跳至主要内容
临床试验/NCT07276893
NCT07276893已完成不适用

Preparation of the Pediatric Patient Before Cardiac Catheterization: A Randomized Controlled Trial

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Child Anxiety Scale

研究概览

简要总结

This study aimed to determine the effect of an animated film shown through virtual reality (VR) glasses before cardiac catheterization on children's pre-procedure anxiety and fear levels and post-procedure pain. H1: Animated films viewed through virtual reality glasses reduce procedure-related anxiety in children.

H2: Animated films viewed through virtual reality glasses reduce procedure-related fear in children.

H3: Animated films viewed through virtual reality glasses reduce procedure-related pain in children.

Prior to the cardiac catheterization procedure, the researcher administered the Individual Assessment Form and the Children's Fear Scale to the children and had them complete the Children's Anxiety Scale-State Scale. One hour before the procedure, the children were shown the animated film "Super Heart Team: Ready for Action" using virtual reality glasses. After the animated film was shown to the child, the Child Anxiety Scale-State (CAS-D) was administered, and the Child Fear Scale was assessed by the researcher. Thirty minutes after the cardiac catheterization procedure was completed and the child returned to the children's ward, the researcher evaluated the Child Fear Scale and Wong Baker Facial Pain Scale and had the child complete the Child Anxiety Scale-State (CAS-D). Additionally, heart rate, respiratory rate, and O2 saturation were recorded at 15, 30, and 60 min after the procedure.

详细描述

Healthcare professionals have developed preoperative preparation programs that include methods such as short films, videos, picture books, play activities, and surgical room tours to help children cope with surgical procedures and reduce negative reactions. These methods are low-cost, minimally invasive, have a minimal risk of adverse effects, and are continuously and widely applicable to various diseases. Studies indicate that animated videos used to distract children's attention before surgery reduce preoperative anxiety (Özyılmaz et al., 2024; Yang et al., 2022) and increase compliance during surgery (Yang et al., 2022).

This study aimed to determine the effect of an animated film shown through virtual reality (VR) glasses before cardiac catheterization on children's pre-procedure anxiety and fear levels and post-procedure pain. H1: Animated films viewed through virtual reality glasses reduce procedure-related anxiety in children.

H2: Animated films viewed through virtual reality glasses reduce procedure-related fear in children.

H3: Animated films viewed through virtual reality glasses reduce procedure-related pain in children.

Prior to the cardiac catheterization procedure, the researcher administered the Individual Assessment Form and the Children's Fear Scale to the children and had them complete the Children's Anxiety Scale-State Scale. One hour before the procedure, the children were shown the animated film "Super Heart Team: Ready for Action" using virtual reality glasses. After the animated film was shown to the child, the Child Anxiety Scale-State (CAS-D) was administered, and the Child Fear Scale was assessed by the researcher. Thirty minutes after the cardiac catheterization procedure was completed and the child returned to the children's ward, the researcher evaluated the Child Fear Scale and Wong Baker Facial Pain Scale and had the child complete the Child Anxiety Scale-State.

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 (Participant)

盲法说明

Only participants were masked

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Being a child patient aged 5-10 years old hospitalized in the Cardiology Clinic of Ege University Hospital (Health Application and Research Center) Children's
  • Hospital and scheduled for cardiac catheterization,
  • The child being able to read and write,
  • Having developed language skills/no communication problems,
  • The family agreed to participate in the study,
  • The child volunteered to participate in the study,

排除标准

  • Having vision problems or wearing glasses,
  • Having a psychological diagnosis,
  • Not being able to understand or speak Turkish,
  • The child did not want to complete the scales after the procedure,
  • The child or parent wanting to withdraw from the study,
  • Not agreeing to participate in the study.

结局指标

主要结局

Child Anxiety Scale

时间窗: One hour before the procedure, 30 minutes after the procedure

Animated films viewed through virtual reality glasses reduce procedure-related anxiety in children.

Child Fear Scale

时间窗: one hour before the procedure, 30 minutes after the procedure

Animated films viewed through virtual reality glasses reduce procedure-related fear in children.

Wong Baker Facial Pain Scale

时间窗: Thirty minutes after the procedure

Animated films viewed through virtual reality glasses reduce procedure-related pain in children.

次要结局

未报告次要终点

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hatice Uzşen

Principal investigator

Ondokuz Mayıs University

研究点 (1)

Loading locations...

相似试验