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

NCT ID: NCT04423874

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-25
• Study Completion Date: 2026-05-31

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy adult population aged 18 to 60 years.

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.

Group Type: EXPERIMENTAL

Cold pressor task (CPT)

Intervention Type: 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.

index NOL

Intervention Type: 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).

Playback Experiments

Intervention Type: 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.

Video-pupillometry

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratoire ENES-CNPS (Université Lyon/Saint Etienne)

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland PEYRON, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Centre Hospitalier Universitaire SAINT-ETIENNE

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Roland PEYRON, MD

Role: CONTACT

roland.peyron@chu-st-etienne.fr

(0)477127805 ext. +33

Hélène RAINGARD, CRA

Role: CONTACT

helene.raingard@chu-st-etienne.fr

(0)4.77.82.97.03 ext. +33

Other Identifiers

2020-A00274-35

Identifier Type: OTHER

Identifier Source: secondary_id

19CH215

Identifier Type: -

Identifier Source: org_study_id