Randomized Controlled Study Evaluating the Efficacy of Hypnosis in Nuclear Medicine
HYDEM
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started May 2023
Typical duration for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2022
CompletedStudy Start
First participant enrolled
May 26, 2023
CompletedFirst Posted
Study publicly available on registry
November 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedNovember 3, 2023
October 1, 2023
2.3 years
January 21, 2022
October 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Clinical Efficacy of heart rate
1 year
Clinical Efficacy of respiratory rate
1 year
Process evaluation of the intervention for the subsequent multicenter trial
1 year
Process evaluation of the intervention for the subsequent multicenter trial
1 year
Process evaluation of the intervention for the subsequent multicenter trial
1 year
- +1 more secondary outcomes
Study Arms (2)
Ericksonian hypnosis
ACTIVE COMPARATORAn 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 hypnosis
EXPERIMENTALHypnosis session with headphones and microphones
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nancy Hospital
Vandœuvre-lès-Nancy, 54511, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martine Louis
m.louis2@chru-nancy.fr
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicpal investigator
Study Record Dates
First Submitted
January 21, 2022
First Posted
November 3, 2023
Study Start
May 26, 2023
Primary Completion
September 1, 2025
Study Completion
April 1, 2026
Last Updated
November 3, 2023
Record last verified: 2023-10