- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Helena Gunnarsson, PhD
- Telefonnummer: +46708432509
- E-mail: helena.gunnarsson@lnu.se
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Above 18 years of age, fluent in Swedish.
Exclusion Criteria:
- Pain anywhere in body during the test session, known neurological disease.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: High arousal positive intervention
A high arousing video with positive content (humor) will be presented.
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The high arousing video will be presented for 2.30 minutes.
|
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Eksperimentel: Low arousal positive intervention
A low arousing video with positive content will be presented.
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A low arousing positive video will be presented for 2.30 min.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pressure Pain Thresholds will be tested in m. trapezius and m. tibialis anterior using a hand-held algometer.
Tidsramme: 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.
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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
Tidsramme: From experiencing the video and two minutes after
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PPTs
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From experiencing the video and two minutes after
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2025-08788-01
- 2025 (U.S. NIH-bevilling/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- Värkstadsstiftelsen (Anden identifikator: Värkstadsstiftelsen)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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