Randomized Controlled Study Evaluating the Efficacy of Hypnosis in Nuclear Medicine

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06116084
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Central Hospital, Nancy, France
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Martine Louis
Principal Investigator Affiliation [email protected]
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cancer, Myocarditis, Alzheimer Disease, Parkinson
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Ericksonian hypnosis

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.

Experimental: Experimental hypnosis

Hypnosis session with headphones and microphones

Interventions

Other: - Ericksonian Hypnosis

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.

Other: - Hypnosis

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.

Contact a Trial Team

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International Sites

Nancy Hospital, Vandoeuvre les Nancy, France

Status

Recruiting

Address

Nancy Hospital

Vandoeuvre les Nancy, , 54511

Site Contact

Véronique Roch

[email protected]

+333153475

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