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临床试验/NCT06605339
NCT06605339已完成不适用

Virtual Reality on Pain, Fear and Emotional Experience During Port Needle Insertion in Pediatric Hematology and Oncology Patients

Dokuz Eylul University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Pain assesed by Wong-Baker FACES

研究概览

简要总结

In pediatric hematology-oncology patients, the need for a central venous catheter may arise in some cases to provide treatment. Totally implanted vascular access devices are known as "ports," and port catheters are commonly used due to their lower risk of infection. To maintain the port system and prevent infection, the port needle should be replaced every 5-7 days. During the course of treatment, pediatric hematology-oncology patients undergo frequently repeated procedures associated with high levels of pain and distress. Pain and distress resulting from repeated procedures are often uncomfortable symptoms for pediatric patients and their families. There are pharmacological and non-pharmacological methods to reduce pain and anxiety during port needle procedures in pediatric hematology-oncology patients. One pharmacological method, distraction, increases pain tolerance by focusing attention away from the painful stimulus. This technique is used as a powerful tool for pain and anxiety management in pediatric pain. Virtual reality glasses, used as a distraction method, provide access to an interactive, three-dimensional, computer-simulated environment through a head-mounted device that blocks out real-world views. It is stated that distraction with virtual reality is a beneficial non-pharmacological method for children during hospital-based needle applications for pediatric patients. This study evaluated the effect of virtual reality on pain, fear, and emotional appearance related to needle procedures in pediatric hematology-oncology patients during port needle changes.

详细描述

The study was conducted at the Pediatric Hematology and Oncology Clinic of Afyonkarahisar Health Sciences University Health Practice and Research Center.

Research Hypotheses:

H1: There is a difference in pain and fear scores among patients who watch videos using virtual reality glasses during port needle changes.

H2: There is a difference in emotional appearance scores among patients who watch videos using virtual reality glasses during port needle changes.

Randomization:

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 (Investigator)

入排标准

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

入选标准

  • The child having a port catheter in place.
  • The child agreeing to voluntarily participate in the study.
  • The parent agreeing to voluntarily participate in the study.
  • Obtaining consent forms from both the child and the parent.

排除标准

  • The child had a physical or psychological deficits that would prevent the child from wearing the headset needed to watch virtual reality

结局指标

主要结局

Pain assesed by Wong-Baker FACES

时间窗: after the port needle insertion

Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10

Fear assesed by Child Fear Scale

时间窗: after the port needle insertion

The Child Fear Scale (CFS), this one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear.

emotional apperance assesed by Emotional Appearance Scale for Children

时间窗: after the port needle insertion

This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5.

次要结局

未报告次要终点

研究者

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

Gülçin Özalp Gerçeker

Assoc. Prof.

Dokuz Eylul University

研究点 (2)

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