跳至主要内容
临床试验/NCT06425237
NCT06425237招募中不适用

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

University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2024年11月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
224
试验地点
2
主要终点
influence of aromatherapy and music therapy on the patient's stress when undergoing cerebral arteriography.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

standard care

No Intervention

standard care and aromatherapy

Experimental

干预措施: aromatherapy (Other)

standard care ansd music therapy and aromatherapy

Experimental

干预措施: music therapy (Other)

standard care ansd music therapy and aromatherapy

Experimental

干预措施: aromatherapy (Other)

standard care and music therapy

Experimental

干预措施: music therapy (Other)

结局指标

主要结局

influence of aromatherapy and music therapy on the patient's stress when undergoing cerebral arteriography.

时间窗: day 1

blood pressure

次要结局

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

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (2)

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