Pain Sensitivity Study for Child Development

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to investigate the role of physical pain in the link between childhood adversity and later psychopathology. Children who are participating in a larger longitudinal study will be asked to submerge their hand in cold water and hold it in the cold water as long as possible. Participants will do this twice, once alone and once holding the hand of their parent, to examine the role of parental support in pain development. The study will examine self-report of pain and salivary cortisol response to pain. It is hypothesized that children who have been exposed to more adversity will experience increased pain response and increased psychopathology symptoms. It is expected that higher social support in the family will decrease this relationship.

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 data supports the effectiveness of the treatment Parental Support Cold Pressor Task for child development?

The cold pressor task (CPT) has been used in many studies to understand pain and stress responses in children, showing that it can safely produce mild to moderate pain for research purposes. Although the CPT is not a treatment itself, it helps researchers study how children perceive pain and how factors like parental support might influence their pain experience. ^{1 2 3 4 5}

Is the Cold Pressor Task safe for children?

The Cold Pressor Task has been used in studies with over 1,700 children since 1937 without reported adverse effects, suggesting it is generally safe when conducted properly. ^{1 2 3 6 7}

How is the Parental Support Cold Pressor Task treatment different from other treatments for pain sensitivity in children?

The Parental Support Cold Pressor Task is unique because it involves immersing a child's hand or forearm in cold water to create a controlled pain experience, allowing researchers to study pain sensitivity and stress responses in a safe and ethical way. Unlike other treatments, it is not a drug but an experimental task that helps understand pain mechanisms in children without causing harm. ^{1 2 3 4 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Guidelines for the cold pressor task as an experimental pain stimulus for use with children. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Contemporary use of the cold pressor task in pediatric pain research: a systematic review of methods. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

An investigation of cold pressor pain in children (Part I). [2021]

4. United States 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. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The cold pressor test for the pediatric population: refinement of procedures, development of norms, and study of psychological variables. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Water temperature during the cold pressor test: A scoping review. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Validation of an automated bilateral feet cold pressor test. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

The association of early life stressors with pain sensitivity and pain experience at 22 years. [2021]