NCT07562048 Therapeutic Cuddling in Critically Ill Children
| NCT ID | NCT07562048 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Calgary |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2025-12-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 112 participants in total. It began in 2025-12-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: \- expected duration of admission of \> 48 hours. Exclusion Criteria: * Previously enrolled
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07562048 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07562048 currently recruiting?
Yes, NCT07562048 is actively recruiting participants. Contact the research team at laurie.lee@ucalgary.ca for enrollment information.
Where is the NCT07562048 trial being conducted?
This trial is being conducted at Calgary, Canada.
Who is sponsoring the NCT07562048 clinical trial?
NCT07562048 is sponsored by University of Calgary. The trial plans to enroll 112 participants.