Therapeutic Cuddling in Critically Ill Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorUniversity of Calgary
About this trial
2.1 CONTEXT Pain and agitation are common comorbidities of pediatric critical illness due to both underlying disease processes and ICU related therapies. These are associated with both short and long term negative sequelae including increased mortality, length of stay, rates of ICU delirium, worse sleep, increased anxiety, depression, and chronic pain. The current standard of care to manage PICU associated pain and agitation is the use of analgosedation (e.g. opioids and benzodiazepines) these too are associated with increased time on the ventilator, length of stay, ICU delirium, and long term mental health and negative neuro-cognitive outcomes. Despite recommendations for increased use of non-pharmacologic therapies in the prevention and management of PICU associated pain, agitation, delirium, and analgosedation exposure, there are currently know therapies with clear evidence of efficacy.
Therapeutic cuddling (e.g. kangaroo care, clothed cuddling, comfort holding, etc.) has been shown to decrease pain and anxiety in critically ill neonates, and healthy children and adults. Positive affective touch and hugging has known physiologic benefits and has been associated with decreased pain, improved immunity, and decreased mortality. Despite the potential for this intervention to aid in the prevention and management of PICU associated pain, agitation, delirium and analgosedation exposure, little data exists on efficacy of therapeutic cuddling in critically ill children.
2.2 OBJECTIVES 2.2.1 Primary Determine the feasibility of screening, consent, randomization, and retention of participants in a pragmatic RCT of therapeutic cuddling versus standard of care in the Alberta Children's Hospital Pediatric Intensive Care Unit.
2.2.2 Secondary
1. Determine treatment fidelity of participants randomized to the intervention arm. 2. Determine the prevalence of the therapeutic cuddling intervention in those randomized to the standard of care arm. 3. Determine the feasibility of measurement of key outcomes and co-variates (i.e., pain, agitation, sedation, delirium, analgosedation exposure, parental presence). 4. Describe the experience of patients, caregivers, and healthcare professionals in delivering/receiving the therapeutic cuddling intervention.
2.3 STUDY DESIGN Pilot feasibility randomized controlled trial of a structured co-designed therapeutic cuddling intervention as compared to the standard of care in a single tertiary care PICU.
2.4 DURATION 6 months to 1 year 2.5 LOCATION, DEPARTMENTS, AND FACILITY WHERE RESEARCH WILL BE UNDERTAKEN The pediatric intensive care unit at the Alberta Children's Hospital 2.6 SAMPLE SIZE A total sample size of 112 participants (56 per arm)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Previously enrolled
Trial design
Design model
Parallel
Treatments tested in this trial
Therapeutic cuddling
Other interventionIn bed or out of bed cuddling provided by a caregiver that involves at least two points of body contact with at least one providing pressure (e.g. arm over the torso or child in lap of parent)
Standard of care
Other interventionCuddling or not as decided by the care team.
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: Therapeutic cuddlingExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of randomization
Proportion of those consented who are successfully randomized.
Time frame
From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first2
Feasibility of consent
Proportion of patients who are approached who provide consent.
Time frame
From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first3
Ability to retain participants
Proportion of randomized participants who complete study procedures
Time frame
From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs firstSecondary outcomes
1
Prevalence of the therapeutic cuddling intervention in those randomized to the standard of care arm
Proportion of shifts with 1 or more cuddling events out of all shifts for those randomized to the standard of care arm
Time frame
From enrollment up to 14 study days or PICU discharge, whichever occurs first.2
Feasibility of measurement of key outcomes and co-variates (i.e., pain, agitation, sedation, delirium, analgosedation exposure, parental presence)
Proportion of participants with complete data entry for each variable of interest
Time frame
From enrollment up to 14 study days or PICU discharge whichever occurs first3
Describe the experience of patients in receiving the therapeutic cuddling intervention
Conduct 1:1 interviews for patients
Time frame
Until the end of the study period, expected to complete within 18 months.4
Describe the experiences of parents with therapeutic cuddling
1:1 interviews
Time frame
Until the end of the study period, expected to completed within 18 months.Sponsors and contacts
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University of Calgary
Lead sponsor
Alberta Children's Hospital
Collaborator
Source ClinicalTrials.gov