Centre Hospitalier Universitaire Saint-Etienne
Saint-Etienne, France
Location status: Recruiting
Location contact
Clement CORNEC, MD
SUB_INVESTIGATOR
Kasia PISANSKI, MD
SUB_INVESTIGATOR
Roland PEYRON, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04425395
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 production of vocalizations non-verbal communication influences pain tolerance in healthy adults.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Saint-Etienne, France
Location status: Recruiting
Clement CORNEC, MD
SUB_INVESTIGATOR
Kasia PISANSKI, MD
SUB_INVESTIGATOR
Roland PEYRON, MD
PRINCIPAL_INVESTIGATOR
Humans produce nonverbal vocalisations such as screams, grunts, roars, cries and laughter across a variety of contexts. Yet despite the prominence and apparent importance of these nonverbal sounds in human communication, the investigators still know very little about their influence on human perception and behaviour. That's why, in this study, the investigators will examine specifically the influence of nonverbal vocal production on pain tolerance.
The remainder of the study will involve up to three trials of a pain tolerance (cold pressor) task, during which the investigators will ask participants to produce vocalisations (e.g., screams or words) while submerging the participant's hand in bath of circulating cold water.
The results of the study will contribute to our theoretical understanding of the functions of nonverbal vocal communication in humans, in particular the influence of nonverbal vocal production (i.e., yelling) on pain tolerance.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
During the experiment, the vocalizations produced will be systematically recorded for each participant and an analysis of the acoustic structure of these vocalizations will be carried out.
Four sensors placed non-invasively on one finger. of the participants will be able to calculate a dozen physiological parameters converts in real time into a pain index called NOL (for Nociception Level Index).
This technique is based on the observation of the dilatation of the pupil during the perception of a nociceptive stimulus in test persons.
Time frame: at inclusion
Delay (in seconds) in removing the hand when testing the Cold Pressor.
Time frame: at inclusion
Participant verbally indicates when he or she begins to feel the sensation of pain (time of onset measured in seconds)
Time frame: at inclusion
Subjective assessment of maximum pain intensity by participants for a given trial.
Measured by scale of 0 (no pain) at 100 (extreme pain).
Time frame: at inclusion
Measurement of the NOL index (index ranging from 0 to 100) and measurement of pupillary diameter (in mm) and its variations in response to nociceptive stimuli by video pupillometry.
Time frame: at inclusion
Using a dedicated script in software specialised in acoustic analysis (e.g. PRAAT).
Contact information is provided by the study sponsor or research team.
Marie PEURIERE, CRA
CONTACT
(0)4.77.82.92.72 ext. +33
Roland PEYRON, MD
CONTACT
(0)477127805 ext. +33
Centre Hospitalier Universitaire de Saint Etienne
Other
Acronym: VOCPAIN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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