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RecruitingNCT04423874CRYPAINUpdated Jul 1, 2025

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

An interventional study of Cold pressor task (CPT) and index NOL in Healthy, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 1 site in France. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-01.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started May 2022; still recruiting 4 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • nonverbal vocal communication
  • babies cries
  • pain tolerance
  • cold pressor test
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
104 participants (estimated)

Study arms

  • Experimental
    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.

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

Interventions

  • BehavioralCold 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.

  • Diagnostic testindex 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).

  • BehavioralPlayback 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 testVideo-pupillometry

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

06

What researchers measure

Primary outcomes

  1. Pain tolerance

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

    Time frame: at inclusion

Secondary outcomes

  1. Onset of pain

    Participant verbally indicates when he or she begins to feel the sensation of pain (time of onset measured in seconds).

    Time frame: at inclusion

  2. 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).

    Time frame: at inclusion

  3. Correlation between NOL index and video pupillometry results

    Measurement of the NOL index (index ranging from 0 to 100) and measurement of pupillary diameter and its variations (in mm) in response to nociceptive stimuli by video pupillometry.

    Time frame: at inclusion

07

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier Universitaire SAINT-ETIENNE
    Saint-Etienne, France
    • Roland PEYRON, MD · Principal investigator
    • Kasia PISANSKI, MD · Sub investigator
    • Clément CORNEC, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04423874
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Laboratoire ENES-CNPS (Université Lyon/Saint Etienne)
Responsible party
Sponsor
First posted
Jun 9, 2020
Start date
May 25, 2022
Primary completion
May 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Jul 1, 2025

Study contacts

Roland PEYRON, MD
Contact
roland.peyron@chu-st-etienne.fr
(0)477127805 ext. +33
Hélène RAINGARD, CRA
Contact
helene.raingard@chu-st-etienne.fr
(0)4.77.82.97.03 ext. +33
Roland PEYRON, MD
principal investigator · Centre Hospitalier Universitaire de Saint Etienne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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