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

NCT06425237 | Recruiting

• 1 other identifier: 2020/428/HP
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Scheduled for Cerebral Arteriography for Diagnostic or Therapeutic Purposes

Outcome Measures

Primary Outcomes (1)

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

  blood pressure

  day 1

Secondary Outcomes (4)

• stress

  day 1

• level of pain

  day 1

• hospital anxiety and depression scale

  day 1

• Cumulative X-ray dose (mGy/cm2) received by the patient

  day 1

Study Arms (4)

standard care

NO INTERVENTION

standard care and music therapy

EXPERIMENTAL

Other: music therapy

standard care and aromatherapy

EXPERIMENTAL

Other: aromatherapy

standard care ansd music therapy and aromatherapy

EXPERIMENTAL

Other: music therapy; Other: aromatherapy

Interventions

music therapy OTHER

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.

standard care and music therapy; standard care ansd music therapy and aromatherapy

aromatherapy OTHER

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.

standard care and aromatherapy; standard care ansd music therapy and aromatherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU de ROUEN

Rouen, 76 000, France

RECRUITING

MeSH Terms

Interventions

Music Therapy; Aromatherapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Phytotherapy

Study Officials

• Magali DUVAL, radiology technician

  CHU Rouen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magali DUVAL, radiology technician

CONTACT

+33 2 32 88 83 83; magali.duval@chu-rouen.fr

Déborah LEBEDIEFF

CONTACT

+33 2 32 88 89 90; deborah.lebedieff@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: May 22, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): November 4, 2027
• Study Completion (Estimated): November 4, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

FR (1)