An interventional study of NixiKit Virtual Reality Preparation and Standard Nursing Preoperative Preparation in Preoperative Anxiety, Fear and Pediatric Surgery, sponsored by Fundación de investigación HM. Recruiting at 1 site in Spain. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Fundación de investigación HM · Not applicable, Interventional, and Treatment
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.
This study's planned enrollment of 56 is below the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Fundación de investigación HM is the lead sponsor of 22 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: NixiKit Virtual Reality Preparation
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.
Behavioral: Standard Nursing Preoperative Preparation
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.
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.
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.
Time frame: 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.
Time frame: From baseline (T0, immediately before intervention) to immediately after intervention (T1, approximately 15-45 minutes after baseline). Same day, prior to surgery
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.
Time frame: During anesthesia induction, after transfer to the operating room on the day of surgery.
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.
Time frame: 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.
Time frame: At hospital discharge, up to 72 hours after surgery
Plan to share: No
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Fundación de investigación HM