Clinical trial NCT06425237: Evaluation of the Influence of Aromatherapy and Music Therapy on Stress During the Management of Cerebral Arteriography
Official title: Evaluation of the Influence of Aromatherapy and Music Therapy on Stress During the Management of Cerebral Arteriography
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patients Scheduled for Cerebral Arteriography for Diagnostic or Therapeutic Purposes
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: influence of aromatherapy and music therapy on the patient's stress when undergoing cerebral arteriography.
timeFrame: day 1
Secondary outcomes:
measure: stress
timeFrame: day 1
measure: level of pain
timeFrame: day 1
measure: hospital anxiety and depression scale
timeFrame: day 1
measure: Cumulative X-ray dose (mGy/cm2) received by the patient
timeFrame: day 1
Other outcomes:
Locations:
Study officials:
affiliation: CHU Rouen
name: Magali DUVAL, radiology technician
role: PRINCIPAL_INVESTIGATOR
References: