Randomized Controlled Study Evaluating the Efficacy of Hypnosis by Deportee Method Adapted to Nuclear Medicine

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Nancy Hospital
RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Anne-Sophie Hue
a.hue@chru-nancy.fr
+333153475
Backup
Véronique Roch
v.roch@chru-nancy.fr
+33383154276
Time Frame
Start Date: 2023-05-26
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 100
Treatments
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
Sponsors
Leads: Central Hospital, Nancy, France

This content was sourced from clinicaltrials.gov