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临床试验/NCT06675877
NCT06675877招募中不适用

Impact of Virtual Reality on Pain, Anxiety and Depression in Pediatric Patients with ESRD on Regular Hemodialysis Through Arteriovenous Fistula.

Tanta University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
SCARED for anxiety Screen for Child Anxiety Disoders {SCARED} Child, parent version: It is a self-report screening questionnaire for anxiety disorders during hemodialysis

研究概览

简要总结

This case control study will be conducted to study the effectiveness of Virtual Reality technique on pain during arteriovenous cannulation and on reduction of anxiety and depression in Pediatric Patients with ESRD undergoing regular hemodialysis through arteriovenous fistula.

详细描述

This case control study will be conducted at nephrology and dialysis Unit Pediatric Department Tanta University Hospital (TUH) for a period of 6 months starting from April 2024.This study will be conducted on convenient sample of 60 participants. they will be classified as follow group A (cases) Group B (controls)each group will contain 30 children and adolescents with end stage renal disease on regular hemodialysis for three times weekly at our nephrology Unit at TUH during the period of the study

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients with end stage renal disease aged from 8 to 18 years on regular hemodialysis through functioning arteriovenous fistula and are fully oriented with time, persons and place at time of data collection. All participants either cases or controls suffer from anxiety, depression or both.

排除标准

  • Children with temporary or permanent catheter for dialysis.
  • Children with mental illness, visual and auditory defects.
  • Children took any pharmacological pain reliever or antipsychotic drugs.
  • Non anxious or depressed Children.

结局指标

主要结局

SCARED for anxiety Screen for Child Anxiety Disoders {SCARED} Child, parent version: It is a self-report screening questionnaire for anxiety disorders during hemodialysis

时间窗: 6 months

The SCARED is useful for generalized anxiety disorder, social anxiety disorder, phobic disorders, and potentially school anxiety problems. Cases and controls will be asked to complete the questionnaire before entering the study (examination No. I) and after its completion after 3 months (examination No. II).

次要结局

  • The Children's Depression Inventory scale for depression during hemodialysis(6 months)

研究者

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

Sara Mabrouk Elghoul

lecturer of pediatrics

Tanta University

研究点 (2)

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