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

Primary Purpose

Psychological Stress

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Comfort Care
Usual care
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychological Stress focused on measuring Pediatric Intensive Care Unit, Environmental Stressors, Sleep, Psychological Outcomes, Pediatrics

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pediatric Intensive Care Unit, The Montreal Children's Hospital, McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Comfort Care

Usual Care

Arm Description

Parental soothing, including tactile and auditory strategies, followed by a quiet period with the application of earmuffs to block auditory stimulation

Outcomes

Primary Outcome Measures

Acceptability and feasibility of the comfort intervention

Secondary Outcome Measures

Child Distress
Child Comfort
Parent Anxiety
Child Anxiety
Child Sleep

Full Information

First Posted
August 4, 2010
Last Updated
September 23, 2015
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Réseau de recherche portant sur les interventions en sciences infirmières du Québec (RRISIQ), Canadian Nurses Foundation (CNF)
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1. Study Identification

Unique Protocol Identification Number
NCT01176188
Brief Title
A Nursing Intervention to Enhance Child Comfort and Psychological Well-Being During and Following PICU Hospitalization
Official Title
A Nursing Intervention to Enhance Comfort and Promote Psychological Well-Being in Children During and Following PICU Hospitalization: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Réseau de recherche portant sur les interventions en sciences infirmières du Québec (RRISIQ), Canadian Nurses Foundation (CNF)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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: test the feasibility and acceptability of a PICU comfort care intervention that can be administered by nursing staff examine the feasibility and acceptability of data collection procedures pilot test outcome measures 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress
Keywords
Pediatric Intensive Care Unit, Environmental Stressors, Sleep, Psychological Outcomes, Pediatrics

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comfort Care
Arm Type
Experimental
Arm Description
Parental soothing, including tactile and auditory strategies, followed by a quiet period with the application of earmuffs to block auditory stimulation
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Comfort Care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual nursing care for the child in the Pediatric Intensive Care Unit, including usual parental involvement and usual exposure to unit noise levels.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Child Distress
Time Frame
3 months post-Pediatric Intensive Care Unit discharge
Title
Child Comfort
Time Frame
During Pediatric Intensive Care Unit stay
Title
Parent Anxiety
Time Frame
Time 1: During child's Pediatric Intensive Care Unit stay; Time 2: 3 months post-discharge of child
Title
Child Anxiety
Time Frame
3 months post-discharge
Title
Child Sleep
Time Frame
Time 1: During Pediatric Intensive Care Unit stay; Time 2: Hospital Ward; Time 3: 3 months post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet E Rennick, MSN, PhD
Organizational Affiliation
Montreal Children's Hospital, McGill University Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Intensive Care Unit, The Montreal Children's Hospital, McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29659416
Citation
Rennick JE, Stremler R, Horwood L, Aita M, Lavoie T, Majnemer A, Antonacci M, Knox A, Constantin E. A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children: Soothing Through Touch, Reading, and Music. Pediatr Crit Care Med. 2018 Jul;19(7):e358-e366. doi: 10.1097/PCC.0000000000001556.
Results Reference
derived

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

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