Emotion Regulation and Pain in Children With Cancer
Effects of Reappraisal, Reassurance, and Distraction on Pain and Distress in Children Undergoing Treatment for Cancer
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Reapprasial Condition
Children in this condition will be instructed to think about how the procedure will help them become adjusted to cold weather.
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Children in this condition will be instructed to think about how the procedure will help them become adjusted to cold weather.
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実験的:Reassurance Condition
Children will receive empathic support from the experimenter.
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Children will be reassured by the experimenter .
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実験的: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.
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Children in this condition will be instructed to focus their attention on a picture on a computer screen rather than on the pain.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain Tolerance
時間枠: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.
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4 mins
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Change in Salivary Alpha-Amylase
時間枠:Immediately before, immediately after, and then 15 minutes after the cold pressor task.
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Salivary alpha-amylase levels (a marker of autonomic nervous system activation) was assessed using the provided saliva samples.
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Immediately before, immediately after, and then 15 minutes after the cold pressor task.
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Self-reported pain
時間枠:The exact time that participants removed their hands from water, which can range from 0-4 minutes.
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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.
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The exact time that participants removed their hands from water, which can range from 0-4 minutes.
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Memory for pain
時間枠:One week after the cold pressor task
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Self-reported measure of how much their hand hurt during the cold pressor task.
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One week after the cold pressor task
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協力者と研究者
捜査官
- 主任研究者:Michelle Fortier、505 S. Main Street Suite 940, Orange, Ca 92868
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- UCCRCC-53097
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
癌の臨床試験
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Novartis Pharmaceuticals終了しましたメラノーマ | 高度なEGFR変異体非小さな細胞肺cancer(NSCLC) | KRAS G12変異NSCLC | 食道扁平上皮がん(SCC) | ヘッド/ネックSCC | 進行した胃腸間質腫瘍(GIST) | 進行したNRAS/BRAFT WT皮膚黒色腫アメリカ, 台湾, オランダ, カナダ, スペイン, シンガポール, イタリア, 日本, 韓国
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