Evaluation of the Influence of Aromatherapy and Music Therapy on Stress During the Management of Cerebral Arteriography

Обзор

Cerebral arteriography is a reference examination in medical imaging. This examination is performed to allow the diagnosis and therapeutic management of patients with vascular pathologies. It is most often accompanied by a situation of stress, anxiety and apprehension related to the course of the examination or the announcement of the results. These situations generate physiological reactions in patients, making the performance of cerebral arteriography more complex. In order to improve the quality of care for patients undergoing this invasive examination, it is proposed to use two non-medicinal techniques known for their soothing and relaxing properties: aromatherapy and music therapy alone or in combination. These two techniques will help to establish a common thread from the preparation of the patient before the examination to his return to the post-interventional surveillance room.

Вмешательства

• Другое music therapy
  standard patient care in interventional radiology associated with a well-being atmosphere with the implementation of music therapy (soothing sound environment) in the preparation box and in the examination room.
• Другое aromatherapy
  standard patient care in interventional radiology associated with a well being atmosphere with the implementation of aromatherapy (essential oil of Ylang Ylang) in the preparation box and in the examination room.

Первичные конечные точки

• influence of aromatherapy and music therapy on the patient's stress when undergoing cerebral arteriography. [Срок оценки: day 1]

Вторичные конечные точки (4)

• stress [Срок оценки: day 1]
• level of pain [Срок оценки: day 1]
• hospital anxiety and depression scale [Срок оценки: day 1]
• Cumulative X-ray dose (mGy/cm2) received by the patient [Срок оценки: day 1]

Критерии участия

Критерии включения

• Adult (≥ 18 years old)
• Patient who is scheduled for a cerebral arteriography with local anaesthesia
• Patient who capable to read and understand the patient information and consent.
• Patient capable to read and sign the consent form
• Patient with social insurance
• Woman of childbearing age with effective contraception (see WHO definition), postmenopausal woman (≥ 12 months of amenorrhea not induced by therapy)
• Negative urine pregnancy test

Критерии исключения

• Patients who have had a previous cerebral arteriogram
• Patient with allergy to iodinated contrast medium
• Patient with severe renal insufficiency
• Patient requiring sedation and artificial ventilation
• Patient who is deaf and/or hard of hearing
• Patient with a known allergy to essential oils
• Patient with anosmia

• Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship,
• Pregnant or breastfeeding woman

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

Франция · 1 центр

• CHU de ROUEN — Rouen

Идентификаторы

NCT: NCT06425237 · 2020/428/HP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗