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Идёт набор NCT04425395

The Effect of Nonverbal Vocalisations on Pain Tolerance

Без фазы С лечением Healthy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cold pressor task (CPT), Acoustic Recordings, Index measurement NOL™, Video pupillometry.
Кому может быть актуально
Состояния в реестре: Healthy. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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 tria
  • Поведенческое 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.
  • Диагностический тест 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).
  • Диагностический тест 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.

Первичные конечные точки

  • Pain tolerance [Срок оценки: at inclusion]
Вторичные конечные точки (4)
  • Onset of pain [Срок оценки: at inclusion]
  • Pain intensity [Срок оценки: at inclusion]
  • correlation between NOL index and pupillary diameter [Срок оценки: at inclusion]
  • Analysis of Acoustic Recordings [Срок оценки: at inclusion]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Франция · 1 центр
  • Centre Hospitalier Universitaire Saint-Etienne — Saint-Etienne

Идентификаторы

NCT: NCT04425395 · 19CH216 · 2020-A00277-32

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗