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

University Hospital, Rouen

Status: Enrolling

Conditions: Patients Scheduled for Cerebral Arteriography for Diagnostic or Therapeutic Purposes

Treatments: Other: music therapy; Other: aromatherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06425237

2020/428/HP

Details and patient eligibility

About

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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 4 patient groups

standard care

No Intervention group

standard care and music therapy

Experimental group

Treatment:

Other: music therapy

standard care and aromatherapy

Experimental group

Treatment:

Other: aromatherapy

standard care ansd music therapy and aromatherapy

Experimental group

Treatment:

Other: aromatherapy

Other: music therapy