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

NCT04423874 | Recruiting

• 2 other identifiers: 19CH2152020-A00274-35
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

nonverbal vocal communication; babies cries; pain tolerance; cold pressor test

Outcome Measures

Primary Outcomes (1)

• Pain tolerance

  Delay (in seconds) in removing the hand when testing the Cold Pressor.

  at inclusion

Secondary Outcomes (3)

• Onset of pain

  at inclusion

• Pain intensity

  at inclusion

• Correlation between NOL index and video pupillometry results

  at inclusion

Study Arms (1)

Healthy adult population aged 18 to 60 years.

EXPERIMENTAL

Their pain tolerance will be tested using the Cold Pressor Task while listening to vocalisations. Physiological measures will be taken using two techniques: Nociception Level Index and video pupillometry.

Behavioral: Cold pressor task (CPT); Diagnostic Test: index NOL; Behavioral: Playback Experiments; Diagnostic Test: Video-pupillometry

Interventions

Cold pressor task (CPT) BEHAVIORAL

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.

Healthy adult population aged 18 to 60 years.

index NOL DIAGNOSTIC_TEST

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).

Healthy adult population aged 18 to 60 years.

Playback Experiments BEHAVIORAL

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.

Healthy adult population aged 18 to 60 years.

Video-pupillometry DIAGNOSTIC_TEST

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

Healthy adult population aged 18 to 60 years.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Laboratoire ENES-CNPS (Université Lyon/Saint Etienne): collaborator

Study Sites (1)

Centre Hospitalier Universitaire SAINT-ETIENNE

Saint-Etienne, France

RECRUITING

Study Officials

• Roland PEYRON, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland PEYRON, MD

CONTACT

(0)477127805; roland.peyron@chu-st-etienne.fr

Hélène RAINGARD, CRA

CONTACT

(0)4.77.82.97.03; helene.raingard@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 9, 2020
• Study Start: May 25, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)