跳至主要内容
临床试验/NCT04413773
NCT04413773已完成不适用

Use of Simple Explanation Videos to Reduce Perioperative Patient Anxiety in Children.

Universitätsklinikum Hamburg-Eppendorf4 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2019年9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
94
试验地点
4
主要终点
Change in perioperative Anxiety in Children (T1 vs. T2, TAU vs. Video)

研究概览

简要总结

The reduction of preoperative anxiety in children and adolescents before an elective surgical procedure is an important clinical question in perioperative care. Adequate, age-appropriate patient information about the processes of the inpatient stay plays an important role in order to address possible worries and fears to reduce.

The medium video is popular with children and adolescents today and offers the possibility of an easily understandable and vivid presentation of information.

详细描述

Studies by the health insurance companies, scientific publications and economic papers show that in times of increasing economic interests of the hospitals and the resulting necessity of economic working methods in the medical system, less time remains for human interaction. This creates areas of conflict, such as the patient's right to information regarding the time available to medical personnel. This in turn leads to significant stress factors in patients who are involved in the treatment and mostly on the communication level, such as "Missing information", "misunderstood visit", "missing partnership relationship" refer to what is reflected in patient satisfaction and fears. Studies show how important good perioperative psychosocial care is for reducing these circumstances in children, also and especially in the context of further development. The drug options for calming and reducing anxiety are already known, but there are also increasing numbers of non-drug approaches to reducing anxiety and stress in the literature. Painting therapy and clinic clowns are examples. However, access to such resources is limited and costs are permanently high. New technologies, e.g. mobile phones and tablets, with the associated media, increasingly finding their way into our society, are now inexpensive to buy and have become an integral part of most households. Such devices and media are increasingly used in clinical studies and patient care. Their use is tested extensively in modern medicine, e.g. to avoid unnecessary postoperative consultations in the emergency room or to increase cognitive learning for children. Even small children can use and understand these media early on. Videos are one of the most common media already understood by the smallest patients.

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
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All patients (children) who present themselves planned in the Altona Children's Hospital or in the University Clinic Hamburg Eppendorf in the course of an upcoming elective operation.
  • The surgical intervention must take place in one of the following body regions: thorax, abdomen and / or extremities (incl. Head and neck)
  • A signed declaration of consent from the parents or legal guardians is available
  • The patient has given a declaration of consent
  • No mental illnesses may be diagnosed
  • No chronic pre-existing conditions may be diagnosed
  • Age of the patients is between 6 and 17 years

排除标准

  • No signed declaration of consent from the parents or legal guardians available
  • There is no signed declaration of consent from the patient

结局指标

主要结局

Change in perioperative Anxiety in Children (T1 vs. T2, TAU vs. Video)

时间窗: Through study completion, an average of 1 year

The primary endpoint was to analyze the preoperative state-anxiety in children before (t1) and after (t2) the intervention (video), compared with standard care (TAU). we use State-Trait-Anxiety-Operation-Inventory

次要结局

  • Nurse reported anxiety before and after Intervention (T1 vs. T2)(Through study completion, an average of 1 year)
  • Perioperative Anxiety separated in state and trait anxiety (T1 vs T2, TAU vs Video)(Through study completion, an average of 1 year)
  • Evaluation of STOA in a pediatric cohort(Through study completion, an average of 1 year)
  • Change in perioperative Anxiety in Parental Report (T1 vs. T2, TAU vs. Video)(Through study completion, an average of 1 year)

研究者

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

Dr. med. Julian Trah

Medical Doctor

Universitätsklinikum Hamburg-Eppendorf

研究点 (4)

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