Therapeutic Cuddling in Critically Ill Children (THE ChICKS)

April 27, 2026 updated by: University of Calgary

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.

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- expected duration of admission of > 48 hours.

Exclusion Criteria:

  • Previously enrolled

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic cuddling
Structured therapeutic cuddling intervention prescribed twice daily
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)
Active Comparator: Standard of Care
No structured therapeutic cuddling prescription, but therapeutic cuddling not prevented.
Other: Standard of care
Cuddling or not as decided by the care team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of randomization
Time Frame: From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first
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
Time Frame: From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first
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
Time Frame: From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Proportion of shifts with 1 or more cuddling events out of all shifts for 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)
Time Frame: From enrollment up to 14 study days or PICU discharge whichever occurs first
Proportion of participants with complete data entry for each variable of interest
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.
Conduct 1:1 interviews for patients
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.
1:1 interviews
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
1:1 Interviews
Until study completion, an average of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Alberta Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 27, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB25-0180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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