An interventional study of Therapeutic cuddling and Standard of care in Pain and Delirium in the Intensive Care Unit, sponsored by University of Calgary. Recruiting at 1 site in Canada. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Calgary · Not applicable, Interventional, and Treatment
Among 461 studies in Pain with a site in Canada — 62 open to participants now, 66 under way, 1 of them phase 3. Pain · Canada.
Among the 461 studies in Pain with a site in Canada, this one is the 130th largest by planned enrollment of the 417 interventional ones that give a count, is one of 14 that started in 2025, is one of 215 with no phase, reaches primary completion later than 28 of the 65 other live ones, and was the 435th registered.
10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.
Browse Pain studies →62 of the 461 studies in Pain with a site in Canada are open now. Recruiting first, the newest first:
University of British Columbia · Sites in Canada
Ages 50+
University of British Columbia · Sites in Canada
Ages 19+ · Women only
St. Justine's Hospital · Sites in Canada
Ages 18+ · Women only
London Health Sciences Centre Research Institute · Sites in Canada
Ages 1–17
Universite de Picardie Jules Verne · Sites in Canada, France
Ages 18–35 · Healthy volunteers
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: Up to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
461 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 27 · Phase 2 67 · Phase 3 74 · Phase 4 48
First in 1997; this study’s year is marked. 14 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 112 is above the median of 66 across 8,497 interventional studies indexed under Pain.
Median enrollment 65 across the 417 interventional studies, 153 across the 42 observational. Of the 325 that completed or were terminated, 49 (15%) have results posted.
This tab as a report to print or save as PDF → With an account.
76 of 461 have an industry lead sponsor. The 10 most frequent:
University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
University of Calgary has 9 studies filed under Pain — fewer than ten, so there is no comparison to draw.
26 of the studies in Pain with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT07681180Olivier F. BertrandEvaluation of Anxiety Reduction in the Cathlab by Means of Pharmacological and Non-pharmacological Strategies | 2026-12 |
| NCT07562048University of CalgaryTherapeutic Cuddling in Critically Ill Children | 2026-12 |
| NCT07447830McGill UniversityThe Pain Reduction Using Immersive Virtual Reality During Wound Care Evaluation Study at Maimonides (PRISM) - Pilot Study | 2026-12-01 |
| NCT07016373Nancy MouradianRole of Manuka Honey in Lowering Pain and Boosting Healing After Gum Graft Surgery. | 2026-12-26 |
Add all 26 to your calendar (.ics) → With an account.
Among the 461 studies in Pain with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- expected duration of admission of > 48 hours.
Exclusion Criteria:
Structured therapeutic cuddling intervention prescribed twice daily
Other: Therapeutic cuddling
No structured therapeutic cuddling prescription, but therapeutic cuddling not prevented.
Other: Standard of care
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)
Cuddling or not as decided by the care team.
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 first
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 first
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 first
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.
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 first
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.
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.
Experience of HCP with delivering Therapeutic Cuddling
1:1 Interviews
Time frame: Until study completion, an average of 18 months
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.
Of 3,734 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 12 months is above that.
Counting every sponsor, half of 3,833 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.