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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04473014
Other study ID # Heat Pain
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 21, 2021
Est. completion date May 15, 2022

Study information

Verified date May 2022
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 15, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 19 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Heat Pain Paradigm
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.

Locations

Country Name City State
Switzerland Faculty of Psychology, University of Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Threshold Temperature point where participants feel it changing from "hot" to "painful" 1 day
Primary Pain Tolerance the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus 1 day
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