Menu
Recruiting NCT04423874

The Effect of Exposure to Aversive Non-verbal Vocalizations 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), index NOL, Playback Experiments, 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 perception of vocalizations non-verbal aversive behaviours influence 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 perception 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 listen to vocalisations (e.g., babies' cries or babbling) while submerging the participant's hand in bath of circulating cold water.

The results of the study will contribute to theoretical understanding of the functions of nonverbal vocal communication in humans, in particular the influence of nonverbal vocal and perception (of babies' cries) 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 t
  • Diagnostic test 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).
  • Behavioral 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.
  • 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 (3)
  • Onset of pain [Time frame: at inclusion]
  • Pain intensity [Time frame: at inclusion]
  • Correlation between NOL index and video pupillometry results [Time frame: at inclusion]

Eligibility criteria

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

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: NCT04423874 · 19CH215 · 2020-A00274-35

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗