- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06611267
Experiences of Pain in Healthy Adults
En undersøgelse af Smerteoplevelsen Hos Raske forsøgsdeltagere (A Study of the Pain Experience in Healthy Participants)
The experiment aims to investigate the experience of pain in healthy adults and includes a total of 60 participants. Pain is a subjective experience that has a complicated neurological and psychological basis. Around 20% of the Danish population suffers from persistent pain, which has both personal and societal consequences. Personal consequences include, among others, reduced quality of life, loss of social life and risk of anxiety and depression. However, more knowledge is needed about which mechanisms are involved in the experience of pain, so that the treatment of patients with pain can be improved.
In the experiment, healthy participants will be inflicted with a tolerable pain on their forearm using a thermode. The application of heat causes pain for a short, limited period, but it is tolerable and without risks. During the experiment, the participants will be exposed to heat several times, with and without a cream on their forearm. It is a cream that has previously proved to have pain-relieving effects on participants in similar experiments. Participants will be asked about how they experience the intensity of the pain on a scale of 1-10 (0 = no pain and 10 = worst imaginable pain), and what they expect the pain intensity will be, also on a 1-10 scale. The participants are allowed to pause or stop the experiment anytime.
The experiment contributes to insights into pain and the mechanisms involved. This knowledge can in the future contribute with knowledge to improve the treatment of patients with pain. For the individual participant, the trial will contribute with knowledge about how they experience and assess pain themselves.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aarhus C, Denmark, 8000
- Aarhus University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Normal health, i.e. no known acute or chronic illness
- Fluid in Danish
Exclusion Criteria:
- Chronic pain condition
- Other medical or psychiatric disorder
- Use of antidepressants
- Daily use of painkillers
- Use of pain medication 24 hours prior to testing
- Drug abuse
- Pregnancy
- Studying or with completed education in psychology or journalism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participants assess their experienced pain
|
Participants will be inflicted with pain without cream on.
Patients are inflicted with pain after getting a cream on, which has previously had pain-relieving effects
|
|
Active Comparator: Participants assess their expected and experienced pain
|
Participants will be inflicted with pain without cream on.
Patients are inflicted with pain after getting a cream on, which has previously had pain-relieving effects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Experienced pain measured on a Visual Analogue Scale (VAS) from 0-10 (from no pain to worst imaginable pain) without cream compared to experienced pain measured on a Visual Analogue Scale (VAS) from 0-10 (from no pain to worst imaginable pain) with cream
Time Frame: From beginning to end of experiment, approx. 45 minutes
|
From beginning to end of experiment, approx. 45 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The effect of assessing expected pain intensity measured on a Visual Analogue Scale (VAS) from 0-10 (from no expected pain to worst imaginable expected pain)
Time Frame: From beginning to end of experiment, approx. 45 minutes
|
From beginning to end of experiment, approx. 45 minutes
|
Collaborators and Investigators
Sponsor
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 (Estimated)
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
- EXPERIENCES OF 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
product manufactured in and exported from the U.S.
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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