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This pilot randomized controlled trial will evaluate whether a virtual reality (VR) preparation program can improve the perioperative experience of children aged 3 to 12 years undergoing elective surgery. Children scheduled for surgery at HM Hospital in Madrid, Spain, will be randomly assigned to receive either a VR-based educational experience (NixiKit) or the standard preoperative preparation routinely provided by nursing staff.
The VR intervention includes an immersive virtual tour of the preoperative area, operating room, and recovery room, designed to familiarize children with the surgical process in an age-appropriate manner. The control group will receive the usual verbal explanation and support provided by nurses before surgery.
The study will assess children's fear, preoperative anxiety, cooperation during anesthesia induction, and postoperative pain. Parents' experience and satisfaction with care will also be evaluated. The results of this pilot study will help determine the feasibility and potential effectiveness of VR as a nursing-led preparation strategy for pediatric surgical patients.
Preoperative anxiety and fear are common among children undergoing elective surgery and may negatively affect cooperation during anesthesia induction, perioperative experience, and postoperative recovery. Educational preparation programs have been developed to help children and their families better understand the surgical process; however, conventional preparation methods may not fully address the emotional needs of pediatric patients.
Virtual reality (VR) has emerged as a promising tool for perioperative preparation by providing immersive and interactive experiences that allow children to become familiar with the hospital environment before surgery. Previous randomized studies and recent systematic reviews have suggested that VR-based preparation may reduce preoperative anxiety and fear while improving cooperation during anesthesia induction and family satisfaction. Nevertheless, evidence remains limited regarding its effectiveness when compared with structured nurse-led preparation delivered as part of routine clinical practice, particularly in real-world hospital settings.
This pilot study aims to evaluate the feasibility and potential effectiveness of a VR-based preoperative preparation program for pediatric patients undergoing elective surgery. The intervention uses the NixiKit system, which provides an immersive virtual tour of the perioperative journey, including the preoperative area, operating room, and recovery room, through age-appropriate audiovisual content designed to familiarize children with the surgical environment.
Participants assigned to the intervention group will receive the VR experience during hospital admission before surgery. Participants assigned to the comparison group will receive the standard preoperative preparation routinely delivered by nursing staff. Data collected during the perioperative period will be used to explore the impact of the intervention on psychological and behavioral outcomes in children as well as on family experience.
As a pilot randomized controlled trial, this study is intended to provide preliminary estimates of intervention effects, assess study procedures and feasibility, and generate information to support the design of a future definitive multicenter trial evaluating virtual reality as a perioperative preparation strategy in pediatric surgical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Preparation | Experimental | Participants assigned to this arm will receive a virtual reality-based preoperative preparation program using the NixiKit system before elective surgery. The intervention consists of an immersive 360-degree virtual tour of the perioperative pathway, including the preoperative area, operating room, and recovery room, delivered through a virtual reality headset connected to amobile phone. The experience is designed to familiarize children with the surgical environment, reduce fear and anxiety, and improve preparedness for surgery. Participants will also receive routine perioperative care provided by the hospital. |
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| Standard Nursing Preparation | Active Comparator | Participants assigned to this arm will receive the standard preoperative preparation routinely provided by nursing staff before elective surgery. This preparation includes a verbal explanation of the perioperative process, including admission procedures, transfer to the preoperative area, anesthesia induction, the operating room environment, and postoperative recovery. Children and their parents will have the opportunity to ask questions and receive clarification regarding the surgical procedure. Participants will receive routine perioperative care according to hospital practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NixiKit Virtual Reality Preparation | Device | Participants assigned to the intervention group will receive a virtual reality-based preoperative preparation program using the NixiKit system (Nixi for Children). The intervention consists of an immersive 360-degree virtual tour delivered through a pediatric virtual reality headset connected to a smartphone. The experience guides children through the perioperative journey, including the preoperative area, operating room, and recovery room, using age-appropriate narration and storytelling designed to familiarize them with the surgical environment and procedures. The virtual experience lasts approximately 10 to 15 minutes and is delivered during hospital admission before elective surgery. In addition to the virtual reality experience, participants receive the standard components of the NixiKit package, including educational and supportive materials intended to reinforce preparation for surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Preoperative Anxiety | Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS), an observational instrument widely used in pediatric surgical populations. The scale evaluates activity, vocalization, emotional expressivity, apparent arousal, and interaction with parents. Total scores range from 23.3 to 100, with higher scores indicating greater anxiety. The primary outcome will be the change in mYPAS score between baseline assessment and post-intervention assessment. | From baseline (T0, immediately before intervention) to immediately after intervention (T1, approximately 15-45 minutes after baseline). Same day, prior to surgery |
| Change in Fear Level | Measured using the Children's Fear Scale (CFS). Scores range from 0 to 4, with higher scores indicating greater fear. The outcome will be the change in fear score from baseline to immediately after the intervention. | From baseline (T0, immediately before intervention) to immediately after intervention (T1, approximately 15-45 minutes after baseline). Same day, prior to surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cooperation During Anesthesia Induction | Cooperation during anesthesia induction will be assessed using the Induction Compliance Checklist (ICC). The checklist includes 10 observational items scored as 0 or 1, with higher scores indicating more negative behaviors and poorer cooperation during induction. | During anesthesia induction, after transfer to the operating room on the day of surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cayetana Ruiz Zaldibar, Dr | Contact | 695829472 | crzaldibar@ucjc.edu |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36700361 | Result | Franco Castanys T, Jimenez Carrion A, Rodenas Gomez F, Clemente Garcia S, Melero Mascaray A, Janeiro Amela M, Busquets Bonet J. Effects of virtual tour on perioperative pediatric anxiety. Paediatr Anaesth. 2023 May;33(5):377-386. doi: 10.1111/pan.14639. Epub 2023 Feb 7. | |
| 25010821 | Result | Jenkins BN, Fortier MA, Kaplan SH, Mayes LC, Kain ZN. Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg. 2014 Sep;119(3):643-650. doi: 10.1213/ANE.0000000000000350. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Participants will be randomly assigned in a 1:1 ratio to one of two parallel study arms. The intervention arm will receive a virtual reality-based preoperative preparation program (NixiKit) in addition to routine perioperative care, while the control arm will receive the standard preoperative preparation routinely provided by nursing staff. Participants will remain in their assigned group throughout the study, and outcomes will be assessed at predefined perioperative time points.
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Due to the nature of the intervention, participants and nursing staff delivering the intervention cannot be blinded to group allocation. However, the data analysts responsible for statistical analyses will remain blinded to treatment allocation throughout the study. In addition, the anesthesia nurse assessing induction compliance will not be informed of participant group assignment.
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| Standard Nursing Preoperative Preparation | Behavioral | Participants assigned to the control group will receive the standard preoperative preparation routinely provided by nursing staff. This preparation includes a verbal explanation of the perioperative process, including transfer to the preoperative area, operating room procedures, anesthesia induction, and postoperative recovery, as well as the opportunity for children and their parents to ask questions and receive clarification about the surgical process. |
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| Postoperative Pain | Pain will be assessed using the Wong-Baker FACES Pain Rating Scale. Scores range from 0 to 10, with higher scores indicating greater pain intensity. | Day of surgery, after return to the hospital room |
| Parent Experience and Satisfaction | Parent experience and satisfaction will be assessed using the EMCA Pediatric Hospitalization Questionnaire, a parent-reported measure of pediatric inpatient experience. The questionnaire includes multiple items evaluating information provided, communication with healthcare professionals, participation in care, hospital environment, and overall quality of care. Individual questionnaire items will be analyzed according to their response categories, with more favorable responses indicating a more positive care experience. | At hospital discharge, up to 72 hours after surgery |
| 21806301 | Result | McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1. |