Ireland
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Recruiting Not applicable

The Effect of Exposure to Aversive Non-verbal Vocalizations on Pain Tolerance

NCT04423874 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-05-25
Last updated
2025-07-01

Condition(s) studied

Healthy

Investigational drug(s) / intervention(s)

Cold pressor task (CPT)index NOLPlayback ExperimentsVideo-pupillometry

Cold pressor task (CPT): The cold pressor test is among the most common and established methods for studying human reactions to pain and pain tolerance. Participants submerge a hand in cold water (approx. 5°C) and are asked to keep their hand submerged for as long as can (until the sensation is intolerable), up to a maximum of 5 min. The procedure is safe because the hand is removed before adverse effects can occur. The participant will be given a break of 5 min in between trials, and will interchange hands between trials. During this break hand may to be place in warm water (25-35°C) for up to 4 min to normalise hand temperature, which will be measured before and after each trial using a digital thermometer held firmly in the palm of the hand. Each participant will complete no more than three trials (conditions) in a randomised order.

index NOL: Measurement of the index NOL™: Four sensors, placed non-invasively on one of the four participants' fingers, will make it possible to calculate a dozen physiological parameters converts in real time into a pain index called NOL (for Nociception Level Index).

Playback Experiments: During the experience, participants are led to listen, via headphones, to aversive non-verbal vocalizations (baby crying). The sound levels used to broadcast the non-verbal vocalisations will be scrupulously measured using approved and certified equipment during the preparation of the experiments. These sound volumes will be chosen so as not to inconvenience participants.

Video-pupillometry: This technique is based on the observation of the dilatation of the pupil during the perception of a nociceptive stimulus in test persons.

Study summary

Humans produce non-verbal vocalizations (shouting, growling, screaming), laughter, ...) in various contexts that are likely to perform biological functions.

and important social issues. Yet despite their importance in the human vocal repertoire, the mechanisms and functions of non-verbal vocalizations remain little studied and poorly understood including in humans.

In this context, the investigators wish to examine how the perception of vocalizations non-verbal aversive behaviours influence pain tolerance in healthy adults.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Participant in good health * Affiliated or entitled participant in a social security scheme * Participant who received informed information about the study and co-signed, with the investigator, a consent to participate in the study Exclusion Criteria: * Chronic pain * High blood pressure or poor circulation * Cardiac or vascular disease, or a heart condition (including symptoms of Raynaud's syndrome) * Allergy or hypersensitivity to cold * Diabetes * Epilepsy * Pregnancy * Recent serious injury * Neurological or psychiatric condition known to affect pain tolerance (e.g., peripheral neuropathy, schizophrenia) * History of fainting or seizures * History of frostbite

Primary outcome measure(s)

  • Pain tolerance — at inclusion
    Delay (in seconds) in removing the hand when testing the Cold Pressor.

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier Universitaire SAINT-ETIENNE Saint-Etienne France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04423874 on ClinicalTrials.gov ↗ ← All trials in France