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Recruiting NCT04425395

The Effect of Nonverbal Vocalisations on Pain Tolerance

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cold pressor task (CPT), Acoustic Recordings, Index measurement NOL™, Video pupillometry.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Behavioral 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 tria
  • Behavioral Acoustic Recordings
    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.
  • Diagnostic test Index measurement NOL™
    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).
  • Diagnostic test 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.

Primary outcome measures

  • Pain tolerance [Time frame: at inclusion]
Secondary outcome measures (4)
  • Onset of pain [Time frame: at inclusion]
  • Pain intensity [Time frame: at inclusion]
  • correlation between NOL index and pupillary diameter [Time frame: at inclusion]
  • Analysis of Acoustic Recordings [Time frame: at inclusion]

Eligibility criteria

Inclusion criteria

  • Participant in good health
  • Affiliated or entitled participant in a social security scheme
  • Participant who has received informed information about the study and has co-signed a consent to participate in the study with the investigator.

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
  • Chronic smoker (more than 10 cigarettes a day)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Centre Hospitalier Universitaire Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT04425395 · 19CH216 · 2020-A00277-32

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗