Testing Therapeutic cuddling for pain
Official title: Therapeutic Cuddling in Critically Ill Children
Therapeutic Cuddling in Critically Ill Kids (THE ChICKS) Pilot Feasibility Randomized Controlled Trial
- 2 groups
- One site, in Calgary
- Recruiting
Interventions
- Other intervention
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)
- Other intervention
Standard of care
Cuddling or not as decided by the care team.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta
Eligibility Criteria
See who this study is looking for2 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +\- expected duration of admission of \> 48 hours.
Exclusion
- −Previously enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more →
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Therapeutic cuddling.
Registry label: A: Therapeutic cuddling
Group B, the comparison group, receives Standard of careStandard of careThe treatment normally given for a condition outside a study.Read more →.
Registry label: B: Standard of Care
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a maximum age of 18 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 112 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: From PICU admission to end of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → period (96 hours) or PICU discharge whichever occurs first.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Feasibility of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → — measured over From PICU admission to end of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → period (96 hours) or PICU discharge whichever occurs first.
Feasibility of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → — measured over From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first.
Ability to retain participants — measured over From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07562048 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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)
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Standard of careOther
Cuddling or not as decided by the care team.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From PICU admission to end of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → period (96 hours) or PICU discharge whichever occurs first.
The study as a whole is currently expected to finish around 2026-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 112 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Calgary, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This 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)
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.