Preoperative Virtual Reality Intervention to Improve the Perioperative Experience in Children Undergoing Elective Surgery: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 主要终点
- Change in Preoperative Anxiety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: NixiKit Virtual Reality Preparation (Device)
Standard Nursing 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.
干预措施: Standard Nursing Preoperative Preparation (Behavioral)
结局指标
主要结局
Change in Preoperative Anxiety
时间窗: From baseline (T0, immediately before intervention) to immediately after intervention (T1, approximately 15-45 minutes after baseline). Same day, prior to surgery
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.
Change in Fear Level
时间窗: From baseline (T0, immediately before intervention) to immediately after intervention (T1, approximately 15-45 minutes after baseline). Same day, prior to surgery
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.
次要结局
- Cooperation During Anesthesia Induction(During anesthesia induction, after transfer to the operating room on the day of surgery.)
- Postoperative Pain(Day of surgery, after return to the hospital room)
- Parent Experience and Satisfaction(At hospital discharge, up to 72 hours after surgery)