RecruitingNot ApplicableNCT06116084

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


Sponsor

Central Hospital, Nancy, France

Enrollment

100 participants

Start Date

May 26, 2023

Study Type

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This French study tests whether hypnosis can reduce anxiety in patients who are undergoing nuclear medicine scans (such as PET scans). Medical imaging can be stressful, and this study explores whether hypnosis is an effective, drug-free way to help patients feel calmer during their scan. **You may be eligible if:** - You are between 18 and 80 years old - You are scheduled for a nuclear medicine scan or PET scan - You scored above 11 on the STAI-6 anxiety scale (indicating significant anxiety) - You speak and understand French - You are enrolled in the French social security system **You may NOT be eligible if:** - You took an anti-anxiety medication before your scan - You are being scanned for a neurological condition - You have other conditions that prevent participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREricksonian 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.

OTHERHypnosis

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)

Nancy Hospital

Vandœuvre-lès-Nancy, France

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NCT06116084


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