Preoperative Virtual Reality Intervention to Improve the Perioperative Experience in Children Undergoing Elective Surgery: A Pilot Randomized Controlled Trial
| Registry | NCT07650695 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 56 (Estimated) |
| Sponsor | Fundación de investigación HM (Other) |
| Conditions | Preoperative Anxiety, Fear, Pediatric Surgery, Preoperative Care |
| Interventions | NixiKit Virtual Reality Preparation, Standard Nursing Preoperative Preparation (Device, behavioral) |
| Dates | start 2026-09-09, primary completion 2027-01-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-06-16, last updated 2026-09-28 |
| Locations | 1 site in Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Preoperative Anxiety All trials for Fear All trials of NixiKit Virtual Reality Preparation All trials of Standard Nursing Preoperative Preparation
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Virtual Reality Preparation | Experimental | Device: NixiKit Virtual Reality Preparation | 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. |
| Standard Nursing Preparation | Active comparator | Behavioral: Standard Nursing Preoperative 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. |
Sex: All, ages: 3 Years to 12 Years
Inclusion Criteria: * Children aged 3 to 12 years. * Scheduled for elective surgery under anesthesia. * Parent or legal guardian owns a mobile phone. * Ability to understand simple instructions, according to clinical judgment and developmental level. * Sufficient Spanish language proficiency of the child and at least one parent or legal guardian. * Written informed consent from parents or legal guardians and child assent when applicable. Exclusion Criteria: * Emergency or urgent surgery. * Moderate to severe neurodevelopmental disorder or intellectual disability limiting understanding of the intervention or study scales. * Severe visual or hearing impairment preventing use of virtual reality. * History of photosensitive epilepsy, severe vertigo, severe motion sickness, or other conditions that could worsen with virtual reality. * Severe decompensated psychiatric disorder. * Use of intense sedative premedication before baseline assessment that prevents evaluation of preoperative anxiety.
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital HM Puerta del Sur | Madrid, Mujer | Spain | Recruiting |