- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04473014
The Role of Sensory Processing Sensitivity in Pediatric Chronic Pain
Towards a Deeper Understanding of Chronic Pediatric Pain: Exploring the Role of Sensory Processing Sensitivity
Study Overview
Detailed Description
Background: Pain is defined as an unpleasant sensory and emotional experience and in its chronic form, pain is highly prevalent, up to 25% of children and adolescents are affected by it. The exact etiology of many forms of chronic pain remains unknown. One mechanism that has been proposed to underlie increased pain sensitivity is central sensitization, i.e., increased efficacy of the nervous system in transmitting pain signals, which manifests itself as a lower pain threshold. A lower pain threshold in turn has been recognized as a risk factor for the development of chronic pain. Being more sensitive to pain is one feature commonly shared by those with high sensory processing sensitivity (SPS), who are thought to react more strongly to both positive and negative environmental influences. The relationship between this increased sensitivity and pain tolerance has not been studied to date, but could contribute to our understanding of why some children and adolescents are more vulnerable to developing chronic pain than others.
Objectives and Aims: The aim of this project is to increase scientific understanding of whether the trait of SPS can help explain increased pain sensitivity and hence vulnerability for chronic pain. Additionally, it will be tested whether participants with high SPS report differences in pain intensity in response to positive, negative, or neutral mood induction compared to individuals with lower SPS.
Methods: To examine differences in pain perception of an experimentally induced pain stimulus between people with varying levels of SPS and whether pain perception can modulated by positive, negative, or neutral mood induction, I will apply a heat pain paradigm in a sample of healthy adolescents. Participants will be randomized to either neutral, positive or negative mood induction and I will test whether their pain sensitivity differs as a function of their scores on a high sensitivity scale and with regard to mood induction.
Expected Results: We expect highly sensitive adolescents to have a lower pain threshold and tolerance and to react more strongly to positive (with decreased pain ratings) and negative (with increased pain ratings) mood induction compared to those with lower scores on the sensitivity scale.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Basel, Switzerland, 40555
- Faculty of Psychology, University of Basel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy adolescents aged 16-19 years
Exclusion Criteria:
- Chronic pain or another chronic condition
- Skin pathologies
- Sensory abnormalities affecting the tactile or thermal modality
- Pregnancy
- Current medication
- Current psychological or psychiatric treatment
- Insufficient language skills to understand the instructions
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Positive Mood
This group will be exposed to a positive mood induction prior to heat pain.
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A standardized heat pain paradigm will be applied.
Pain threshold will be determined with the self-controlled search method starting at 32°C, with a mouse-click-induced increase of 0.1°C per click.
Pain tolerance is defined as the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus.
Participants will be instructed to continue with the task for as long as they can and to press a button if it becomes too uncomfortable or painful.
Temperature will then return to baseline.
To avoid physical injury, the measurement will stop automatically at a maximum temperature of 50°C.
|
Negative Mood
This group will be exposed to a negative mood induction prior to heat pain.
|
A standardized heat pain paradigm will be applied.
Pain threshold will be determined with the self-controlled search method starting at 32°C, with a mouse-click-induced increase of 0.1°C per click.
Pain tolerance is defined as the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus.
Participants will be instructed to continue with the task for as long as they can and to press a button if it becomes too uncomfortable or painful.
Temperature will then return to baseline.
To avoid physical injury, the measurement will stop automatically at a maximum temperature of 50°C.
|
Neutral Mood
This group will be exposed to a neutral mood induction prior to heat pain.
|
A standardized heat pain paradigm will be applied.
Pain threshold will be determined with the self-controlled search method starting at 32°C, with a mouse-click-induced increase of 0.1°C per click.
Pain tolerance is defined as the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus.
Participants will be instructed to continue with the task for as long as they can and to press a button if it becomes too uncomfortable or painful.
Temperature will then return to baseline.
To avoid physical injury, the measurement will stop automatically at a maximum temperature of 50°C.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Threshold
Time Frame: 1 day
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Temperature point where participants feel it changing from "hot" to "painful"
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1 day
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Pain Tolerance
Time Frame: 1 day
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the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus
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1 day
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Collaborators and Investigators
Investigators
- Principal Investigator: Helen Koechlin, PhD, University of Basel, Switzerland; Boston Children's Hospital, Boston, MA, USA
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Heat Pain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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