Randomized Controlled Study Evaluating the Efficacy of Hypnosis in Nuclear Medicine
Randomized Controlled Study Evaluating the Efficacy of Hypnosis by Deportee Method Adapted to Nuclear Medicine
Central Hospital, Nancy, France
100 participants
May 26, 2023
INTERVENTIONAL
Conditions
Summary
In Nuclear Medicine, the examinations are long (20-60 minutes) and the patients must remain immobile, sometimes fasting. The anxiety of the latter can lead to poor quality examinations and sometimes, although already injected with radioactive drugs, the patients refuse the examination. In imaging, the use of hypnosis (prior to the MRI examination or with the patient during a scintigraphic examination) is frequent due to the conformation of MRI or scintigraphic machines, particularly for claustrophobic patients (2-2.5% of cases). Medical electroradiology manipulators (MERM) have been trained to practice Ericksonian hypnosis whose effectiveness in combating anxiety is no longer in question. Scientific studies by Faymonville et al, 2006 and Rainville et al, 2002, have shown the effectiveness of this method in managing anxiety using the simplified STAI-6 scale before and after hypnosis. The dosimetric study of the MERM position would then be greatly modified in favor of a decrease in exposure targeted by the June 4, 2018 decree on personnel safety. The impact of whether or not the MERM is physically present near the patient would also be studied. If minimal, this will resolve the current contradiction between the quality of patient care delivered and the radiation protection imposed in nuclear medicine. The investigators propose here a pilot study evaluating remote-delivered Ericksonian hypnosis versus conventionally-delivered Ericksonian hypnosis, which will allow for the sizing of a subsequent multicenter randomized non-inferiority controlled trial. Indeed, there is currently no data available on the non-inferiority margin of this technique.
Eligibility
Inclusion Criteria6
- Patient referred for a scan or PET scan
- Patient with a score \> 11 on the STAI-6 scale.
- Person, speaking and understanding French
- Having received complete information on the organization of the research and having signed the informed consent
- Age ≥ 18 years, and ≤ 80 years.
- Affiliated with a social security plan.
Exclusion Criteria8
- People who have taken an anxiolytic treatment before going to nuclear medicine.
- Persons referred for a neurological examination.
- People with cognitive or auditory problems, or with a major depressive episode.
- Persons with cardiac rhythm disorders (cardiac arrhythmias)
- Persons who cannot perform the examination for which they need a hypnosis session
- Women of childbearing age who do not have an effective means of contraception
- Person referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code (pregnant woman, parturient or nursing mother, adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice, adult person unable to express his consent).
- Person deprived of liberty by a judicial or administrative decision, subject to psychiatric care under articles L. 3212-1 and L. 3213-1
Interventions
An Ericksonian hypnosis session given to patients during a scintigraphic or PET examination, in a conventional manner, i.e. the hypnotherapist (MERM) is close to the patient in the examination room at the time of the session and communicates with him/her without any special device dedicated to this purpose.
A hypnosis session given to patients during a scintigraphic or PET examination, in a remote manner, i.e. the hypnotherapist (MERM) is in the control room at the time of the session and communicates with the patient via a microphone and the patient has headphones.
Locations(1)
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NCT06116084