Psychological Stress Clinical Trial
Official title:
A Nursing Intervention to Enhance Comfort and Promote Psychological Well-Being in Children During and Following PICU Hospitalization: A Pilot Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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