NCT04473014

Brief Summary

The aim of this project is to increase scientific understanding of whether the trait of SPS can help explain increased pain sensitivity and hence vulnerability for chronic pain. Additionally, it will be tested whether participants with high SPS report differences in pain intensity in response to positive, negative, or neutral mood induction compared to individuals with lower SPS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

June 21, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

June 30, 2020

Last Update Submit

May 17, 2022

Conditions

Keywords

sensory processing sensitivity

Outcome Measures

Primary Outcomes (2)

  • Pain Threshold

    Temperature point where participants feel it changing from "hot" to "painful"

    1 day

  • Pain Tolerance

    the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus

    1 day

Study Arms (3)

Positive Mood

This group will be exposed to a positive mood induction prior to heat pain.

Behavioral: Heat Pain Paradigm

Negative Mood

This group will be exposed to a negative mood induction prior to heat pain.

Behavioral: Heat Pain Paradigm

Neutral Mood

This group will be exposed to a neutral mood induction prior to heat pain.

Behavioral: Heat Pain Paradigm

Interventions

A standardized heat pain paradigm will be applied. Pain threshold will be determined with the self-controlled search method starting at 32°C, with a mouse-click-induced increase of 0.1°C per click. Pain tolerance is defined as the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus. Participants will be instructed to continue with the task for as long as they can and to press a button if it becomes too uncomfortable or painful. Temperature will then return to baseline. To avoid physical injury, the measurement will stop automatically at a maximum temperature of 50°C.

Negative MoodNeutral MoodPositive Mood

Eligibility Criteria

Age16 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from local schools and at the University of Basel, Switzerland.

You may qualify if:

  • Healthy adolescents aged 16-19 years

You may not qualify if:

  • Chronic pain or another chronic condition
  • Skin pathologies
  • Sensory abnormalities affecting the tactile or thermal modality
  • Pregnancy
  • Current medication
  • Current psychological or psychiatric treatment
  • Insufficient language skills to understand the instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Psychology, University of Basel

Basel, 40555, Switzerland

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Helen Koechlin, PhD

    University of Basel, Switzerland; Boston Children's Hospital, Boston, MA, USA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Senior Researcher

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 16, 2020

Study Start

June 21, 2021

Primary Completion

April 30, 2022

Study Completion

May 15, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations