CHU de ROUEN
Rouen, 76 000, France
Location status: Recruiting
Location contact
MAgali DUVAL
CONTACT
Recruiting
NCT Number: NCT06425237
Evaluation of the Influence of Aromatherapy and Music Therapy on Stress During the Management of Cerebral Arteriography
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Music Therapy
Otherstandard 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.
Aromatherapy
Otherstandard 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.
Primary outcomes
-
influence of aromatherapy and music therapy on the patient's stress when undergoing cerebral arteriography.
Time frame: day 1
blood pressure
Secondary outcomes
-
stress
Time frame: day 1
scale :0 : no stress to 10 : a lot of stress
-
level of pain
Time frame: day 1
scale : 0 : no pain to 10 : unbearable pain
-
hospital anxiety and depression scale
Time frame: day 1
scale : 0 to 7: no anxiety no depressed and 7 to 10 : probably anxiety ans drepressed more than and 10 : symptomatology of anxiety and depressed
-
Cumulative X-ray dose (mGy/cm2) received by the patient
Time frame: day 1
Study contacts
Contact information is provided by the study sponsor or research team.
Déborah LEBEDIEFF
CONTACT
Magali DUVAL, radiology technician
CONTACT
Sponsors and collaborators
Lead sponsor
University Hospital, Rouen
Other
Registry information
Acronym: HERMES
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- May 22, 2024
- Registry last updated
- Jun 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.