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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
The study was a prospective, single‐center, outcome‐assessor‐blinded, non‐randomizedcontrolled study.Researchers recruited subjects from one Central SouthUniversity‐affiliated general tertiary hospital in Changsha, Hunan province, China. Andthe whole trail was on the basis of the CONSORT statements.Study procedures were approvedby the institutional review boards of all participating centers before data collectionbegan. All patients were screened by researchers for eligibility and then enrolled in thestudy if eligible and if the provided consent.The scheduled surgery date determined group assignment. Children scheduled on dates withodd day numbers received the intervention, and those scheduled on dates with even daynumbers received usual care alone. Allocation was predictable, was not concealed, andassigned every child treated on a given date to the same group.Children were eligible if they were aged 3‐12 years, scheduled for electiveadenotonsillectomy, and classified as American Society of Anesthesiologists physicalstatus I or II. The study excluded emergency or concomitant procedures, preinductionsedative or analgesic medication, and documented neurodevelopmental, psychiatric, orcognitive conditions that could affect participation or behavioral assessment.A researchteam member explained the study and confirmed that withdrawal would not affect clinicalcare. A parent or legal guardian provided written informed consent.A multidisciplinary team of pediatric, anesthesia, and nursing staff developed theintervention 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 sequencefollowed the child's pathway through surgical‐suite entry, preparation, transfer, theperiod before induction, post anesthesia recovery, and return to the ward.In the control group,an operating‐room nurse conducted the standard preoperative visit onthe day before surgery and provided psychological support. On the day of surgery,children arrived in a dedicated waiting room about 30 min before transfer. Venipunctureoccurred there while one parent remained present.The room contained cartoon wall decorations and age‐appropriate toys. During the30‐40‐min wait, a study nurse offered reassurance, provided perioperative guidance, andanswered questions. The accompanying parent left before anesthesia induction.In addition to usual care, intervention‐group children watched the augmented‐realityanimation on the same mobile television (Xiaomi L43RA‐RA) for 30‐40 min. Sound was keptwithin 35‐80 dB and adjusted in response to the child. A study nurse delivered andmonitored the intervention.Two trained nursing students who did not deliver the intervention completed outcomeassessments. 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). Inductioncooperation was assessed at T2.Training covered the purpose and scoring of each instrument and included standardizedpractice examples. It continued until interrater agreement reached a kappa of at least.80.The primary outcome was preoperative anxiety measured with the Modified Yale PreoperativeAnxiety Scale‐Short Form (mYPAS‐SF). Secondary outcomes were induction cooperation, heartrate, and blood pressure.
Epistemonikos ID: c6979fc300f84ec5fa25de370363b81eac04a4b6
First added on: Aug 12, 2026