A Nursing Intervention to Enhance Child Comfort and Psychological Well-Being During and Following PICU Hospitalization
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|ClinicalTrials.gov Identifier: NCT01176188|
Recruitment Status : Completed
First Posted : August 5, 2010
Last Update Posted : September 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Psychological Stress||Other: Comfort Care Other: Usual care||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||July 2013|
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.
|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.
- 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 ]
- Child Distress [ Time Frame: 3 months post-Pediatric Intensive Care Unit discharge ]
- Child Comfort [ Time Frame: During Pediatric Intensive Care Unit stay ]
- Parent Anxiety [ Time Frame: Time 1: During child's Pediatric Intensive Care Unit stay; Time 2: 3 months post-discharge of child ]
- Child Anxiety [ Time Frame: 3 months post-discharge ]
- Child Sleep [ Time Frame: Time 1: During Pediatric Intensive Care Unit stay; Time 2: Hospital Ward; Time 3: 3 months post-discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176188
|Pediatric Intensive Care Unit, The Montreal Children's Hospital, McGill University Health Centre|
|Montreal, Quebec, Canada, H3H 1P3|
|Principal Investigator:||Janet E Rennick, MSN, PhD||Montreal Children's Hospital, McGill University Health Center|