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临床试验/NCT07415343
NCT07415343已完成不适用

Impact of Virtual Reality on Fear and Pain in Pediatric Patients Undergoing Preoperative Preparation: A Randomized Controlled Study

Ege University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
1
主要终点
Preoperative Fear measured by the Children's Fear Scale (CFS)

研究概览

简要总结

Preoperative fear and postoperative pain are common problems in children undergoing surgery and may adversely affect perioperative outcomes. Nonpharmacological, child-centered interventions that support emotional preparation are increasingly emphasized in pediatric nursing care. :To investigate the effects of virtual reality on preoperative fear and postoperative pain in children aged 5-12 years undergoing surgery.This randomized controlled study was conducted in accordance with the CONSORT guidelines. A total of 74 children were randomly assigned using block randomization to either the Educational Animation (VR) group (n = 36) or the control group (n = 38). Data were collected using an information form, the Children's Fear Scale, and the Wong-Baker Faces Pain Rating Scale. Preoperative fear was assessed by child, nurse, and researcher ratings, while postoperative pain was evaluated at two time points by parents, nurses, and the researcher. No significant differences were found between the VR and control groups in preoperative fear scores based on child, nurse, or researcher assessments (p > .05). However, within the VR group, preoperative fear scores significantly decreased after the intervention across all evaluators (p < .001). Postoperative pain scores were significantly lower in the VR group compared with the control group at both postoperative assessments according to parent, nurse, and researcher ratings (p < .05 for all). VR-based educational interventions appear to be an effective and feasible, nurse-led nonpharmacological approach for reducing preoperative fear and postoperative pain in pediatric surgical patients. Integrating VR into routine preoperative nursing care may enhance children's perioperative experiences and support child-centered care practices.

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
None

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • child and parent provided informed consent,
  • the child was aged 5-12 years,
  • scheduled to undergo surgery for the first time

排除标准

  • they had any chronic medical illness,
  • exhibited cognitive impairment or mental retardation,
  • had previously undergone any surgical intervention,
  • were scheduled for a complex surgical procedure

研究组 & 干预措施

VR Group

Experimental

Children in the intervention group watched a preoperative preparation video via a Virtual Reality (VR) headset

干预措施: virtual reality (Other)

Control Group

No Intervention

Children in the control group received routine preoperative preparation according to the clinic protocol, without any additional intervention.

结局指标

主要结局

Preoperative Fear measured by the Children's Fear Scale (CFS)

时间窗: Preoperative period (immediately before surgery)

The Children's Fear Scale is a validated self-report tool consisting of five facial expressions representing increasing levels of fear. Scores range from 0 to 4, with higher scores indicating greater fear.

次要结局

  • Postoperative Pain measured by the Wong-Baker FACES Pain Rating Scale (WBFPRS)(Postoperative 1st hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Gümüş

Assistant Professor

Ege University

研究点 (1)

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