A Nursing Intervention to Enhance Child Comfort and Psychological Well-Being During and Following PICU Hospitalization
Condition: Psychological Stress
MeSH terms: Stress, Psychological
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Comfort Care; Usual care
Intervention type(s): Other; Other
Intervention description(s): The intervention will consist of two parts: (1) A 15-20 minute period of parental soothing at the bedside comprised of calming activities which the child and parents are familiar with; (2) A quiet period will follow, in which earmuffs are applied over the child's ears to block auditory stimulation. The intervention will take place twice/24 hours, up to a maximum of 72 hours. Total time of first (daytime) intervention will be 2 hours, and of second (night-time) intervention will be 7 hours.; Usual nursing care for the child in the Pediatric Intensive Care Unit, including usual parental involvement and usual exposure to unit noise levels.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pediatric Intensive Care Unit; Environmental Stressors; Sleep; Psychological Outcomes; Pediatrics