- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07802444
Do Different Arousal Levels Affect Pressure Pain Thresholds? (DDEALAPPT)
Do Different Emotional Arousal Levels Affect Pressure Pain Thresholds?
This study examines whether emotional arousal level alone, while maintaining positive emotional valence, can influence pressure pain thresholds (PPTs) in healthy adults. Pain perception is closely linked to emotional processes, and prior research indicates that emotional valence affects PPTs. However, the specific role of arousal level remains unclear. The study aims to isolate arousal by comparing high arousal positive emotion (humor) with low arousal positive emotion (pleasant video), and a no emotion control condition.
A total of 120 healthy participants will be randomly assigned to one of three groups: (1) humor induction (high valence, moderate-high arousal), (2) pleasant emotion induction (high valence, low arousal), or (3) mind wandering control. All participants will first view a neutral baseline video to standardize mood. PPTs will be measured bilaterally at the m. trapezius and m. tibialis anterior using a Somedic algometer (1 cm² probe, 30 kPa/s application rate). Three consecutive PPT measurements per site will be averaged. After the emotional induction (2:30 minutes), PPTs will be reassessed at all four sites.
Emotional responses will be validated using the Self Assessment Manikin (SAM) scale to measure valence and arousal. The humor video has been validated in earlier studies, whereas the pleasant low arousal video will be validated in a pre study. Inclusion criteria are age ≥18 and fluency in Swedish; exclusion criteria include pain during testing and known neurological disease.
The primary objective is to determine whether high arousal with positive valence increases PPTs (hypoalgesia) and whether low arousal with positive valence decreases PPTs (sensitization).
Statistical analyses include repeated measures t tests (Bonferroni corrected) and mixed model ANOVA. Nonparametric tests will be used if PPT distributions deviate from normality.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Helena Gunnarsson, PhD
- Phone Number: +46708432509
- Email: helena.gunnarsson@lnu.se
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Above 18 years of age, fluent in Swedish.
Exclusion Criteria:
- Pain anywhere in body during the test session, known neurological disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High arousal positive intervention
A high arousing video with positive content (humor) will be presented.
|
The high arousing video will be presented for 2.30 minutes.
|
|
Experimental: Low arousal positive intervention
A low arousing video with positive content will be presented.
|
A low arousing positive video will be presented for 2.30 min.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Pain Thresholds will be tested in m. trapezius and m. tibialis anterior using a hand-held algometer.
Time Frame: A baseline video is presented and immediately after PPT measurements are conducted. After that the intervention video is presented and immediately after PPT measurements are conducted.
|
Pressure Pain Thresholds will be tested in m. trapezius and m. tibialis anterior bilaterally using a hand-held algometer.
|
A baseline video is presented and immediately after PPT measurements are conducted. After that the intervention video is presented and immediately after PPT measurements are conducted.
|
|
Pressure Pain Thresholds
Time Frame: From experiencing the video and two minutes after
|
PPTs
|
From experiencing the video and two minutes after
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025-08788-01
- 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- Värkstadsstiftelsen (Other Identifier: Värkstadsstiftelsen)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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