PainTHE ChICKSNCT07562048
Therapeutic Cuddling in Critically Ill Children
A study testing Therapeutic cuddling in people with Pain and Delirium in the Intensive Care Unit, run by University of Calgary at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pain, Delirium in the Intensive Care Unit
- What is being tested?
- Therapeutic cuddling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- 8 Dec 2025to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- expected duration of admission of > 48 hours.
Who cannot join
- Previously enrolled
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T2T5T3
Laurie A Lee, MN PhD, 403-220-6546, laurie.lee@ucalgary.ca
Simone Withecomb, simone.withecomb1@ucalgary.ca
About this study
Official title: Therapeutic Cuddling in Critically Ill Kids (THE ChICKS) Pilot Feasibility Randomized Controlled 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.
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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
- Determine treatment fidelity of participants randomized to the intervention arm.
- Determine the prevalence of the therapeutic cuddling intervention in those randomized to the standard of care arm.
- Determine the feasibility of measurement of key outcomes and co-variates (i.e., pain, agitation, sedation, delirium, analgosedation exposure, parental presence).
- 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)
- Conditions
- Pain, Delirium in the Intensive Care Unit
- Being tested
- Therapeutic cuddling, Standard of care
- Keywords
- Therapeutic cuddling, PICU, Pain, Delirium, Agitation
- Medical subject headings
- Pain, Delirium, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic cuddlingOther
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)
Standard of careOther
Cuddling or not as decided by the care team.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic cuddling | Experimental | Structured therapeutic cuddling intervention prescribed twice daily Receives: Other: Therapeutic cuddling |
| Standard of Care | Active comparator | No structured therapeutic cuddling prescription, but therapeutic cuddling not prevented. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of randomization
Proportion of those consented who are successfully randomized.
Measured: From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first
Feasibility of consent
Proportion of patients who are approached who provide consent.
Measured: From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first
Ability to retain participants
Proportion of randomized participants who complete study procedures
Measured: From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first
Secondary outcomes (5)
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
Measured: 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)
Proportion of participants with complete data entry for each variable of interest
Measured: From enrollment up to 14 study days or PICU discharge whichever occurs first
Describe the experience of patients in receiving the therapeutic cuddling intervention
Conduct 1:1 interviews for patients
Measured: Until the end of the study period, expected to complete within 18 months.
Describe the experiences of parents with therapeutic cuddling
1:1 interviews
Measured: Until the end of the study period, expected to completed within 18 months.
Experience of HCP with delivering Therapeutic Cuddling
1:1 Interviews
Measured: Until study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start8 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562048
- Sponsor's protocol ID
- REB25-0180
- Acronym
- THE ChICKS
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No