Randomized Controlled Study Evaluating the Efficacy of Hypnosis in Nuclear Medicine (HYDEM)

Central Hospital, Nancy, France

Status

Enrolling

Conditions

Alzheimer Disease

Myocarditis

Parkinson

Cancer

Treatments

Other: Ericksonian Hypnosis

Other: Hypnosis

Study type

Interventional

Funder types

Other

Identifiers

NCT06116084

2021PI059

Details and patient eligibility

About

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.

Full description

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 and Rainville have shown the effectiveness of this method in managing anxiety using the simplified STAI-6 scale before and after hypnosis.

During nuclear medicine examinations, the proximity of MERMs to patients to practice conventional hypnosis results in significant exposure to radioactive radiation, which is not compatible with radiation protection guidelines. Some MERMs have been practicing hypnosis for several years, others are reluctant. However, exposure decreases as a function of the decrease in exposure time and the distance to the radioactive source. If the examination time cannot be modified, the distance to the patient could be by using an original method, remote hypnosis using a headset and microphone to provide Ericksonian hypnosis sessions in the same way as those provided in conventional sessions. 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. This pilot study will also allow for extensive documentation of the implementation of the remote hypnosis technique and for any necessary adjustments to the intervention to ensure its feasibility, acceptability, and reproducibility in the subsequent trial.

The hypothesis is that the use of remote-assisted hypnosis in nuclear medicine reduces patient anxiety as much as conventional Ericksonian hypnosis, while limiting the radiation exposure of the MERMs.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Ericksonian hypnosis

Active Comparator group

Description:

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.

Treatment:

Other: Ericksonian Hypnosis

Experimental hypnosis

Experimental group

Description:

Hypnosis session with headphones and microphones

Treatment:

Other: Hypnosis