TerminatedNot Applicable

Effectiveness of HYPNOsis Masks During Botulinum TOXin Injections in Idiopathic Overactive Bladder(HypnoTox)

Stopped: insuffisant patient recruyting

France8 participantsStarted 2022-11-25

Plain-language summary

Monocenter, prospective, randomized, parallel group study (1:1) evaluating the efficacy of self-hypnosis performed by mask on pain and anxiety in patients receiving botulinum toxin injections in the treatment of idiopathic overactive bladder refractory to conventional pharmacological treatment. Patients will be randomized into two groups before injection: * Group 1: conventional anesthesia * Group 2: conventional anesthesia and use of the self-hypnosis mask At the end of the procedure, the patient will express the pain felt thanks to the VAS (Visual Analog Scale) and will answer a questionnaire of anxiety (STATE-TRAIT Anxiety Inventory).

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Woman with non-neurological overactive bladder, confirmed by urodynamic assessment and cystoscopy, having resisted a well-conducted pharmacological treatment (trials of various anticholinergics). * Age over 18 years * Having understood the study and agreed to participate (signing of informed consent) * Beneficiary of a health insurance plan Exclusion Criteria: * Neurological patient: tetraplegic, paraplegic, multiple sclerosis for a reliable pain assessment * Patients who have already been injected with botulinum toxin in the treatment of this pathology. * Psychiatric pathology at risk of decompensation with self-hypnosis * Patients who are difficult to assess because of a psychological disorder that does not allow them to answer questionnaires and pain assessment scales * Patients under court protection, guardianship or curatorship

What they're measuring

Pain felt at the time of the injections

Timeframe: During the botulinum toxin injections

Trial details

NCT IDNCT05352945

SponsorCentre Hospitalier de Roubaix

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-23