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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Groupe de recherche interuniversitaire en interventions en sciences infirmières du Québec (GRIISIQ)
Canadian Nurses Foundation (CNF)
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01176188
First received: August 4, 2010
Last updated: August 18, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Psychological Stress
Other: Comfort Care
Other: Usual care
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Nursing Intervention to Enhance Comfort and Promote Psychological Well-Being in Children During and Following PICU Hospitalization: A Pilot Study

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Acceptability and feasibility of the comfort intervention [ Time Frame: Time 1: Pediatric Intensive Care Unit, post-intervention: Time 2: Hospital Ward; Time 3: 3 months post-discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Child Distress [ Time Frame: 3 months post-Pediatric Intensive Care Unit discharge ] [ Designated as safety issue: No ]
  • Child Comfort [ Time Frame: During Pediatric Intensive Care Unit stay ] [ Designated as safety issue: No ]
  • Parent Anxiety [ Time Frame: Time 1: During child's Pediatric Intensive Care Unit stay; Time 2: 3 months post-discharge of child ] [ Designated as safety issue: No ]
  • Child Anxiety [ Time Frame: 3 months post-discharge ] [ Designated as safety issue: No ]
  • Child Sleep [ Time Frame: Time 1: During Pediatric Intensive Care Unit stay; Time 2: Hospital Ward; Time 3: 3 months post-discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Comfort Care
Parental soothing, including tactile and auditory strategies, followed by a quiet period with the application of earmuffs to block auditory stimulation
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 Name: Comfort Care
Active Comparator: Usual Care 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.
Other Name: Usual care

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176188

Contacts
Contact: Diane Laforte, BA, CCRC 514-412-4400 ext 22521 diane.laforte@muhc.mcgill.ca

Locations
Canada, Quebec
Pediatric Intensive Care Unit, The Montreal Children's Hospital, McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Diane Laforte, BA, CCRC    514-412-4400 ext 22521    diane.laforte@muhc.mcgill.ca   
Principal Investigator: Janet E Rennick, MSN, PhD         
Sponsors and Collaborators
McGill University Health Center
Groupe de recherche interuniversitaire en interventions en sciences infirmières du Québec (GRIISIQ)
Canadian Nurses Foundation (CNF)
Investigators
Principal Investigator: Janet E Rennick, MSN, PhD Montreal Children's Hospital, McGill University Health Center
  More Information

No publications provided

Responsible Party: Dr. Janet E. Rennick, The Montreal Children's Hospital of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT01176188     History of Changes
Other Study ID Numbers: 09-069-PED
Study First Received: August 4, 2010
Last Updated: August 18, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Pediatric Intensive Care Unit
Environmental Stressors
Sleep
Psychological Outcomes
Pediatrics

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 25, 2014