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临床试验/NCT04976114
NCT04976114已完成不适用

Reducing Preoperative Anxiety in Parents of Surgical Patients

Hospital San Carlos, Madrid0 个研究点目标入组 140 人开始时间: 2016年10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
140
主要终点
Anxiety level

研究概览

简要总结

Aims and objectives: To investigate preoperative anxiety in parents of paediatric surgical patients, testing whether the provision of information (using video and story books) regarding the surgical process can impact on reducing anxiety. Analyse if some personal factors influence the reduction of anxiety.

Background: Attending a surgical theatre generates anxiety in all types of patients, especially in the case of children. The effect of different preoperative intervention procedures in children that attempt to reduce their anxiety level have been studied a great deal. However, although their parents also suffer high anxiety levels, potential intervention to reduce their levels have not received the same attention.

Study design: Randomised Clinical trial Methods: One hundred and twenty-five parents of children (8-12 y.o.) undergoing surgery in Hospital Universitario Central de Asturias hospital (Oviedo, Spain) were randomly assigned to the control group (34 individuals) or one of the 3 experimental groups (91). After the pre-anaesthesia consultation, children and parents of the experimental groups were provided with a story book, a video with additional information of nursing, or both. In the antechamber of the operating room and prior to the surgical intervention, the State Anxiety and Trait Anxiety of the parents and children were measured using the STAI and STAIC questionnaires respectively. The data collection, including different demographic variables was carried out for 12 months starting in October 2016

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

As it is not possible for the participants to be blinded, they were asked not to mention to the assessment researchers (or other parents they could meet) what was the information they received, ensuring the researchers to remain blinded.

入排标准

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

入选标准

  • Undergoing surgery at Asturias Central Hospital

排除标准

  • Children not in the age range,
  • Emergency surgery,
  • Children not able to understand or read
  • Parents not present or refused to participate.

结局指标

主要结局

Anxiety level

时间窗: Presurgery, just the moment before to surgery

Level of presurgery anxiety measured by State-Trait Anxiety Inventory scale

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

Emilio Vargas Castrillón

Head of clinical pharmacoloy hospital clinico san carlos

Hospital San Carlos, Madrid

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