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A Nursing Intervention to Enhance Child Comfort and Psychological Well-Being During and Following PICU Hospitalization

NCT01176188 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-09-25

No results posted yet for this study

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.

Conditions

  • Psychological Stress

Interventions

OTHER

Comfort Care

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.

OTHER

Usual care

Usual nursing care for the child in the Pediatric Intensive Care Unit, including usual parental involvement and usual exposure to unit noise levels.

Sponsors & Collaborators

  • Réseau de recherche portant sur les interventions en sciences infirmières du Québec (RRISIQ)

    collaborator UNKNOWN

  • Canadian Nurses Foundation (CNF)

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Janet E Rennick, MSN, PhD · Montreal Children's Hospital, McGill University Health Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-12-31
Completion
2013-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01176188 on ClinicalTrials.gov