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

ConditionCancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Intercommunal Creteil

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥18 years

Patients followed in medical oncology and by the mobile palliative care support team

From the first line of chemotherapy

Blood samples via a central catheter with a percutaneous implantable chamber, with a Huber needle

Disqualifiers

Protected person under guardianship or curatorship,

Person deprived of liberty

Person unable to express consent

Pregnant woman and breastfeeding woman

Trial 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)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • hypnosis

    Other intervention

    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

    Other intervention

    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

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: hypnosis1 intervention
Group B: hypnosis with aromatherapy1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
betwen the baseline and day 17

Secondary outcomes

Other outcomes

Sponsors and contacts

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