Image

Evaluation of the Therapeutic Approach of Aromatherapy by Olfaction of Essential Oils in Association With Hypnosis in the Management of Patients Followed for Cancer

Evaluation of the Therapeutic Approach of Aromatherapy by Olfaction of Essential Oils in Association With Hypnosis in the Management of Patients Followed for Cancer

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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

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.

Eligibility

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 details
    Cancer

NCT05714995

Centre Hospitalier Intercommunal Creteil

2 May 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.