Randomized Controlled Study Evaluating the Efficacy of Hypnosis in Nuclear Medicine

Cancer Clinical Trial

— HYDEM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06116084
• Other study ID #: 2021PI059
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: October 2023
• Source: Central Hospital, Nancy, France
• Contact: Anne-Sophie Hue
• Phone: +333153475
• Email: a.hue[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cancer
• Myocarditis
• Parkinson

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Nancy Hospital	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in anxiety score	Difference in anxiety score, measured using the STAI-6 score, of patients before and after scintigraphic or PET examination for each method of Ericksonian hypnosis.; The scale is on 11. If the patient has a score lower than 11 he is not anxious, if the score is higher the patient is anxious.	1 year
Secondary	Clinical Efficacy of heart rate	Difference in heart rates (beats/min) of patients before and after scintigraphy or PET scan for each Ericksonian hypnosis method practiced by conventional method.	1 year
Secondary	Clinical Efficacy of respiratory rate	Difference in respiratory rates (number of respiratory movements/min) of patients before and after scintigraphy or PET scan for each Ericksonian hypnosis method	1 year
Secondary	Process evaluation of the intervention for the subsequent multicenter trial	Intervention dose	1 year
Secondary	Process evaluation of the intervention for the subsequent multicenter trial	Fidelity of the intervention to the protocol (by semi-directed interview conducted by a psychologist researcher with the manipulators to explore the hypnotherapist's experience of the session, and by quality criteria for the completion of the hypnosis session) ;	1 year
Secondary	Process evaluation of the intervention for the subsequent multicenter trial	Target attainment (user satisfaction at the end of the examination, and by semi-structured interview conducted by a psychologist researcher to explore the patient's experience of the hypnosis session); adaptation (during semi-structured interviews with the manipulators).	1 year
Secondary	Impact mechanisms	safety (manipulators operational dosimetry readings before and after each hypnosis session (µSv/h)), manipulators satisfaction at the end of each examination, quality criteria for performing the scan.	1 year