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Trial Title:
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
Condition:
Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
hypnosis
Description:
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
Arm group label:
hypnosis
Intervention type:
Other
Intervention name:
Hypnosis with aromatherapy
Description:
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
Arm group label:
hypnosis with aromatherapy
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
Detailed description:
Include (V0):
Patients in whom the following procedures must be performed:
- Blood test
- Tumor Lesion Dressing
- 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. After signing the consent and before
performing the gesture causing discomfort (gesture No.1), anxiety and well-being
will be assessed by the verbal administration of the ESAS scale. The gesture will
then be performed and the patient's comfort will be assessed using the ESAS scale
after the gesture has been performed in order to obtain the data at the start of the
study. An appointment for the V1 visit (between 1 and 9 days after D0) will be set
for the next procedure.
First V1 hypnosis session (between 1 and 9 days after D0):
During the second contact at visit V1 (between 1 and 9 days after D0), anxiety and
well-being will be assessed before performing the gesture causing discomfort (gesture
No.2). Randomization will take place immediately before performing the procedure. After
randomization, the first session of hypnosis +/- aromatherapy will be performed at the
same time as gesture No. 2 and the patient's comfort will be evaluated after the gesture
is performed. During this hypnosis session, the patient will receive self-hypnosis
training according to the group they belong to (self-hypnosis vs self-hypnosis +
aromatherapy). An appointment for the realization of the next gesture (gesture No.3) will
be set for D7 (+/- 2 days after V1). This period of time (7±2 days) will be considered
the learning time for self-hypnosis.
Second V2 hypnosis session (D7+-/ 2 days after V1):
The third contact V2 will take place at (D7+/- 2 days 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.
Criteria for eligibility:
Study pop:
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)
Sampling method:
Non-Probability Sample
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 test
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Intercommunal de Créteil
Address:
City:
Créteil
Zip:
94000
Country:
France
Status:
Recruiting
Contact:
Last name:
Lambert Vadrot
Phone:
0157022675
Email:
lambert.vadrot@chicreteil.fr
Start date:
April 10, 2024
Completion date:
October 2024
Lead sponsor:
Agency:
Centre Hospitalier Intercommunal Creteil
Agency class:
Other
Source:
Centre Hospitalier Intercommunal Creteil
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05714995
