Clinical trial NCT06116084: Randomized Controlled Study Evaluating the Efficacy of Hypnosis in Nuclear Medicine
Official title: Randomized Controlled Study Evaluating the Efficacy of Hypnosis by Deportee Method Adapted to Nuclear Medicine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Myocarditis
Alzheimer Disease
Parkinson
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in anxiety score
timeFrame: 1 year
Secondary outcomes:
measure: Clinical Efficacy of heart rate
timeFrame: 1 year
measure: Clinical Efficacy of respiratory rate
timeFrame: 1 year
measure: Process evaluation of the intervention for the subsequent multicenter trial
timeFrame: 1 year
measure: Process evaluation of the intervention for the subsequent multicenter trial
timeFrame: 1 year
measure: Process evaluation of the intervention for the subsequent multicenter trial
timeFrame: 1 year
measure: Impact mechanisms
timeFrame: 1 year
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: Nancy Hospital
Study officials:
affiliation: m.louis2@chru-nancy.fr
name: Martine Louis
role: PRINCIPAL_INVESTIGATOR
References: