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

Study Overview
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Brief Summary
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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).

Detailed Description
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Day 0: 1st consultation for overactive bladder refractory to drug treatment: verification of inclusion and non-inclusion criteria. Proposal of the study to the patient and handing over of the information note relating to the study. D15: Collection of consent and randomisation - execution of the procedure Botulinum toxin injection procedure Control arm: conventional anaesthesia The botulinum toxin injection procedure will be carried out in a standard manner, according to French guidances, and after local anaesthesia as specified below. For the procedure, the patient will be hospitalised in a urological day hospital. She must have a sterile cytobacteriological exam of urine 10 days before the procedure or be on antibiotics, and must not have any coagulation problems. A local anaesthetic is given 30 minutes before the procedure according national guidances. Experimental arm: conventional anaesthesia and use of the self-hypnosis mask Same procedure as described for the control arm with the addition of the self-hypnosis mask during the procedure: The mask and the headphones are positioned and activated 10 minutes before the procedure, with the program travel to India chosen because it was developed for pain management and of a duration compatible with the procedure (25 minutes). A short presentation acting as a pre-hypnotic speech can introduce the use of the mask on a patient in order to orientate the effects in the desired goal (analgesia, relaxation, etc.). After connecting the mask to the mobile application, the caregiver will set the appropriate program for the treatment, place the mask over the patient's closed eyes, place the headphones over the patient's ears as well and start the session in question. Following the procedure, monitoring in the day hospital and evaluation at 30 minutes of the procedure by a trained nurse, of the pain felt during the insertion of the cystoscope and during the injections by VAS. Completion of the STATE-TRAIT Anxiety Inventory test. D45: Regular monitoring consultation with evaluation of treatment effectiveness. Collection of data concerning complications (haematuria, urine retention and urinary tract infection). Discharge from the study.

Official Title
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Effectiveness of HYPNOsis Masks in the Management of Pain and Anxiety During Botulinum TOXin Injections in the Treatment of Idiopathic Overactive Bladder: a Multicenter Randomized Parallel Group Study.

Conditions
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Idiopathic Overactive Bladder

Intervention / Treatment
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* Device: HyPNOS self-hypnosis mask from DREAMINZZ


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients newly eligible for treatment of idiopathic overactive bladder with botulinum toxin injection will be randomised into two groups before injection: Group 1: conventional anaesthesia Group 2: conventional anaesthesia and use of self-hypnosis mask
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control arm<br>conventional anaesthesia The botulinum toxin injection procedure will be carried out in the standard way, according to the recommendations applicable in France, and after local anaesthesia. | |
| Experimental: interventional arm<br>conventional anaethesia and use of the self-hypnosis mask The mask and the helmet are positioned and activated 10 minutes before the procedure, with the travel to india programme chosen because it was developed for pain management and its duration is compatible with the procedure (25 minutes). | Device: HyPNOS self-hypnosis mask from DREAMINZZ<br>* The use of the HyPNOS self-hypnosis mask from DREAMINZZ allows patients to immerse themselves in a state of self-hypnosis. A Hypnos session is a narrative accompanied by spatialized sounds (3D) and ambiance for an immersive experience. We aim to evaluate the use of the HyPNOS mask in the management of pain and anxiety in botulinum toxin injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain felt at the time of the injections | Measured by a Visual Analogue Scale (VAS) rated from 0 to 100 millimetres | During the botulinum toxin injections | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Measured by the STAI Forme Y-A which assesses the state of anxiety at a given time | During the botulinum toxin injections | 
| Pain felt on insertion of the cystoscope | Measured by a Visual Analogue Scale (VAS) rated from 0 to 100 millimetres | During insertion of the cystoscope | 
| Occurrence of complications | Hematuria, Acute Urine Retention and Urinary Tract Infection | During the 7 days post-procedure | 
| Success of the 50IU procedure | Assessed by the doctor | At 1 month post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, hypnosis mask, idiopathic overactive bladder, anxiety