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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176188
• Other study ID #: 09-069-PED
• Status: Completed
• Phase: Phase 1
• First received: August 4, 2010
• Last updated: September 23, 2015
• Start date: August 2010
• Est. completion date: July 2013

Study information

• Verified date: September 2015
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Psychological Stress
• Stress, Psychological

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Pediatric Intensive Care Unit, The Montreal Children's Hospital, McGill University Health Centre	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University Health Center	Canadian Nurses Foundation (CNF), Réseau de recherche portant sur les interventions en sciences infirmières du Québec (RRISIQ)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability and feasibility of the comfort intervention		Time 1: Pediatric Intensive Care Unit, post-intervention: Time 2: Hospital Ward; Time 3: 3 months post-discharge	No
Secondary	Child Distress		3 months post-Pediatric Intensive Care Unit discharge	No
Secondary	Child Comfort		During Pediatric Intensive Care Unit stay	No
Secondary	Parent Anxiety		Time 1: During child's Pediatric Intensive Care Unit stay; Time 2: 3 months post-discharge of child	No
Secondary	Child Anxiety		3 months post-discharge	No
Secondary	Child Sleep		Time 1: During Pediatric Intensive Care Unit stay; Time 2: Hospital Ward; Time 3: 3 months post-discharge	No