HealthyCRYPAINNCT04423874
The Effect of Exposure to Aversive Non-verbal Vocalizations on Pain Tolerance
A study testing Cold pressor task (CPT), index NOL and Playback Experiments in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Humans produce non-verbal vocalizations (shouting, growling, screaming), laughter, ...) in various contexts that are likely to perform biological functions. and important social issues. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cold pressor task (CPT), index NOL and Playback Experiments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2022to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire SAINT-ETIENNE
Saint-Etienne
Roland PEYRON, MD
Kasia PISANSKI, MD
About this study
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.
- Conditions
- Healthy
- Being tested
- Cold pressor task (CPT), index NOL, Playback Experiments, Video-pupillometry
- Keywords
- nonverbal vocal communication, babies cries, pain tolerance, cold pressor test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold pressor task (CPT)Behavioural
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 NOLDiagnostic 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 ExperimentsBehavioural
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-pupillometryDiagnostic test
This technique is based on the observation of the dilatation of the pupil during the perception of a nociceptive stimulus in test persons.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cold pressor task (CPT); Diagnostic Test: index NOL; Behavioral: Playback Experiments; Diagnostic Test: Video-pupillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain tolerance
Delay (in seconds) in removing the hand when testing the Cold Pressor.
Measured: at inclusion
Secondary outcomes (3)
Onset of pain
Participant verbally indicates when he or she begins to feel the sensation of pain (time of onset measured in seconds).
Measured: at inclusion
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).
Measured: at inclusion
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.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start25 May 2022
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire ENES-CNPS (Université Lyon/Saint Etienne)
- Responsible party
- Sponsor
- Investigators
- Roland PEYRON, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423874
- Sponsor's protocol ID
- 19CH215
- Other IDs
- 2020-A00274-35
- Acronym
- CRYPAIN
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2020
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exposure to Aversive Non-verbal Vocalizations on Pain Tolerance
- ClinicalTrials.gov ID
- NCT04423874
- Acronym / sponsor ID
- CRYPAIN / 19CH215
- Conditions
- Healthy
- Keywords
- nonverbal vocal communication, babies cries, pain tolerance, cold pressor test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Laboratoire ENES-CNPS (Université Lyon/Saint Etienne)
- Study start
- 25 May 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adult population aged 18 to 60 years. | Experimental | Behavioral: Cold pressor task (CPT), Diagnostic Test: index NOL, Behavioral: Playback Experiments, Diagnostic Test: Video-pupillometryTheir 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Healthy adult population aged 18 to 60 years. |
| index NOLMeasurement 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). | Diagnostic test | Healthy adult population aged 18 to 60 years. |
| Playback ExperimentsDuring 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. | Behavioural | Healthy adult population aged 18 to 60 years. |
| Video-pupillometryThis technique is based on the observation of the dilatation of the pupil during the perception of a nociceptive stimulus in test persons. | Diagnostic test | Healthy adult population aged 18 to 60 years. |
Primary outcome
Pain tolerance
Time frame: at inclusion
Delay (in seconds) in removing the hand when testing the Cold Pressor.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roland PEYRON, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold pressor task (CPT), index NOL and Playback Experiments in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roland PEYRON, MD ((0)477127805 ext. +33, roland.peyron@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain tolerance (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.