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Идёт набор NCT07070986

Randomized, Single-blind Pilot Study Assessing the Effect of Cutaneous RESonance Stimulation SYMPAthetic and Parasympathetic Tone and Anxiety in Patients Admitted for Cardiac Surgery

— Наблюдательное Anxiety

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: RESC, NSCS.
Кому может быть актуально
Состояния в реестре: Anxiety. Базовые параметры: от 18 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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Официальное название

Randomized, Single-blind Pilot Study Assessing the Effect of Cutaneous RESonance Stimulation on SYMPAthetic and Parasympathetic Tone and Anxiety in Patients Admitted for Cardiac Surgery

Обзор

Anxiety is a natural response to stress which peaks just before the surgery procedure. High levels of anxiety can increase postoperative pain and complications. Medicated anxiolysis is no longer recommended, in the absence of proven efficacy. Other interventions to prevent anxiety are required. The autonomic nervous system (ANS), both sympathetic and parasympathetic, determines the response to stress. Anxiety interventions such as hypnosis, massage and relaxation work by modulating ANS tone. The ANS also modulates heart rate. Anxiety can be measured by RR space, from which HRV, high-frequency (HF) and low-frequency (LF) are components respectively linked to the parasympathetic and sympathetic systems. The LF/HF ratio reflects sympathetic dominance if high, and parasympathetic dominance if low. Cutaneous resonance stimulation (RESC) is a manual technique. RESC can diagnose and correct energy imbalances by skin stimulation between two points and thus act on anxiety. We hypothesized that a preoperative RESC session would modify the sympathetic/parasympathetic balance and reduce anxiety in patients admitted for cardiac surgery, compared to patient receiving a sham RESC session: non-specific cutaneous stimulation (NSCS).

Вмешательства

  • Процедура RESC
    If randomized in the RESC group, interventional group, patient will receive a 20 minutes session of cutaneous resonance stimulation before his cardiac surgery. He will be asked to respond to anxiety questionnaire STAI-E and to evaluate his anxiety on a visual analogue scale (VAS) at J-1 (day of inclusion), J0 (day of surgery), and J1 (the day after surgery). During the RESC session, LF/HF ratio, ANI, heart rate, respiratory rate, perfusion index and skin conductance will be monitored.
  • Другое NSCS
    If randomized in the NSCS group, interventional group, patient will receive a 20 minutes session of non-specific cutaneous stimulation before his cardiac surgery. He will be asked to respond to anxiety questionnaire STAI-E and to evaluate his anxiety on a visual analogue scale at J-1 (day of inclusion), J0 (day of surgery), and J1 (the day after surgery) During the NSCS session, LF/HF ratio, ANI, heart rate, respiratory rate, perfusion index and skin conductance will be monitored.

Первичные конечные точки

  • LF/HF ratio variation compared between the groups [Срок оценки: Between the beginning and the end of the RESC/NCS session (20 minutes)]
Вторичные конечные точки (9)
  • Skin conductance variation compared between the groups [Срок оценки: Between the beginning and the end of the RESC/NCS session (20 minutes)]
  • Perfusion index variations compared between the groups. [Срок оценки: Between the beginning and the end of the RESC/NCS session (20 minutes)]
  • Analgesia nociception index compared between the groups [Срок оценки: Between the beginning and the end of the RESC/NCS session (20 minutes)]
  • Anxiety compared between the groups [Срок оценки: After de RESC/NCS session]
  • Morphine use post-surgery compared between the groups [Срок оценки: Day 1]
  • Anxiety compared between the groups [Срок оценки: After de RESC/NCS session]
  • Heart rate variations compared between the groups. [Срок оценки: Between the beginning and the end of the RESC/NCS session (20 minutes)]
  • Blood pressure variations compared between the groups. [Срок оценки: Between the beginning and the end of the RESC/NCS session (20 minutes)]
  • Respiratory rate variations compared between the groups. [Срок оценки: Between the beginning and the end of the RESC/NCS session (20 minutes)]

Критерии участия

Критерии включения

  • Planned cardiac surgery with extracorporeal circulation
  • Pre operatory anxiety : STAI-E score >30 or Visual Analogue Scale Anxiety >6

Критерии исключения

  • Urgent surgery
  • Atrial fibrillation
  • Impossibility to answer to STAI-E or VAS
  • Use of alternative method
  • Use of an alternative method other for anxiety before inclusion
  • Absence of consent
  • Pregnant, breastfeeding women.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Франция · 1 центр
  • Hopitallouis Pradel — Bron

Идентификаторы

NCT: NCT07070986 · 69HCL24_1239

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗