Centre Hospitalier Intercommunal de Créteil
Créteil, 94000, France
Location status: Recruiting
NCT Number: NCT05714995
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
Créteil, 94000, France
Location status: Recruiting
Include (V0):
Patients in whom the following procedures must be performed:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The hypnosis session involves the following steps:
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:
Time frame: betwen the baseline and day 17
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
Contact information is provided by the study sponsor or research team.
Camille JUNG
CONTACT
Lambert VADROT
CONTACT
Centre Hospitalier Intercommunal Creteil
Other
Evaluation of the Therapeutic Approach of Aromatherapy by Olfaction of Essential Oils in Association With Hypnosis in the Care of Patients Followed in Oncology for Cancer Within a Mobile Palliative Care Support Team (EMASP)
Acronym: HYPNO-AROMA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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