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Developing an Objective Measure of Experienced Pain

Primary Purpose

Pain, Acute

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Developing an objective measure of experienced pain
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain, Acute focused on measuring Measurement of Pain, Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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).

Sites / Locations

  • SNS Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Placebo Comparator

Experimental

No Intervention

Arm Label

Study 1 Low-Intensity Group

Study 1 High-Intensity Group

Study 2 Low-Intensity Group

Study 2 High-Intensity Group

Study 3 Placebo group

Study 3 Painkiller group

Study 4 test-retest reliability group

Arm Description

Control group which receives less intense electrical stimuli than the other.

Group which receives more intense electrical stimuli than the other.

Control group which receives less intense heat stimuli than the other.

Group which receives more intense heat stimuli than the other.

A group that receives a placebo cream.

A group that receives a topical analgesic such as EMLA cream.

Participants who participated in either Study 1 or 2 are recruited. They will experience both electrical and heat stimuli.

Outcomes

Primary Outcome Measures

Choices between monetary amounts and painful stimuli
Participants' choices between monetary amounts and painful stimuli
self-reported pain ratings according to Numerical Rating Scale (NRS)
self-reported pain ratings according to Numerical Rating Scale
self-reported pain ratings according to Visual Analogue Scale (VAS)
self-reported pain ratings according to Visual Analogue Scale
self-reported pain ratings according to general Labeled Magnitude Scale (gLMS)
self-reported pain ratings according to general Labeled Magnitude Scale
response times
Response times relative to participants' choices between monetary amounts and painful stimuli

Secondary Outcome Measures

heart rate variability
variation in heat-beat rate in reaction to the painful stimuli.
skin conductance
variation in skin conductance in reaction to the painful stimuli.
pupil dilation
variation in pupil dilation in reaction to the painful stimuli.

Full Information

First Posted
May 30, 2022
Last Updated
October 10, 2022
Sponsor
University of Zurich
Collaborators
Balgrist University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05415423
Brief Title
Developing an Objective Measure of Experienced Pain
Official Title
Developing an Objective Measure of Experienced Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
September 26, 2022 (Actual)
Study Completion Date
September 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Balgrist University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
Measurement of Pain, Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study 1 Low-Intensity Group
Arm Type
Active Comparator
Arm Description
Control group which receives less intense electrical stimuli than the other.
Arm Title
Study 1 High-Intensity Group
Arm Type
Experimental
Arm Description
Group which receives more intense electrical stimuli than the other.
Arm Title
Study 2 Low-Intensity Group
Arm Type
Active Comparator
Arm Description
Control group which receives less intense heat stimuli than the other.
Arm Title
Study 2 High-Intensity Group
Arm Type
Experimental
Arm Description
Group which receives more intense heat stimuli than the other.
Arm Title
Study 3 Placebo group
Arm Type
Placebo Comparator
Arm Description
A group that receives a placebo cream.
Arm Title
Study 3 Painkiller group
Arm Type
Experimental
Arm Description
A group that receives a topical analgesic such as EMLA cream.
Arm Title
Study 4 test-retest reliability group
Arm Type
No Intervention
Arm Description
Participants who participated in either Study 1 or 2 are recruited. They will experience both electrical and heat stimuli.
Intervention Type
Behavioral
Intervention Name(s)
Developing an objective measure of experienced pain
Intervention Description
At the beginning of each study, participants are randomly allocated into one of two groups. Within each group all participants are exposed to the same painful stimulus. One group experiences a painful stimulus of higher intensity compared to that of the other group. The painful stimuli are physically identical for every subject within the same group and within the standard of previous pain research. Participants are then asked to evaluate the painful stimulus they just received according to a self-reported scale (NRS, VAS, gLMS, NRS-MB). Participants are also asked to decide multiple times whether they prefer a larger amount of money and experience the same or more painful stimulus they received before or a smaller amount of money and no (or a less) painful stimulus. The smaller amount of money is progressively increased across choices until it matches the larger amount, similar to multiple price-list methods (MPL) which are standard in economics.
Primary Outcome Measure Information:
Title
Choices between monetary amounts and painful stimuli
Description
Participants' choices between monetary amounts and painful stimuli
Time Frame
baseline
Title
self-reported pain ratings according to Numerical Rating Scale (NRS)
Description
self-reported pain ratings according to Numerical Rating Scale
Time Frame
baseline
Title
self-reported pain ratings according to Visual Analogue Scale (VAS)
Description
self-reported pain ratings according to Visual Analogue Scale
Time Frame
baseline
Title
self-reported pain ratings according to general Labeled Magnitude Scale (gLMS)
Description
self-reported pain ratings according to general Labeled Magnitude Scale
Time Frame
baseline
Title
response times
Description
Response times relative to participants' choices between monetary amounts and painful stimuli
Time Frame
baseline
Secondary Outcome Measure Information:
Title
heart rate variability
Description
variation in heat-beat rate in reaction to the painful stimuli.
Time Frame
baseline
Title
skin conductance
Description
variation in skin conductance in reaction to the painful stimuli.
Time Frame
baseline
Title
pupil dilation
Description
variation in pupil dilation in reaction to the painful stimuli.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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).
Facility Information:
Facility Name
SNS Laboratory
City
Zürich
State/Province
CH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Developing an Objective Measure of Experienced Pain

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