The Effect of Nonverbal Vocalisations on Pain Tolerance (VOCPAIN)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Cold pressor task (CPT); Behavioral: Acoustic Recordings; Diagnostic test: Index measurement NOL™; Diagnostic test: Video pupillometry

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.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie PEURIERE, CRA; Phone Number: +33 (0)4.77.82.92.72; Email: marie.peuriere@chu-st-etienne.fr
• Study Contact Backup: Name: Roland PEYRON, MD; Phone Number: +33 (0)477127805; Email: roland.peyron@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France
    • Recruiting
    • CENTRE HOSPITALIER UNIVERSITAIRE Saint-Etienne
    • Principal Investigator: Roland PEYRON, MD
    • Sub-Investigator: Kasia PISANSKI, MD
    • Sub-Investigator: Clément CORNEC, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Healthy adult population aged 18 to 60 years.; Their pain tolerance will be tested using the Cold Pressor Task while producing vocalisations. Produced vocalisations will be audio recorded and physiological measures will be taken using two techniques: Nociception Level Index and video pupillometry.

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 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain tolerance	Delay (in seconds) in removing the hand when testing the Cold Pressor.	at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Subjective assessment of maximum pain intensity by participants for a given trial. Measured by scale of 0 (no pain) at 100 (extreme pain).	at inclusion
Onset of pain	Participant verbally indicates when he or she begins to feel the sensation of pain (time of onset measured in seconds)	at inclusion
correlation between NOL index and pupillary diameter	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.	at inclusion
Analysis of Acoustic Recordings	Using a dedicated script in software specialised in acoustic analysis (e.g. PRAAT).	at inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Laboratoire ENES-CNPS (Université Lyon/Saint Etienne)
• Investigators: Principal Investigator: Roland PEYRON, MD, CHU SAINT-ETIENNE

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: cold pressor test; pain tolerance; nonverbal vocal communication; Nociception Level Index; Video pupillometry
• Other Study ID Numbers: 19CH216; 2020-A00277-32 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No