- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06851208
Do Emotions and Pain Combined Affect Mechanical Pain Thresholds and Other Pain-related Variables in Individuals with Chronic Pain?
February 26, 2025 updated by: Helena Gunnarsson, Linnaeus University
The purpose of this study is to investigate if different emotional states could influence mechanical pain thresholds and other pain - related variables such as pain tolerance, pain intensity and pain - related negative affect in individuals with chronic pain.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Participants with chronic pain will be randomized into 4 different groups watching different short video-clips (2.20 min), while at the same time experience short-lasting, experimentally induced pain.
The negative emotions group will watch an uncomfortable short video containing violence and blood, the positive emotions group will watch a video containing a stand-up comedy show, the neutral emotions group will watch a video about how to paint a house, and the control group will just wait for 2.20 min, without any instructions about what to think about.
Pressure pain thresholds, pain tolerance, pain intensity and pain-related negative affect will be measured with an algometer before and after the video-clip combined with experimental pain interventions.
Study Type
Interventional
Enrollment (Estimated)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Helena Gunnarsson, Dr
- Phone Number: +46708432509
- Email: helena.gunnarsson@lnu.se
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Above 18 years of age
- Fluent in Swedish
- Persistent chronic pain with duration > 6 months
Exclusion criteria:
- Known neurological disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Negative emotion, positive emotion, neutral emotion, control with experimental pain
Arm Description: The intervention includes either a negatively emotionally valenced video, a positively emotionally valenced video, a neutrally emotionally valenced video and experimental pain from the cold pressor test that are simultaneosly applied.
|
Emotional intervention Description: The participant will watch a short video-clip with negative emotional content while simultaneously experience experimentally induced pain.
Description: The participant will watch a short video-clip with positive emotional content while simultaneously experience experimentally induced pain.
Description: The participant will watch a short video-clip with neutral emotional content while simultaneously experience experimentally induced pain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure pain thresholds
Time Frame: Day 1: baseline PPTs are measured, intervention 2.20 min follows and intervention PPTs are measured directly after the intervention. Recruitment for single appointments for each participant will take place for 4 months.
|
Description: Pressure pain thresholds will be measured i kPa with a handheld algometer (Somedic AB).
|
Day 1: baseline PPTs are measured, intervention 2.20 min follows and intervention PPTs are measured directly after the intervention. Recruitment for single appointments for each participant will take place for 4 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain tolerance (time in seconds the left hand is immersed in cold water 1 degree C).
Time Frame: Day 1: During a single session (30 min), the participant will keep their hand immersed in cold water for as long as possible while watching a video. This time will be measured in seconds.
|
Description: The measure pain tolerance equals the time the time the participant keeps their left hand immersed in cold water (1 degree C), before they decide to withdraw their hand.
This will be measured in seconds.
For each participant, the maximum time to keep the hand immersed in water is 300 seconds.
Participants are successively recruited for single appointments for 4 months.
|
Day 1: During a single session (30 min), the participant will keep their hand immersed in cold water for as long as possible while watching a video. This time will be measured in seconds.
|
|
Pain intensity on the NRS
Time Frame: Day 1: Pain intensity will be estimated at single session appointments (30 min) on the NRS (Numerical Rating Scale) after the intervention. Participants will be successively recruited for single session appointments for 4 months.
|
Participants will rate their perceived pain intensity on the NRS (Numerical Rating Scale) after the intervention (film-clip combined with pain induction using the cold pressor apparatus with cold water 1 degree C.
This will take place on a single session appointment for each participant.
Participants will be successively recruited for single session appointments for 4 months.
|
Day 1: Pain intensity will be estimated at single session appointments (30 min) on the NRS (Numerical Rating Scale) after the intervention. Participants will be successively recruited for single session appointments for 4 months.
|
|
Pain-related negative affect on the NRS-A
Time Frame: Day 1: Pain intensity will be estimated at single session appointments (30 min) on the NRS-A (Numerical Rating Scale-Anxiety) after the intervention. Participants will be successively recruited for single session appointments for 4 months.
|
Description: Perceived pain-related negative affect will be estimated on the NRS-A (Numerical Rating Scale- Anxiety) after the intervention (film-clip combined with pain induction with the cold pressor apparatus with cold water 1 degree C).The pain intensity will be estimated at every single session appointment (30 min) after the intervention on the NRS (Numerical Rating Scale).
The participants will be successively recruited for single session appointments for 4 months.
|
Day 1: Pain intensity will be estimated at single session appointments (30 min) on the NRS-A (Numerical Rating Scale-Anxiety) after the intervention. Participants will be successively recruited for single session appointments for 4 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
February 21, 2025
First Submitted That Met QC Criteria
February 26, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 26, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-07781-01 ethic approval
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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