Developing an Objective Measure of Experienced Pain
- Conditions
- Pain, Acute
- Interventions
- Behavioral: Developing an objective measure of experienced pain
- Registration Number
- NCT05415423
- Lead Sponsor
- University of Zurich
- Brief Summary
Pain is a public health challenge around the world. However, there is no single standardized measure of pain, to the point that the estimated prevalence of chronic pain in adults ranges between 2% and 64% depending on the methods and definitions used. Existing measures of pain are known to present several problems and results can be hardly compared between people.
The investigators propose and empirically validate a new, simple method to measure experienced pain in clinical trials. The method provides an objective, cardinal measurement of experienced pain which is comparable between people and the investigators test whether it is better able to measure experienced pain than existing procedures. The investigators test the new method in healthy participants using standard protocols (electrical and heat stimuli). The investigators also aim to validate the measure using a causal manipulation which relies on the administration of a topical analgesic product compared to a placebo.
- Detailed Description
The aim of this study is to establish and validate the proposed method of measuring pain using different pain stimuli. The investigators correlate these measurements with physiological data such as skin-conductance, heart-rate variability, pupil dilation, and with established measures of pain such as Numeric rating scale (NRS), Visual analog scale (VAS), general Labeled Magnitude Scale (gLMS). In addition, the investigators study the test-retest reliability of our measure of pain and its ability to capture a reduction in experienced pain due to a topical analgesic product compared to a placebo treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
- age 18-60 years.
- ability and willingness to participate in the study
- declaration of consent
- good English language skills (to ensure understanding of all instructions and the declaration of consent).
- inability to give the declaration of consent (e.g. due to linguistic difficulties understanding the study information)
- any neurological disorders
- reduced general health / chronic diseases (e.g. autoimmune disease, severe cardiovascular diseases, insulin-dependent diabetes, severe depression); chronic pain disorders
- pregnancy
- in the week before the experimental session self-reported intake of drugs which could influence pain perception (e.g. cannabis and ADHD medications).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study 1 High-Intensity Group Developing an objective measure of experienced pain Group which receives more intense electrical stimuli than the other. Study 1 Low-Intensity Group Developing an objective measure of experienced pain Control group which receives less intense electrical stimuli than the other. Study 2 Low-Intensity Group Developing an objective measure of experienced pain Control group which receives less intense heat stimuli than the other. Study 3 Placebo group Developing an objective measure of experienced pain A group that receives a placebo cream. Study 3 Painkiller group Developing an objective measure of experienced pain A group that receives a topical analgesic such as EMLA cream. Study 2 High-Intensity Group Developing an objective measure of experienced pain Group which receives more intense heat stimuli than the other.
- Primary Outcome Measures
Name Time Method self-reported pain ratings according to Numerical Rating Scale (NRS) baseline self-reported pain ratings according to Numerical Rating Scale
self-reported pain ratings according to general Labeled Magnitude Scale (gLMS) baseline self-reported pain ratings according to general Labeled Magnitude Scale
self-reported pain ratings according to Visual Analogue Scale (VAS) baseline self-reported pain ratings according to Visual Analogue Scale
response times baseline Response times relative to participants' choices between monetary amounts and painful stimuli
Choices between monetary amounts and painful stimuli baseline Participants' choices between monetary amounts and painful stimuli
- Secondary Outcome Measures
Name Time Method skin conductance baseline variation in skin conductance in reaction to the painful stimuli.
heart rate variability baseline variation in heat-beat rate in reaction to the painful stimuli.
pupil dilation baseline variation in pupil dilation in reaction to the painful stimuli.
Trial Locations
- Locations (1)
SNS Laboratory
🇨🇭Zürich, CH, Switzerland