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临床试验/NCT01176188
NCT01176188已完成1 期

A Nursing Intervention to Enhance Comfort and Promote Psychological Well-Being in Children During and Following PICU Hospitalization: A Pilot Study

McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年8月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Acceptability and feasibility of the comfort intervention

研究概览

简要总结

Children who become critically ill and require Pediatric Intensive Care Unit (PICU)hospitalization may develop negative psychological outcomes following discharge. This pilot study will test a nursing intervention that seeks to promote child comfort, sleep and psychological well-being during and following PICU hospitalization.

Study objectives are to:

  1. test the feasibility and acceptability of a PICU comfort care intervention that can be administered by nursing staff
  2. examine the feasibility and acceptability of data collection procedures
  3. pilot test outcome measures
  4. determine effect sizes to inform sample size calculation for a future multi-centred randomized controlled trial (RCT).

The intervention will take place in the PICU, and consists of a parental soothing activity followed by a quiet period in which earmuffs are placed over the child's ears to block noise. Children's sleep time and comfort level will be monitored in the PICU, and the investigators will follow them for 3 months post-discharge to examine the effects of the intervention on psychological well-being.

详细描述

Background: Children who become critically ill and require Pediatric Intensive Care Unit (PICU) hospitalization may develop negative psychological outcomes following discharge. Despite this concern, there have been no systematic attempts to intervene with critically ill children to promote well-being, and prevent long term sequelae. The aim of this pilot study is to test the feasibility and acceptability of a PICU nursing intervention that seeks to enhance child comfort and promote sleep quality and duration in the PICU, potentially promoting psychological well-being post-discharge. The intervention is based on principles of Developmental Care, a philosophy of care that includes the child and family, and incorporates intervention strategies to reduce environmental stressors and improve quality of life. In view of the critically ill child's state of physical and emotional vulnerability, and the highly noxious environmental stimuli they are exposed to in the PICU, our proposed intervention has the potential to enhance physiological and psychological stability in this population. We will examine intervention effects on children's quality of sleep and sleep duration in the PICU, psychological distress post-PICU, and on parent anxiety during and following their child's PICU hospitalization.

Objectives: (1) To test the feasibility and acceptability of a PICU comfort care intervention that can be administered by nursing staff; (2) to examine the feasibility and acceptability of data collection procedures; (3) to pilot test outcome measures; and (4) to determine effect sizes to inform sample size calculation for a future multi-centred randomized controlled trial (RCT).

Design: A pilot study will be conducted using RCT design.

Outcomes: Results of this pilot study will provide essential information regarding feasibility of recruitment and randomization, as well as feasibility and acceptability of the developmental care intervention and data collection procedures - all of which will be incorporated into a full-scale RCT. While sample size is insufficient to allow statistical analyses, we will obtain initial estimates regarding changes in sleep duration, sleep fragmentation, and psychological well-being post-intervention.

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

  • Child aged 6-17 admitted to the PICU of one Canadian, university teaching hospital
  • Child in age-appropriate grade at school (+- 1 year)
  • Child can read and speak English or French
  • Parent or primary caregiver willing to participate in the intervention, who can read, speak and write English or French

排除标准

  • Child diagnosed with a sleep disorder, seizure disorder, hearing disorder, or who has had neurological surgery that precludes sleep measurement
  • Child expected to die during their PICU stay

结局指标

主要结局

Acceptability and feasibility of the comfort intervention

时间窗: Time 1: Pediatric Intensive Care Unit, post-intervention: Time 2: Hospital Ward; Time 3: 3 months post-discharge

次要结局

  • Child Anxiety(3 months post-discharge)
  • Child Sleep(Time 1: During Pediatric Intensive Care Unit stay; Time 2: Hospital Ward; Time 3: 3 months post-discharge)
  • Child Distress(3 months post-Pediatric Intensive Care Unit discharge)
  • Parent Anxiety(Time 1: During child's Pediatric Intensive Care Unit stay; Time 2: 3 months post-discharge of child)
  • Child Comfort(During Pediatric Intensive Care Unit stay)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Janet Rennick

Nurse Scientist

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (2)

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