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

NCT ID: NCT06425237

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2027-11-04

Brief Summary

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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.

Detailed Description

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Conditions

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Patients Scheduled for Cerebral Arteriography for Diagnostic or Therapeutic Purposes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

standard care and music therapy

Group Type EXPERIMENTAL

music therapy

Intervention Type 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 aromatherapy

Group Type EXPERIMENTAL

aromatherapy

Intervention Type 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 ansd music therapy and aromatherapy

Group Type EXPERIMENTAL

music therapy

Intervention Type 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.

aromatherapy

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Magali DUVAL, radiology technician

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Locations

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CHU de ROUEN

Rouen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Magali DUVAL, radiology technician

Role: CONTACT

+33 2 32 88 83 83

Déborah LEBEDIEFF

Role: CONTACT

+33 2 32 88 89 90

Facility Contacts

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MAgali DUVAL

Role: primary

Other Identifiers

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2020/428/HP

Identifier Type: -

Identifier Source: org_study_id

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