Evaluation of the Therapeutic Approach of Aromatherapy by Olfaction of Essential Oils in Association With Hypnosis in the Management of Patients Followed for Cancer
HYPNO-AROMA
1 other identifier
observational
66
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2023
CompletedFirst Posted
Study publicly available on registry
February 6, 2023
CompletedStudy Start
First participant enrolled
April 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 10, 2026
March 11, 2026
June 1, 2025
2.5 years
January 12, 2023
March 9, 2026
Conditions
Outcome Measures
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
betwen the baseline and day 17
Study Arms (2)
hypnosis
patients in the hypnosis group will perform self-hypnosis sessions
hypnosis with aromatherapy
patients in the hypnosis with aromatherapy group will perform self-hypnosis sessions with inhalation of an essential oil
Interventions
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
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
Eligibility Criteria
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)
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000, France
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2023
First Posted
February 6, 2023
Study Start
April 10, 2024
Primary Completion (Estimated)
October 10, 2026
Study Completion (Estimated)
October 10, 2026
Last Updated
March 11, 2026
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share