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Emotion Regulation and Pain in Children With Cancer

NCT ID: NCT03133507

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-14

Study Completion Date

2013-09-26

Brief Summary

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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.

Detailed Description

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More than 12,000 children are diagnosed with cancer in the United States each year and the majority of these children will experience pain throughout their illness. Children with cancer are required to undergo repeated invasive medical procedures, including bone marrow aspirations (BMA) and lumbar punctures (LP), which have been described by children as the most distressing and painful aspect of their illness. The experience and memory of procedural pain can have a lasting effect and impact distress in future procedures; children learn to anticipate pain and show increased distress and decreased cooperation at subsequent procedures. Moreover, childhood medical distress has also been linked to adults' reports of pain and fear around medical events and even avoidance of future health care. Early painful procedures have also been associated with behavioral changes to medical events later in life, a finding that is supported by recent physiological evidence indicating that activation of the pain processing system in the brain can change neuropathways, which leads to increased sensitivity to later stimulation of pain systems. Therefore, it is vital to develop strategies to minimize the pain and distress that children undergo through cancer treatment and understanding the impact of children's memory on pain is a crucial step in this process.

To address this important need, this study involved identifying the strategies that children use to cope with distress that promote positive memories of medical events, examining how these strategies impact their immediate physiology (via salivary biomarkers) and self-reported pain, and understanding how these coping strategies change children's distress over time during future medical procedures. Specifically, certain coping strategies change the way that children interpret stressful medical procedures, which affects the emotional response to future procedures. These objectives were accomplished by the following specific aims:

Aim 1: Identify emotion-regulation (i.e., coping) strategies that promote more positive memories of distressing medical procedures in children with cancer.

Aim 2: Assess the impact of emotion-regulation strategies on children's distress response to painful procedures over time.

This project will provide specific means for impacting children's pain and distress during medical procedures. Specifically, because the emotion regulation strategies described in this protocol are modifiable and teachable, they provide direct implications for clinical practice in pain management by identifying strategies that can decrease children's pain and anxiety throughout their course of cancer treatment.

Conditions

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Cancer

Keywords

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cancer salivary alpha amylase pain positive affect emotion regulation strategies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Reapprasial Condition

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

Group Type EXPERIMENTAL

Reapprasial Condition

Intervention Type BEHAVIORAL

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

Reassurance Condition

Children will receive empathic support from the experimenter.

Group Type EXPERIMENTAL

Reassurance Condition

Intervention Type BEHAVIORAL

Children will be reassured by the experimenter .

Distraction Condition

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

Group Type EXPERIMENTAL

Distraction Condition

Intervention Type BEHAVIORAL

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

Interventions

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Reapprasial Condition

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

Intervention Type BEHAVIORAL

Reassurance Condition

Children will be reassured by the experimenter .

Intervention Type BEHAVIORAL

Distraction Condition

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Michelle Fortier

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle Fortier

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

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UCCRCC-53097

Identifier Type: -

Identifier Source: org_study_id