Clinical trial NCT01176188: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psychological Stress
Keywords: Pediatric Intensive Care Unit
Environmental Stressors
Sleep
Psychological Outcomes
Pediatrics
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Réseau de recherche portant sur les interventions en sciences infirmières du Québec (RRISIQ)
name: Canadian Nurses Foundation (CNF)
First posted: 2010-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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.

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 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

Primary outcomes:
measure: Acceptability and feasibility of the comfort intervention
timeFrame: Time 1: Pediatric Intensive Care Unit, post-intervention: Time 2: Hospital Ward; Time 3: 3 months post-discharge
Secondary outcomes:
measure: Child Distress
timeFrame: 3 months post-Pediatric Intensive Care Unit discharge
measure: Child Comfort
timeFrame: During Pediatric Intensive Care Unit stay
measure: Parent Anxiety
timeFrame: Time 1: During child's Pediatric Intensive Care Unit stay; Time 2: 3 months post-discharge of child
measure: Child Anxiety
timeFrame: 3 months post-discharge
measure: Child Sleep
timeFrame: Time 1: During Pediatric Intensive Care Unit stay; Time 2: Hospital Ward; Time 3: 3 months post-discharge
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Pediatric Intensive Care Unit, The Montreal Children's Hospital, McGill University Health Centre
state: Quebec
Study officials:
affiliation: Montreal Children's Hospital, McGill University Health Center
name: Janet E Rennick, MSN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.