Virtual Reality to Manage Pediatric Gastrointestinal Endoscope-related Anxiety, Post Procedural Pain, and Recovery Time: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in Children's Anxiety Levels
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of a virtual reality (VR) intervention in managing anxiety, post-procedural pain, and recovery time among pediatric patients undergoing gastrointestinal (GI) endoscopy. The study is conducted at the Pediatric Gastrointestinal Endoscopy Unit, Mansoura University Children's Hospital, Egypt. Eligible children are randomly assigned to either a VR intervention group or a control group receiving standard care. The VR group uses a head-mounted display featuring age-appropriate immersive applications before endoscopy. Measured outcomes include anxiety levels, physiological stability, post-procedural pain, and recovery duration. The study follows CONSORT guidelines and ethical principles outlined in the Declaration of Helsinki.
详细描述
This prospective randomized controlled experimental study investigates the use of virtual reality (VR) as a non-pharmacological nursing intervention to reduce anxiety and enhance recovery outcomes in pediatric patients undergoing gastrointestinal endoscopic procedures. The study is conducted at the Pediatric Gastrointestinal Endoscopy Unit of Mansoura University Children's Hospital, located in Mansoura City, Dakahlia Governorate, Egypt.
Participants include children aged 6-15 years scheduled for their first GI endoscopy who demonstrate an interest in technology and consent to participate. Children with seizure disorders, cardiac diseases, visual or hearing impairments, developmental delays, motion sickness, or those undergoing chemotherapy are excluded.
Following ethical approval and informed consent, participants are randomly allocated in a 1:1 ratio to either the VR intervention or control group. Both groups receive a standardized pre-procedural education session delivered by the endoscopist, anesthesiologist, and nurse. In the waiting area, baseline assessments include demographic characteristics, state and trait anxiety (using the State-Trait Anxiety Inventory for Children), physiological parameters (respiratory rate, heart rate, and oxygen saturation), and pain level (using the Wong-Baker FACES Pain Rating Scale).
Children in the VR group wear a head-mounted display containing preloaded age-appropriate immersive environments, such as virtual roller coasters, space exploration, wildlife parks, and travel scenes, for one minute before entering the endoscopy room. The nurse assists with headset adjustment and ensures proper device hygiene. The control group receives standard pre-procedural care without VR exposure.
Anxiety and physiological indicators are reassessed in the endoscopy room prior to anesthesia induction. Post-procedural pain and recovery duration (time spent in the recovery room until discharge) are recorded afterward. Data are analyzed using SPSS version 26, employing descriptive statistics, independent t-tests, chi-square tests, and non-parametric alternatives where appropriate. Statistical significance is set at p < .05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
This was a single-blind randomized controlled trial. Participants and clinical staff were aware of group allocation due to the visible nature of the VR intervention. However, the statistician analyzing the data was blinded to group assignments to minimize assessment bias.
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-15 years scheduled to undergo a gastrointestinal endoscopic procedure.
- •First-time endoscopy patients (no prior endoscopic experience).
- •Willing to participate, with informed consent from parents/guardians and child assent.
- •Interest in technology and ability to tolerate a brief VR experience.
- •- Physically and cognitively able to complete the anxiety and pain assessment tools (STAI-CH and FACES scales).
排除标准
- •Children with a known history of seizure disorders or cardiac diseases.
- •Presence of active infection, burns, or trauma involving the periorbital skin, eyes, nasal bridge, external ear, scalp, or hair.
- •Visual or hearing impairments that would interfere with VR use.
- •Developmental delays (including autism spectrum disorders) that significantly limit cooperation or understanding of instructions.
- •Active psychosis or symptoms of intoxication.
- •History of severe motion sickness.
- •Children currently undergoing chemotherapy.
结局指标
主要结局
Change in Children's Anxiety Levels
时间窗: Trait subscale was assessed only prior to the child's entry while the State subscale was assessed prior to entrance into the endoscopy room (pre-procedure) and before the induction of anesthesia (peri-procedure).
Anxiety levels was measured using the State-Trait Anxiety Inventory for Children (STAI-CH). Both the trait and state subscales was used. The primary outcome was the difference in state anxiety scores before and during the intervention between the VR and control groups. Each item is scored on a 3-point Likert scale, with total scores ranging from 20 to 60, where higher scores indicate greater anxiety.
Change in Pain Level
时间窗: Two time points: pre-procedural pain level (immediately before entering the endoscopy room) and post-procedural pain level (30 minutes post-procedure in the recovery unit).
pain will be measured using the Wong-Baker FACES Pain Rating Scale, which ranges from 0 (no pain) to 10 (worst pain). The outcome represents the mean difference in pain levels between the VR and control groups following the endoscopic procedure.
Recovery Duration
时间窗: Measured from the time of entry into the recovery room until discharge, assessed up to 300 minutes.
Recovery time will be measured as the total duration of each child's stay in the recovery room (recorded in minutes and presented in hours) from entry into the recovery unit until discharge criteria are met. The outcome represents the mean recovery duration between the VR and control groups.
次要结局
- Change in respiratory rate(Respiratory rate was assessed immediately before entering the endoscopy room (pre-procedure) and again prior to anesthesia induction (peri-procedure).)
- Change in heart rate(Heart rate was assessed prior to entrance into the endoscopy room (pre-procedure) and before the induction of anesthesia (peri-procedure).)
- Change in Oxygen Saturation(Oxygen saturation was assessed prior to entrance into the endoscopy room (pre-procedure) and before the induction of anesthesia (peri-procedure).)
研究者
Rasha Gad
Lecturer of pediatric Nursing
Mansoura University