Cancer Clinical Trial
— HYDEMOfficial title:
Randomized Controlled Study Evaluating the Efficacy of Hypnosis by Deportee Method Adapted to Nuclear Medicine
NCT number | NCT06116084 |
Other study ID # | 2021PI059 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 26, 2023 |
Est. completion date | April 1, 2026 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Nancy Hospital | Vandoeuvre les Nancy |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
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 |
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