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Идёт набор NCT06798155

Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery

Без фазы С лечением Hemorrhoid Anal Fistulas MUSICAL THERAPY Anal Fissure and Fistula

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: Standardized Music Listening Therapy.
Кому может быть актуально
Состояния в реестре: Hemorrhoid, Anal Fistulas, MUSICAL THERAPY, Anal Fissure and Fistula. 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
Reunion
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The study, "Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery," aims to evaluate the impact of preoperative listening to standardized music sequences on postoperative pain in patients undergoing proctologic surgery (for hemorrhoids, fistulas, or anal fissures). This research will assess the influence of preoperative music on postoperative pain management, the use of analgesics after surgery and during the following month, and its effect on the quality of life post-surgery. MUSICO-PROCTO is an interventional, randomized study involving two groups (patients will be randomly assigned to either the music intervention or control group). The study is monocentric, conducted at Clinique Saint Vincent in France, and includes 550 participants. Participants will be followed for 28 days, while the overall study duration will span 28 months. To participate, individuals must: Be aged 18 or older. Be affiliated with a social security system. Provide signed informed consent. Undergo proctologic surgery for hemorrhoids, fistulas, or anal fissures. This study seeks to explore the potential of music as a complementary method to improve postoperative outcomes.

Вмешательства

  • Другое Standardized Music Listening Therapy
    Type of Intervention: Pre- and postoperative listening to standardized music sequences designed specifically for relaxation and pain management. Delivery Method: Sessions are conducted via the Music Care® application, using a tablet and headphones provided during hospitalization. Participants select their preferred music style, tempo, and tracks to tailor the experience to their preferences. Duration and Schedule: Pre-surgery: One 20-minute session in a dedicated room before entering the oper

Первичные конечные точки

  • Pain Intensity (EVA Pain) in the recovery room (SSPI). [Срок оценки: Immediately post-surgery in the recovery room.]
Вторичные конечные точки (9)
  • Successive Pain and Anxiety Scores (EVA Pain and EVA Anxiety) [Срок оценки: From hospitalization to Day 28 post-surgery.]
  • State Anxiety Score (STAI-Y-ETAT) [Срок оценки: From hospitalization to Day 28 post-surgery.]
  • Kess Score [Срок оценки: From hospitalization to Day 28 post-surgery]
  • Total Time in SSPI and Hospitalization Duration [Срок оценки: During the hospital stay.]
  • Total Analgesic Consumption During Hospital Stay [Срок оценки: Measured from hospital admission to hospital discharge, within an estimated time frame of 6 to 24 hours (due to the outpatient nature of the procedure).]
  • Time to Healing [Срок оценки: From surgery to Day 28 post-surgery.]
  • Quality of Life Scores (HEMO-FISS-QoL and EQ5D-5L) [Срок оценки: From hospitalization to Day 28 post-surgery.]
  • Patient Satisfaction [Срок оценки: Immediately post-surgery, upon discharge from SSPI.]
  • Medico-Economic Impact [Срок оценки: During the hospital stay.]

Критерии участия

Критерии включения

  • Male or female, aged over 18 years.
  • Patient who has signed an informed consent form.
  • Patient scheduled to undergo proctological surgery (for hemorrhoids, fistula, or anal fissure) at the participating institution.
  • Must be affiliated with a social security system or be a beneficiary of such a system.
  • Patient must have access to the necessary technical means (smartphone, computer, tablet) to use the Music Care® application.

Критерии исключения

  • Refusal to consent.
  • Patient unable to read, write, or understand French.
  • Vulnerable patient according to Article L1121-6 of the French Public Health Code (CSP).
  • Adult patient under guardianship or curatorship or under legal protection (safeguard of justice).
  • Patient unable to personally give informed consent according to Article L.1121-8 of the CSP or an adult protected by law.
  • Pregnant or breastfeeding women according to Article L1121-5 of the CSP.
  • Patient who has already participated in a study within the last 12 months.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Reunion · 2 центра
  • Clinique Saint Vincent — Saint-Denis
  • Clinique Saint Vincent — Saint-Denis

Идентификаторы

NCT: NCT06798155 · 24.04190.000403

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗