NCT05714995 Evaluation of the Therapeutic Approach of Aromatherapy by Olfaction of Essential Oils in Association With Hypnosis in the Management of Patients Followed for Cancer
| NCT ID | NCT05714995 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Intercommunal Creteil |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-04-10 |
| Primary Completion | 2026-10-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 66 participants in total. It began in 2024-04-10 with a primary completion date of 2026-10-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05714995 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05714995 currently recruiting?
Yes, NCT05714995 is actively recruiting participants. Contact the research team at lambert.vadrot@chicreteil.fr for enrollment information.
Where is the NCT05714995 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT05714995 clinical trial?
NCT05714995 is sponsored by Centre Hospitalier Intercommunal Creteil. The trial plans to enroll 66 participants.
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