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

Not Applicable

Terminated

• Conditions: Idiopathic Overactive Bladder
• Interventions: Device: HyPNOS self-hypnosis mask from DREAMINZZ

• Registration Number: NCT05352945
• Lead Sponsor: Centre Hospitalier de Roubaix

Brief 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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-29
• Study Start: 2022-11-25
• Primary Completion: 2024-05-23
• Study Completion: 2024-06-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interventional arm	HyPNOS self-hypnosis mask from DREAMINZZ	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).

Primary Outcome Measures

Name	Time	Method
Pain felt at the time of the injections	During the botulinum toxin injections	Measured by a Visual Analogue Scale (VAS) rated from 0 to 100 millimetres

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CH de Roubaix; 🇫🇷 Roubaix, France