-reality Preparation and Anxiety Before Pediatric Adenotonsillectomy in China
A study testing Screen-delivered augmented-reality group in people with Tonsillectomy and Preoperative Care, run by Central South University at 1 site in China.
Trial 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 . Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Tonsillectomy, Preoperative Care, Anxiety
- What is being tested?
- Screen-delivered augmented-reality group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2026to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
Official title: Screen-delivered Augmented-reality Preparation and Anxiety Before Pediatric Adenotonsillectomy in China: a Prospective Non-randomized Controlled Study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Tonsillectomy, Preoperative Care, Anxiety
- Being tested
- Screen-delivered augmented-reality group, Usual Care Group
- Keywords
- Anxiety, Augmented Reality, Child, Preoperative Care, Tonsillectomy, Clinical implications
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screen-delivered augmented-reality groupOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the time point immediately before induction of anesthesia (T2), assessed approximately 5 to 15 minutes after entry into the operating room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start4 Apr 2026
- Primary completion30 Jun 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Zhang, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760571
- Sponsor's protocol ID
- XiaoWang
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 32618627Chen 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.
PubMed 35672942Ooi 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.
PubMed 38303681Carbo 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.
PubMed 38916221Birckhead 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.
PubMed 30702436Bandyopadhyay 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.
PubMed 38666175Almuqad FA, Alsaedi GT, Alahmadi TA, Alalawi SI, Mulla RM, Almohammadi RM, Abulfaraj M. Effectiveness of Digital Storytelling and Immersive Technology Interventions in Reducing Preoperative Anxiety Among Children: Systematic Review and Meta-Analysis. JMIR Pediatr Parent. 2026 Aug 5;9:e92880. doi: 10.2196/92880.
PubMed 42053523
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screen-delivered Augmented-reality Preparation and Anxiety Before Pediatric Adenotonsillectomy in China: a Prospective Non-randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07760571
- Acronym / sponsor ID
- XiaoWang
- Conditions
- Tonsillectomy, Preoperative Care, Anxiety
- Keywords
- Anxiety, Augmented Reality, Child, Preoperative Care, Tonsillectomy, Clinical implications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 4 Apr 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Screen-delivered augmented-reality group | Experimental | Other: Screen-delivered augmented-reality groupOn 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. |
| Usual Care Group | Active comparator | Other: Usual Care GroupChildren 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. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screen-delivered augmented-reality groupBefore 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 | Screen-delivered augmented-reality group |
| Usual Care GroupParticipants 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. | Other | Usual Care Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Results publication: PubMed 32618627Jung 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.
- Results publication: PubMed 35672942Chen 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.
- Results publication: PubMed 38303681Ooi 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.
- Results publication: PubMed 38916221Carbo 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.
- Results publication: PubMed 30702436Birckhead 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.
- Results publication: PubMed 38666175Bandyopadhyay 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.
- Results publication: PubMed 42053523Almuqad FA, Alsaedi GT, Alahmadi TA, Alalawi SI, Mulla RM, Almohammadi RM, Abulfaraj M. Effectiveness of Digital Storytelling and Immersive Technology Interventions in Reducing Preoperative Anxiety Among Children: Systematic Review and Meta-Analysis. JMIR Pediatr Parent. 2026 Aug 5;9:e92880. doi: 10.2196/92880.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screen-delivered augmented-reality group in people with Tonsillectomy and Preoperative Care, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07760571, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.