Therapeutic Cuddling in Critically Ill Children

NCT07562048 | Recruiting

• 1 other identifier: REB25-0180
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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. 1.Determine treatment fidelity of participants randomized to the intervention arm.
2. 2.Determine the prevalence of the therapeutic cuddling intervention in those randomized to the standard of care arm.
3. 3.Determine the feasibility of measurement of key outcomes and co-variates (i.e., pain, agitation, sedation, delirium, analgosedation exposure, parental presence).
4. 4.Describe the experience of patients, caregivers, and healthcare professionals in delivering/receiving the therapeutic cuddling intervention.

Conditions

Pain; Delirium in the Intensive Care Unit

Keywords

Therapeutic cuddling; PICU; Pain; Delirium; Agitation

Outcome Measures

Primary Outcomes (3)

• Feasibility of randomization

  Proportion of those consented who are successfully randomized.

  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.

  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

  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

  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)

  From enrollment up to 14 study days or PICU discharge whichever occurs first

• Describe the experience of patients in receiving the therapeutic cuddling intervention

  Until the end of the study period, expected to complete within 18 months.

• Describe the experiences of parents with therapeutic cuddling

  Until the end of the study period, expected to completed within 18 months.

• Experience of HCP with delivering Therapeutic Cuddling

  Until study completion, an average of 18 months

Study Arms (2)

Therapeutic cuddling

EXPERIMENTAL

Structured therapeutic cuddling intervention prescribed twice daily

Other: Therapeutic cuddling

Standard of Care

ACTIVE COMPARATOR

No structured therapeutic cuddling prescription, but therapeutic cuddling not prevented.

Other: Standard of care

Interventions

Therapeutic cuddling OTHER

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)

Therapeutic cuddling

Standard of care OTHER

Cuddling or not as decided by the care team.

Standard of Care

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- expected duration of admission of \> 48 hours.

You may not qualify if:

• Previously enrolled

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Children's Hospital: collaborator

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T2T5T3, Canada

RECRUITING

MeSH Terms

Conditions

Pain; Delirium; Psychomotor Agitation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Laurie A Lee, PhD

CONTACT

403-510-7661; laurie.lee@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 1, 2026
• Study Start: December 8, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)