CancerNCT03133507
Emotion Regulation and Pain in Children With Cancer
A study testing Reapprasial Condition, Reassurance Condition and Distraction Condition in people with Cancer, run by University of California, Irvine.
Trial 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]). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cancer
- What is being tested?
- Reapprasial Condition, Reassurance Condition and Distraction Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 14 Nov 2012to 26 Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the detailed description
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
- Cancer
- Being tested
- Reapprasial Condition, Reassurance Condition, Distraction Condition
- Keywords
- cancer, salivary alpha amylase, pain, positive affect, emotion regulation strategies
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reapprasial ConditionBehavioural
Children in this condition will be instructed to think about how the procedure will help them become adjusted to cold weather.
Reassurance ConditionBehavioural
Children will be reassured by the experimenter .
Distraction ConditionBehavioural
Children in this condition will be instructed to focus their attention on a picture on a computer screen rather than on the pain.
| Study group | Role | What they receive |
|---|---|---|
| Reapprasial Condition | Experimental | Children in this condition will be instructed to think about how the procedure will help them become adjusted to cold weather. Receives: Behavioral: Reapprasial Condition |
| Reassurance Condition | Experimental | Children will receive empathic support from the experimenter. Receives: 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. Receives: Behavioral: Distraction Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One week after the cold pressor task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start14 Nov 2012
- Primary completion26 Sep 2013
- Study completion26 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Fortier, University of California, Irvine
- Investigators
- Michelle Fortier, Principal investigator, 505 S. Main Street Suite 940, Orange, Ca 92868
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133507
- Sponsor's protocol ID
- UCCRCC-53097
- Status last verified
- Apr 2017
- First submitted
- 23 Apr 2017
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Reappraisal, Reassurance, and Distraction on Pain and Distress in Children Undergoing Treatment for Cancer
- ClinicalTrials.gov ID
- NCT03133507
- Acronym / sponsor ID
- UCCRCC-53097
- Conditions
- Cancer
- Keywords
- cancer, salivary alpha amylase, pain, positive affect, emotion regulation strategies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 14 Nov 2012 (actual)
- Primary completion
- 26 Sep 2013 (actual)
- Study completion
- 26 Sep 2013 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reapprasial Condition | Experimental | Behavioral: Reapprasial ConditionChildren in this condition will be instructed to think about how the procedure will help them become adjusted to cold weather. |
| Reassurance Condition | Experimental | Behavioral: Reassurance ConditionChildren will receive empathic support from the experimenter. |
| Distraction Condition | Experimental | Behavioral: Distraction ConditionChildren in this condition will be instructed to focus their attention on a picture on a computer screen rather than on the pain. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reapprasial ConditionChildren in this condition will be instructed to think about how the procedure will help them become adjusted to cold weather. | Behavioural | Reapprasial Condition |
| Reassurance ConditionChildren will be reassured by the experimenter . | Behavioural | Reassurance Condition |
| Distraction ConditionChildren in this condition will be instructed to focus their attention on a picture on a computer screen rather than on the pain. | Behavioural | Distraction Condition |
Primary outcome
Pain Tolerance
Time frame: 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.
Change in Salivary Alpha-Amylase
Time frame: 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.
Self-reported pain
Time frame: 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.
Memory for pain
Time frame: One week after the cold pressor task
Self-reported measure of how much their hand hurt during the cold pressor task.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Fortier principal investigator
505 S. Main Street Suite 940, Orange, Ca 92868
Questions about this trial
What is this clinical trial studying?
A study testing Reapprasial Condition, Reassurance Condition and Distraction Condition in people with Cancer, run by University of California, Irvine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Tolerance (time frame: 4 mins). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.