## Protocol Section
### Identification Module
**NCT ID:** NCT06425237

**Acronym:** HERMES

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 2020 0428 HP
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Rouen
### Status Module
#### Completion Date
**Date:** 2027-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-09
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Rouen

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Patients Scheduled for Cerebral Arteriography for Diagnostic or Therapeutic Purposes

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 224

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** standard care

**Type:** NO_INTERVENTION

#### Arm Group 2

**Intervention Names:**

- Other: music therapy

**Label:** standard care and music therapy

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Other: aromatherapy

**Label:** standard care and aromatherapy

**Type:** EXPERIMENTAL

#### Arm Group 4

**Intervention Names:**

- Other: music therapy

- Other: aromatherapy

**Label:** standard care ansd music therapy and aromatherapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- standard care and music therapy

- standard care ansd music therapy and aromatherapy

**Description:** 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.

**Name:** music therapy

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- standard care and aromatherapy

- standard care ansd music therapy and aromatherapy

**Description:** 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.

**Name:** aromatherapy

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** blood pressure

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

**Time Frame:** day 1

#### Secondary Outcomes

**Description:** scale :0 : no stress to 10 : a lot of stress

**Measure:** stress

**Time Frame:** day 1

**Description:** scale : 0 : no pain to 10 : unbearable pain

**Measure:** level of pain

**Time Frame:** day 1

**Description:** 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

**Measure:** hospital anxiety and depression scale

**Time Frame:** day 1

**Measure:** Cumulative X-ray dose (mGy/cm2) received by the patient

**Time Frame:** day 1

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** magali.duval@chu-rouen.fr

**Name:** Magali DUVAL, radiology technician

**Phone:** +33 2 32 88 83 83

**Role:** CONTACT

**Contact 2:**

**Email:** deborah.lebedieff@chu-rouen.fr

**Name:** Déborah LEBEDIEFF

**Phone:** +33 2 32 88 89 90

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** CHU Rouen

**Name:** Magali DUVAL, radiology technician

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
