Therapeutic Cuddling in Critically Ill Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Therapeutic cuddling, Standard of care.
- Who it may be relevant to
- Registry conditions: Pain, Delirium in the Intensive Care Unit. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Therapeutic Cuddling in Critically Ill Kids (THE ChICKS) Pilot Feasibility Randomized Controlled Trial
Overview
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)
Interventions
- Other Therapeutic cuddling
In 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) - Other Standard of care
Cuddling or not as decided by the care team.
Primary outcome measures
- Feasibility of randomization [Time frame: From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first]
- Feasibility of consent [Time frame: From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first]
- Ability to retain participants [Time frame: From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first]
Secondary outcome measures (5)
- Prevalence of the therapeutic cuddling intervention in those randomized to the standard of care arm [Time frame: From enrollment up to 14 study days or PICU discharge, whichever occurs first.]
- Feasibility of measurement of key outcomes and co-variates (i.e., pain, agitation, sedation, delirium, analgosedation exposure, parental presence) [Time frame: From enrollment up to 14 study days or PICU discharge whichever occurs first]
- Describe the experience of patients in receiving the therapeutic cuddling intervention [Time frame: Until the end of the study period, expected to complete within 18 months.]
- Describe the experiences of parents with therapeutic cuddling [Time frame: Until the end of the study period, expected to completed within 18 months.]
- Experience of HCP with delivering Therapeutic Cuddling [Time frame: Until study completion, an average of 18 months]
Eligibility criteria
Inclusion criteria
\- expected duration of admission of > 48 hours.
Exclusion criteria
- Previously enrolled
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Alberta Children's Hospital — Calgary
Identifiers
NCT: NCT07562048 · REB25-0180