Emotion Regulation and Pain in Children With Cancer

NCT03133507 | Completed

• 1 other identifier: UCCRCC-53097
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study tested the effects of emotion regulation strategies (reappraisal, reassurance, and empathy) on pain responses in children with cancer. Children with cancer were randomly assigned to one emotion regulation strategy during an experimental pain task (the cold pressor task \[CPT\]). During the CPT, children rated their pain and provided saliva samples immediately before, after, and then 15 minutes after the CPT. This study examined the influence of emotion regulation on self-reported pain and physiological activity assessed through saliva samples.

Conditions

Cancer

Keywords

cancer; salivary alpha amylase; pain; positive affect; emotion regulation strategies

Outcome Measures

Primary Outcomes (4)

• Pain Tolerance

  Time of hand removal from the cold pressor task was recorded and used to operationally define pain tolerance with longer durations reflecting greater pain tolerance. A four-minute ceiling was used such that children were instructed to remove their hand from the water after four-minutes if they had not already done so.

  4 mins

• Change in Salivary Alpha-Amylase

  Salivary alpha-amylase levels (a marker of autonomic nervous system activation) was assessed using the provided saliva samples.

  Immediately before, immediately after, and then 15 minutes after the cold pressor task.

• Self-reported pain

  Children were asked to report their pain when they removed their hand from the water using a numeric rating scale (NRS). Children ages 6 through 11 were asked "How much is it hurting right now?" on a scale of "Not hurting" = 0 to "Hurting a whole lot" = 10. Children 12 to 18 were asked "How much pain are you in right now?" on a scale of "No Pain at All" = 0 to "A Lot of Pain" = 10.

  The exact time that participants removed their hands from water, which can range from 0-4 minutes.

• Memory for pain

  Self-reported measure of how much their hand hurt during the cold pressor task.

  One week after the cold pressor task

Study Arms (3)

Reapprasial Condition

EXPERIMENTAL

Children in this condition will be instructed to think about how the procedure will help them become adjusted to cold weather.

Behavioral: Reapprasial Condition

Reassurance Condition

EXPERIMENTAL

Children will receive empathic support from the experimenter.

Behavioral: Reassurance Condition

Distraction Condition

EXPERIMENTAL

Children in this condition will be instructed to focus their attention on a picture on a computer screen rather than on the pain.

Behavioral: Distraction Condition

Interventions

Reapprasial Condition BEHAVIORAL

Children in this condition will be instructed to think about how the procedure will help them become adjusted to cold weather.

Reapprasial Condition

Reassurance Condition BEHAVIORAL

Children will be reassured by the experimenter .

Reassurance Condition

Distraction Condition BEHAVIORAL

Children in this condition will be instructed to focus their attention on a picture on a computer screen rather than on the pain.

Distraction Condition

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children between the ages of 6-18 years who were currently undergoing outpatient treatment for cancer and who could speak, read, and write in English or Spanish were eligible for the study.

You may not qualify if:

• Cognitive impairment, such as a developmental delay or mental retardation that would prevent children from participating in the experimental pain task.
• Children whose medical status require inpatient hospitalization or otherwise signify health complications that would prevent participation will not be recruited. Accordingly, all potential participants will be obtained via consultation with the Attending Oncology physician and/or nursing team.
• Following safety guidelines, participants will be excluded if they have a cut or sore on their non-dominant hand, have high blood pressure, or have a history of upper extremity vascular disease, cardiovascular disorder, fainting, seizures, frostbite, or chronic pain (pain lasting for more than 4 months).
• Because cortisol measures will be taken, participants will be asked to refrain from eating 1 hour before the experiment, as this can affect cortisol sample readings. In addition, because oral contraceptives can impact cortisol, participants taking hormone medications will be excluded from participation.

Sponsors & Collaborators

• University of California, Irvine: lead

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle Fortier

  505 S. Main Street Suite 940, Orange, Ca 92868

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 23, 2017
• First Posted: April 28, 2017
• Study Start: November 14, 2012
• Primary Completion: September 26, 2013
• Study Completion: September 26, 2013
• Last Updated: April 28, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share