Pain Sensitivity Study for Child Development

No longer recruiting at 1 trial location

Overseen By Susan Perlman, PHD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Not in CARE study

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how childhood adversity affects pain sensitivity and mental health later in life. Children will immerse their hand in cold water twice—once alone and once while holding a parent's hand—to assess how parental support influences their pain experience. This method is known as the Parental Support Cold Pressor Task. The study examines both self-reported pain levels and stress hormone levels in saliva. Children already participating in the ongoing CARE study are eligible to join. As an unphased trial, this study provides a unique opportunity to enhance understanding of the impact of parental support on childhood pain and stress.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Parental Support Cold Pressor Task is safe for children?

Research has shown that the Cold Pressor Task (CPT) reliably studies children's responses to pain. It involves placing a hand in cold water, causing mild to moderate pain, which increases slowly and remains harmless. One study found that about half of the children reached their pain limit within the first minute. This task is frequently used because it doesn't cause lasting harm or severe reactions. The study's focus on parental support adds an interesting aspect, but previous research strongly supports the task's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parental Support Cold Pressor Task because it explores how parental presence might influence a child's ability to manage pain. Unlike typical pain management methods, which often rely on medications or cognitive-behavioral techniques, this approach examines the emotional and psychological support parents can provide. The study aims to uncover the impact of parental support on pain tolerance, potentially leading to non-pharmacological strategies that leverage family dynamics to help children cope with pain more effectively.

What evidence suggests that the Parental Support Cold Pressor Task is effective for assessing pain sensitivity in children?

Research has shown that parental support can reduce the pain children feel. In this trial, children will participate in a Pain Assessment by submerging their hand in cold water, both alone and while holding a parent's hand. Studies suggest that a parent's presence can help the child feel less pain and cope better. Evidence indicates that simple actions, like holding a child's hand, can lessen the pain experienced during the test. While results may vary, a supportive parent generally helps manage pain. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for children already enrolled in the CARE study, focusing on how early hardships affect their mental health. It's not open to those who haven't participated in the CARE study.

Inclusion Criteria

Subjects who have been enrolled in our ongoing CARE study

Exclusion Criteria

Subjects who have not participated in the CARE study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pain Assessment

Children will submerge their hand in cold water and be asked to hold it in as long as possible, both alone and holding the hand of a parent

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the pain assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Parental Support Cold Pressor Task

Trial Overview

The study tests if physical pain links childhood adversity to later mental health issues. Kids will put their hand in cold water twice, once alone and once with a parent, to see if parental support affects pain and stress responses.

How Is the Trial Designed?

Group I: Pain Assessment Experimental Treatment 1 Intervention

Children will submerge their hand in cold water and be asked to hold it in as long as possible. They will do this both alone and holding the hand of a parent (counterbalanced).

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

The newly developed automated bilateral feet Cold Pressor Test (CPT) effectively eliminates biases associated with traditional hand immersion methods, such as laterality bias and motor response effects, making it a more reliable tool for stress research.

In a study with 28 healthy male students, the bilateral feet CPT produced significant physiological and subjective stress responses, indicating its validity and feasibility as a stress test that can be used in psychobiological research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of an automated bilateral feet cold pressor test. Bachmann, P., Zhang, X., Larra, MF., et al.[2019]

The study found that early life stress (ELS) can significantly affect pain sensitivity in young adults, with specific stressors like poor family functioning increasing the likelihood of heightened cold pain sensitivity, especially in those with moderate to high pain experiences.

Interestingly, more problematic behavior at age 2 was linked to lower pressure pain sensitivity at age 22, suggesting that not all early life stressors uniformly increase pain sensitivity, highlighting the complexity of how early experiences shape pain perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of early life stressors with pain sensitivity and pain experience at 22 years. Waller, R., Smith, AJ., O'Sullivan, PB., et al.[2021]

The study involved 141 healthy children and refined the cold pressor test (CPT) to better assess pain perception in the pediatric population, establishing norms for pain threshold and tolerance.

Results showed that 50% of the children reached pain tolerance within the first minute, and older children generally tolerated pain longer, while factors like gender and psychological variables did not significantly affect pain perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cold pressor test for the pediatric population: refinement of procedures, development of norms, and study of psychological variables. Trapanotto, M., Pozziani, G., Perissinotto, E., et al.[2019]

A scoping review of 331 trials using the cold pressor test (CPT) found that the most commonly reported water temperature was 1°C (33.8°F), which significantly affects pain tolerance outcomes.

Despite 93% of trials reporting water temperature, only 27% provided a precise range for temperature maintenance, highlighting the need for better standardization in future studies to ensure consistent and reliable results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Water temperature during the cold pressor test: A scoping review. Fanninger, S., Plener, PL., Fischer, MJM., et al.[2023]

The cold pressor task (CPT) is widely used in pediatric pain research, involving 2,242 children aged 3-18 years, but significant methodological inconsistencies were found in its implementation, such as variations in water temperature and the presence of observers.

The review suggests that these inconsistencies can impact pain outcomes and recommends refinements to improve the reliability and validity of CPT in future pediatric pain studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary use of the cold pressor task in pediatric pain research: a systematic review of methods. Birnie, KA., Petter, M., Boerner, KE., et al.[2018]

The study involved 48 children aged 8 to 14 and their parents, examining how variations in the cold pressor task (CPT) methodology, such as threat level and information about maximum immersion time, influenced perceptions of pain.

Children in the high-threat condition expected more pain and reported higher feelings of threat and catastrophizing, while those in the low-threat condition experienced less catastrophizing when informed about maximum immersion time, indicating that psychological factors play a significant role in pain perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Threat Level, Task Instruction, and Individual Characteristics on Cold Pressor Pain and Fear among Children and Their Parents. Boerner, KE., Noel, M., Birnie, KA., et al.[2018]

The cold pressor task (CPT) is a safe method for studying pain responses in children, having been used in over 24 studies with more than 1700 participants without any reported adverse effects.

To ensure consistency and reliability in results, it is recommended that the CPT be conducted using continuously circulating water at a temperature of 10 degrees C +/- 1 degree C, as variations in methodology may lead to conflicting findings in research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for the cold pressor task as an experimental pain stimulus for use with children. von Baeyer, CL., Piira, T., Chambers, CT., et al.[2022]

A pilot study involving 66 children aged 6-12 demonstrated that the cold pressor model of pain can be adapted for use in children, providing useful data on pain perception.

Children's pain ratings increased with longer immersion times and lower water temperatures, while both children and parents found the study format interesting and non-stressful, suggesting it is feasible to study pain in this age group with appropriate ethical considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigation of cold pressor pain in children (Part I). LeBaron, S., Zeltzer, L., Fanurik, D.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9883997/

The effectiveness of parental distraction during children's ...

Evidence suggests that parental distraction is effective in reducing children's acute pain responses, but findings are inconsistent across pain tolerance, ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S152659001200702X

Contemporary Use of the Cold Pressor Task in Pediatric ...

The cold pressor task (CPT) is an ethical experimental pain task widely used by pediatric pain researchers to examine a variety of important theoretical and ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3146755/

The Effects of Interactive and Passive Distraction on Cold ...

This study examined the effects of interactive versus passive distraction on healthy preschool-aged children's cold pressor pain tolerance.

4.

jpain.org

jpain.org/article/S1526-5900(05)00366-4/fulltext

Guidelines for the cold pressor task as an experimental ...

The cold pressor task (CPT) involves placing a hand or forearm in cold water, a stimulus that produces a slowly mounting pain of mild to moderate intensity.

5.

academic.oup.com

academic.oup.com/jpepsy/article/34/7/749/905898

Cold Pressor Test for the Pediatric Population: Refinement of ...

Methods After a phase of adaptation in a water bath (24–27°C), the child immersed one arm in cold water (10°C) and reported pain threshold and tolerance.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/18845586/

The cold pressor test for the pediatric population

Pain tolerance was reached within the first minute by 50% of the children. Pain intensity affected the children's emotional status. Older children tolerated ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03083626

The Effects of Water Temperature on the Cold Pressor Test

The purpose of this study is to examine how the water temperature of the cold pressure test might affect the participants' response (i.e., the participants pain ...