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临床试验/NCT05675358
NCT05675358已完成不适用

Virtual Reality on Pain, Fear, and Emotional Appearance During Phlebotomy in Pediatric Hematology and Oncology Patients

Dokuz Eylul University2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2022年3月3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
69
试验地点
2
主要终点
Pain assesed by Wong-Baker FACES

研究概览

简要总结

In this study, the effect of virtual reality, which is one of the pain relief methods, on the pain, fear and emotional appearance associated with the procedure, was evaluated in children aged 4-12 years who will undergo phelobotomy in a Pediatric Hematology and Oncology outpatient clinic.

详细描述

This prospective randomized controlled study was conducted in the pediatric hematology and oncology polyclinic blood collection unit of a university hospital in Turkey.

Patients undergoing phelobotomy were allocated to virtual reality or control groups according to a stratified randomization scheme.

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

The child's pain and fear were evaluated blindly to each other by the parent and the nurse who performed the phelobotomy attempt.

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 age range is between 4-12
  • to apply to the pediatric hematology and oncology outpatient clinic and to have blood taken
  • consent of the child and parent to voluntarily participate in the study
  • The child does not have a physical or psychological deficit that would prevent them from wearing glasses to watch virtual reality.

排除标准

  • having a fever (>37.5C) and severe dehydration
  • Before the invasive procedure, the patient was given anagesics.

结局指标

主要结局

Pain assesed by Wong-Baker FACES

时间窗: procedure - during the phelobotomy

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: procedure -during the phelobotomy

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.

Anxiety assesed by Children Anxiety Meter-State

时间窗: procedure- during the phelobotomy

The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10).

次要结局

  • emotional apperance assesed by Emotional Appearance Scale for Children(Baseline - before the phelobotomy)

研究者

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

Gülçin Özalp Gerçeker

pHD, Assoc. Prof.

Dokuz Eylul University

研究点 (2)

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