此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Emotion Regulation and Pain in Children With Cancer

2017年4月25日 更新者:Michelle Fortier、University of California, Irvine

Effects of Reappraisal, Reassurance, and Distraction on Pain and Distress in Children Undergoing Treatment for Cancer

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

73

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 18年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Reapprasial Condition
Children in this condition will be instructed to think about how the procedure will help them become adjusted to cold weather.
Children in this condition will be instructed to think about how the procedure will help them become adjusted to cold weather.
实验性的:Reassurance Condition
Children will receive empathic support from the experimenter.
Children will be reassured by the experimenter .
实验性的: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.
Children in this condition will be instructed to focus their attention on a picture on a computer screen rather than on the pain.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Pain Tolerance
大体时间:4 mins
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
大体时间:Immediately before, immediately after, and then 15 minutes after the cold pressor task.
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
大体时间:The exact time that participants removed their hands from water, which can range from 0-4 minutes.
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
大体时间:One week after the cold pressor task
Self-reported measure of how much their hand hurt during the cold pressor task.
One week after the cold pressor task

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Michelle Fortier、505 S. Main Street Suite 940, Orange, Ca 92868

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2012年11月14日

初级完成 (实际的)

2013年9月26日

研究完成 (实际的)

2013年9月26日

研究注册日期

首次提交

2017年4月23日

首先提交符合 QC 标准的

2017年4月25日

首次发布 (实际的)

2017年4月28日

研究记录更新

最后更新发布 (实际的)

2017年4月28日

上次提交的符合 QC 标准的更新

2017年4月25日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • UCCRCC-53097

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅