Evaluation of the Therapeutic Approach of Aromatherapy by Olfaction of Essential Oils in Association With Hypnosis in the Management of Patients Followed for Cancer (HYPNO-AROMA)

Evaluation of the Therapeutic Approach of Aromatherapy by Olfaction of Essential Oils in Association With Hypnosis in the Care of Patients Followed in Oncology for Cancer Within a Mobile Palliative Care Support Team (EMASP)

Patients having the following gestures (blood test, change of dressing for cancerous lesion and complete toilet in bed) will be identified by the team of the medical oncology department.

During the first contact (V0), the study will be presented to the patients in order to obtain their consent. Anxiety and well-being will be assessed before performing the gesture causing discomfort (gesture No.1). The gesture will then be performed and the patient's comfort will be evaluated after the gesture is performed in order to obtain the starting data for the study.

Patients will be reviewed in consultation according to the time recommended for each type of gesture.

During the second contact V1 (between 1 and 9 days after D0) anxiety and well-being will be assessed before performing the gesture causing discomfort (gesture No.2). Patients will then be randomized. After randomization, the first hypnosis session will be performed at the same time as gesture No. 2 and the patient's comfort will be evaluated after the gesture is performed. The patient will receive the self-hypnosis training on the same day.

A period of 7 ± 2 days will be considered for the learning time of self-hypnosis.

The third contact will take place on day D7+/-2 after V1. During this visit, anxiety and well-being will be assessed before performing the gesture causing discomfort (gesture No.3). Gesture No.3 will be carried out under the effect of self-hypnosis ± aromatherapy and the measurement of comfort will be carried out immediately afterwards

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: hypnosis; Other: Hypnosis with aromatherapy

Detailed Description

Include (V0):

Patients in whom the following procedures must be performed:

• Blood test
• Tumor Lesion Dressing
• Complete toilet in bed will be identified by the team of the medical oncology department. During the first contact (V0), the study will be presented to the patients in order to obtain their consent. After signing the consent and before performing the gesture causing discomfort (gesture No.1), anxiety and well-being will be assessed by the verbal administration of the ESAS scale. The gesture will then be performed and the patient's comfort will be assessed using the ESAS scale after the gesture has been performed in order to obtain the data at the start of the study. An appointment for the V1 visit (between 1 and 9 days after D0) will be set for the next procedure.

First V1 hypnosis session (between 1 and 9 days after D0):

During the second contact at visit V1 (between 1 and 9 days after D0), anxiety and well-being will be assessed before performing the gesture causing discomfort (gesture No.2). Randomization will take place immediately before performing the procedure. After randomization, the first session of hypnosis +/- aromatherapy will be performed at the same time as gesture No. 2 and the patient's comfort will be evaluated after the gesture is performed. During this hypnosis session, the patient will receive self-hypnosis training according to the group they belong to (self-hypnosis vs self-hypnosis + aromatherapy). An appointment for the realization of the next gesture (gesture No.3) will be set for D7 (+/- 2 days after V1). This period of time (7±2 days) will be considered the learning time for self-hypnosis.

Second V2 hypnosis session (D7+-/ 2 days after V1):

The third contact V2 will take place at (D7+/- 2 days after V1). During this visit, anxiety and well-being will be assessed before performing the gesture causing discomfort (gesture No.3). Gesture No.3 will be carried out under the effect of self-hypnosis ± aromatherapy and the measurement of comfort will be carried out immediately afterwards.

• Study Type: Observational
• Enrollment (Estimated): 66

Contacts and Locations

• Study Contact: Name: Lambert Vadrot; Phone Number: 0157022675; Email: lambert.vadrot@chicreteil.fr
• Study Contact Backup: Name: Camille JUNG; Phone Number: 0157022268; Email: camille.jung@chicreteil.fr

Study Locations

• France
  • Créteil, France, 94000
    • Recruiting
    • Centre Hospitalier Intercommunal de Créteil
    • Contact: Lambert Vadrot; Phone Number: 0157022675; Email: lambert.vadrot@chicreteil.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients coming to HDJ or hospitalized in a conventional medical oncology unit, monitored from the 1st line of chemotherapy and taken care of by the mobile palliative care support team (EMASP)

Description

Inclusion Criteria:

• Patients aged ≥18 years
• Patients followed in medical oncology and by the mobile palliative care support team
• From the first line of chemotherapy
• Patient requiring one of the following procedures:
• Blood test
• Change of dressing for cancerous lesion
• Complete toilet in bed
• Patients who have given their consent
• Patient affiliated with a social security scheme

Exclusion Criteria:

• Protected person under guardianship or curatorship,
• Person deprived of liberty
• Person unable to express consent
• Pregnant woman and breastfeeding woman
• History of allergy or intolerance to essential oils
• Patients with cognitive or language disorders that make it impossible to answer the questionnaires
• Psychotic disorders

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
hypnosis; patients in the hypnosis group will perform self-hypnosis sessions	Other: hypnosis; The hypnosis session involves the following steps: Preparation for the activation of the hypnotic trance; Activation of the hypnotic trance; Deepening the hypnotic trance; Maintaining hypnotic trance; Coming out of the hypnotic trance
hypnosis with aromatherapy; patients in the hypnosis with aromatherapy group will perform self-hypnosis sessions with inhalation of an essential oil	Other: Hypnosis with aromatherapy; for patients in the hypnosis with aromatherapy group, before starting the hypnosis session, they will first choose an essential oil among the 5 proposed. They will pour a drop on their wrist then they will rub it and inhale deeply. The hypnosis session involves the following steps: Preparation for the activation of the hypnotic trance; Activation of the hypnotic trance; Deepening the hypnotic trance; Maintaining hypnotic trance; Coming out of the hypnotic trance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in comfort score between the two groups: The comfort score will be evaluated by the French version of the pain scale of the Edmonton Symptom Assessment System	The comfort score will be evaluated by the French version of the pain scale of the Edmonton Symptom Assessment System. The severity of each symptom was rated from 0 to 10 (0 = no symptom, 10 = worst possible intensity	betwen the baseline and day 17

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HYPNO-AROMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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