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

NCT01176188 | Completed Phase 1

• 1 other identifier: 09-069-PED
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.test the feasibility and acceptability of a PICU comfort care intervention that can be administered by nursing staff
2. 2.examine the feasibility and acceptability of data collection procedures
3. 3.pilot test outcome measures
4. 4.determine effect sizes to inform sample size calculation for a future multi-centred randomized controlled trial (RCT).

Conditions

Psychological Stress

Keywords

Pediatric Intensive Care Unit; Environmental Stressors; Sleep; Psychological Outcomes; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Child Distress

  3 months post-Pediatric Intensive Care Unit discharge

• Child Comfort

  During Pediatric Intensive Care Unit stay

• Parent Anxiety

  Time 1: During child's Pediatric Intensive Care Unit stay; Time 2: 3 months post-discharge of child

• Child Anxiety

  3 months post-discharge

• Child Sleep

  Time 1: During Pediatric Intensive Care Unit stay; Time 2: Hospital Ward; Time 3: 3 months post-discharge

Study Arms (2)

Comfort Care

EXPERIMENTAL

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

Other: Comfort Care

Usual Care

ACTIVE COMPARATOR

Other: Usual care

Interventions

Comfort Care OTHER

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.

Comfort Care

Usual care OTHER

Usual nursing care for the child in the Pediatric Intensive Care Unit, including usual parental involvement and usual exposure to unit noise levels.

Usual Care

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Réseau de recherche portant sur les interventions en sciences infirmières du Québec (RRISIQ): collaborator
• Canadian Nurses Foundation (CNF): collaborator

Study Sites (1)

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

Montreal, Quebec, H3H 1P3, Canada

Location

Related Publications (1)

• 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.

  PMID: 29659416 DERIVED

MeSH Terms

Conditions

Stress, Psychological

Interventions

Patient Comfort

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Janet E Rennick, MSN, PhD

  Montreal Children's Hospital, McGill University Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Scientist

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 5, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2013
• Last Updated: September 25, 2015

Record last verified: 2015-09

Locations

CA (1)