112 Participants NeededMy employer runs this trial

Therapeutic Cuddling for Pain in Critically Ill Children

(THE ChICKS Trial)

LA
Overseen ByLaurie A Lee, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether therapeutic cuddling can reduce pain and agitation in critically ill children in the ICU. The goal is to determine if structured cuddling sessions twice a day can serve as a viable alternative to standard pain medications, which often have side effects. Researchers aim to assess the effectiveness of this cuddling approach and gather feedback on it. Children expected to remain in the hospital for more than two days may qualify for this trial. As an unphased trial, it provides a unique opportunity for patients to contribute to innovative research that could enhance comfort and care for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that therapeutic cuddling is safe for critically ill children?

Research has shown that therapeutic cuddling, such as kangaroo care and comfort holding, may reduce pain and anxiety in very sick children. Past studies have safely used this type of cuddling with these children, and most healthcare professionals believe it could be widely implemented in children's intensive care units.

The main concerns involve safety during cuddling sessions and having sufficient staff to assist. However, these concerns focus more on the implementation rather than the cuddling itself. The treatment is generally well-received, with no major issues directly caused by the cuddling.

This approach has been safely used in similar situations, such as with newborns and healthy children, demonstrating benefits like reduced pain and improved immunity. Although specific data for very sick children is limited, existing evidence supports the safety of therapeutic cuddling as a non-drug method to manage pain and anxiety.12345

Why are researchers excited about this trial?

Researchers are excited about therapeutic cuddling for pain management in critically ill children because it offers a non-invasive, comforting approach that differs from traditional pharmacological treatments like pain medications. Unlike drugs that might have side effects or require monitoring for adverse reactions, therapeutic cuddling is a gentle intervention that could enhance emotional well-being while potentially reducing pain. The possibility of using human touch to naturally alleviate discomfort represents a novel avenue that could complement or even reduce the need for medication, making it an appealing option for both healthcare providers and families.

What evidence suggests that therapeutic cuddling might be an effective treatment for pain in critically ill children?

Research has shown that therapeutic cuddling, such as kangaroo care and comfort holding, can reduce pain and anxiety in both very sick newborns and healthy children. Studies have linked positive touch, like cuddling, to less pain, improved immunity, and even lower death rates. Although direct evidence for very sick children is limited, similar methods in other groups suggest potential benefits. Physical touch can trigger the release of hormones that help manage pain and stress. This trial will compare a structured therapeutic cuddling intervention, prescribed twice daily, with standard care where therapeutic cuddling is unstructured but not prevented. While more research is needed, early indications suggest that therapeutic cuddling could be beneficial in children's intensive care units.35678

Are You a Good Fit for This Trial?

This trial is for critically ill children admitted to the pediatric intensive care unit who are expected to stay more than 48 hours. Children with certain conditions or situations that prevent participation may be excluded.

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

96 hours
In-person at PICU

Treatment

Participants receive either structured therapeutic cuddling intervention or standard of care

Up to 14 days or until PICU discharge
Daily in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 18 months
1:1 interviews and data collection

What Are the Treatments Tested in This Trial?

Interventions

  • Therapeutic Cuddling

Trial Overview

The study compares therapeutic cuddling (like kangaroo care, comfort holding, and hugging) with standard medical care in the ICU. Participants are randomly assigned to either group to see if cuddling helps manage pain, agitation, and delirium.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Therapeutic cuddlingExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Alberta Children's Hospital

Collaborator

Trials
58
Recruited
44,700+

Citations

Therapeutic Cuddling for Pain in Critically Ill Children

These are associated with both short and long term negative sequelae including increased mortality, length of stay, rates of ICU delirium, worse ...

Identifying barriers and facilitators to therapeutic cuddling ...

TC is a potential intervention to prevent/manage pain, agitation, delirium, and analgosedation exposure in PICUs. However, it is not widely practiced.

Pain Management in Paediatric Critical Care: A Cross ... - PMC

In a recent study, 45% of children in the paediatric intensive care unit (PICU) experienced pain, and 24% had moderate to severe pain during a ...

A good cuddle just ain't enough!

The current study explored the relationship between parental proximal soothing behavior (eg cuddling, hugging, rocking, or patting) and infant pain regulation.

Comfort-holding in critically ill children: a scoping review

Comfort-holding is common during end-of-life care with 77.8% of children held, but rare during acute management (51% of children < three years, < 5% of ...

Therapeutic Cuddling in Critically Ill Kids: THE ChICKs Studies

Therapeutic cuddling is a potential intervention to address pediatric intensive care unit (PICU) pain, agitation, delirium, and analgosedation exposure.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41037838/

Identifying barriers and facilitators to therapeutic cuddling ...

Conclusions: Most PICU HCPs believe that TC can be implemented for all critically ill children. Important barriers include concerns about safety, staffing, and ...

THErapeutic Cuddling in Critically Ill Kids (THE ChICKs)

The THErapeutic Cuddling in Critically Ill Kids research program aims to evaluate therapeutic cuddling in critically ill children utilizing and integrated ...