RecruitingNot Applicable

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

France66 participantsStarted 2024-04-10

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 samples via a central catheter with a percutaneous implantable chamber, with a Huber needle * Peripheral venous samples * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: betwen the baseline and day 17

Trial details

NCT IDNCT05714995

SponsorCentre Hospitalier Intercommunal Creteil

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-10-10

Contact for this trial

Lambert VADROT

0157022675 lambert.vadrot@chicreteil.fr

View on ClinicalTrials.gov More Cancer trials