An interventional study of HyPNOS self-hypnosis mask from DREAMINZZ in Idiopathic Overactive Bladder, sponsored by Centre Hospitalier de Roubaix. Terminated at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-10.
Sponsored by Centre Hospitalier de Roubaix · Not applicable, Interventional, and Supportive care
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:
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).
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 8 is below the median of 70 across 2,101 interventional studies indexed under Pain.
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Exclusion Criteria:
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.
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
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
Pain felt at the time of the injections
Measured by a Visual Analogue Scale (VAS) rated from 0 to 100 millimetres
Time frame: During the botulinum toxin injections
Anxiety
Measured by the STAI Forme Y-A which assesses the state of anxiety at a given time
Time frame: 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
Time frame: During insertion of the cystoscope
Occurrence of complications
Hematuria, Acute Urine Retention and Urinary Tract Infection
Time frame: During the 7 days post-procedure
Success of the 50IU procedure
Assessed by the doctor
Time frame: At 1 month post-procedure
Plan to share: No — The database created will remain the property of the Hospital Center of Roubaix. The Hospital Center of Roubaix will carry out the main publication of the research. Once this has been done, the investigating centres that participated in the research can request access to the database for the purpose of secondary publications. If the request is successful, the database will be transmitted securely and completely anonymously to the applicant.
This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier de Roubaix