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

Condition(s) studied

Investigational drug(s) / intervention(s)

hypnosis: The hypnosis session involves the following steps: 1. Preparation for the activation of the hypnotic trance 2. Activation of the hypnotic trance 3. Deepening the hypnotic trance 4. Maintaining hypnotic trance 5. Coming out of the hypnotic trance

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: 1. Preparation for the activation of the hypnotic trance 2. Activation of the hypnotic trance 3. Deepening the hypnotic trance 4. Maintaining hypnotic trance 5. Coming out of the hypnotic trance

Study summary

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

Eligibility

Primary outcome measure(s)

• 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 — betwen the baseline and day 17
  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

Trial sites (1)

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