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Emotion Regulation and Pain in Children With Cancer

25 april 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

73

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

6 jaar tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Reapprasial Condition
Children in this condition will be instructed to think about how the procedure will help them become adjusted to cold weather.
Gedragsmatig: Reapprasial Condition
Children in this condition will be instructed to think about how the procedure will help them become adjusted to cold weather.
Experimenteel: Reassurance Condition
Children will receive empathic support from the experimenter.
Gedragsmatig: Reassurance Condition
Children will be reassured by the experimenter .
Experimenteel: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain Tolerance
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, Irvine

Onderzoekers

  • Hoofdonderzoeker: Michelle Fortier, 505 S. Main Street Suite 940, Orange, Ca 92868

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 november 2012

Primaire voltooiing (Werkelijk)

26 september 2013

Studie voltooiing (Werkelijk)

26 september 2013

Studieregistratiedata

Eerst ingediend

23 april 2017

Eerst ingediend dat voldeed aan de QC-criteria

25 april 2017

Eerst geplaatst (Werkelijk)

28 april 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 april 2017

Laatste update ingediend die voldeed aan QC-criteria

25 april 2017

Laatst geverifieerd

1 april 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • UCCRCC-53097

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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