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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patients Scheduled for Cerebral Arteriography for Diagnostic or Therapeutic Purposes
• Intervention / Treatment: Other: music therapy; Other: aromatherapy

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Déborah LEBEDIEFF; Phone Number: +33 2 32 88 89 90; Email: deborah.lebedieff@chu-rouen.fr
• Study Contact Backup: Name: Magali DUVAL, radiology technician; Phone Number: +33 2 32 88 83 83; Email: magali.duval@chu-rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard care
Experimental: standard care and music therapy	Other: 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.
Experimental: standard care and aromatherapy	Other: 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.
Experimental: standard care ansd music therapy and aromatherapy	Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
influence of aromatherapy and music therapy on the patient's stress when undergoing cerebral arteriography.	blood pressure	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stress	scale :0 : no stress to 10 : a lot of stress	day 1
level of pain	scale : 0 : no pain to 10 : unbearable pain	day 1
hospital anxiety and depression scale	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	day 1
Cumulative X-ray dose (mGy/cm2) received by the patient		day 1

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Magali DUVAL, radiology technician, CHU Rouen

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2020 0428 HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No