Clinical trial NCT05352945: Effectiveness of HYPNOsis Masks During Botulinum TOXin Injections in Idiopathic Overactive Bladder(HypnoTox)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Idiopathic Overactive Bladder
Keywords: hypnosis mask
idiopathic overactive bladder
pain
anxiety
Lead sponsor: Centre Hospitalier de Roubaix
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain felt at the time of the injections
timeFrame: During the botulinum toxin injections
Secondary outcomes:
measure: Anxiety
timeFrame: During the botulinum toxin injections
measure: Pain felt on insertion of the cystoscope
timeFrame: During insertion of the cystoscope
measure: Occurrence of complications
timeFrame: During the 7 days post-procedure
measure: Success of the 50IU procedure
timeFrame: At 1 month post-procedure
Other outcomes:
Locations:
city: Roubaix
country: France
facility: CH de Roubaix
Study officials:
affiliation: CH ROUBAIX
name: François Pecoux, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang ZS, Wang XL, Xu CL, Zhang C, Cao Z, Xu WD, Wei RC, Sun YH. Music reduces panic: an initial study of listening to preferred music improves male patient discomfort and anxiety during flexible cystoscopy. J Endourol. 2014 Jun;28(6):739-44. doi: 10.1089/end.2013.0705. Epub 2014 Mar 31.
citation: Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
citation: Game X, Karsenty G, Ruffion A, Amarenco G, Ballanger P, Chartier-Kastler E, Cosson M, Costa P, Fatton B, Deffieux X, Haab F, Hermieu JF, Le Normand L, Saussine C, Denys P. [Idiopathic overactive bladder and BOTOX((R)): Literature review]. Prog Urol. 2015 Jun;25(8):461-73. doi: 10.1016/j.purol.2015.01.006. Epub 2015 Feb 3. French.
citation: Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001 Jun;87(9):760-6. doi: 10.1046/j.1464-410x.2001.02228.x.
citation: Coyne KS, Sexton CC, Kopp ZS, Ebel-Bitoun C, Milsom I, Chapple C. The impact of overactive bladder on mental health, work productivity and health-related quality of life in the UK and Sweden: results from EpiLUTS. BJU Int. 2011 Nov;108(9):1459-71. doi: 10.1111/j.1464-410X.2010.10013.x. Epub 2011 Mar 3.
citation: Denys P, Le Normand L, Ghout I, Costa P, Chartier-Kastler E, Grise P, Hermieu JF, Amarenco G, Karsenty G, Saussine C, Barbot F; VESITOX study group in France. Efficacy and safety of low doses of onabotulinumtoxinA for the treatment of refractory idiopathic overactive bladder: a multicentre, double-blind, randomised, placebo-controlled dose-ranging study. Eur Urol. 2012 Mar;61(3):520-9. doi: 10.1016/j.eururo.2011.10.028. Epub 2011 Oct 25.
citation: Schurch B, Schmid DM, Stohrer M. Treatment of neurogenic incontinence with botulinum toxin A. N Engl J Med. 2000 Mar 2;342(9):665. doi: 10.1056/NEJM200003023420918. No abstract available.
citation: Karsenty G, Baverstock R, Carlson K, Diaz DC, Cruz F, Dmochowski R, Fulford S, Giannantoni A, Heesakkers J, Kaufmann A, Peyrat L, Thavaseelan J, Dasgupta P. Technical aspects of botulinum toxin type A injection in the bladder to treat urinary incontinence: reviewing the procedure. Int J Clin Pract. 2014 Jun;68(6):731-42. doi: 10.1111/ijcp.12360. Epub 2014 Jan 29.
citation: Hermieu JF, Ballanger P, Amarenco G, Chartier-Kastler E, Cosson M, Costa P, Fatton B, Deffieux X, Denys P, Game X, Haab F, Karsenty G, Le Normand L, Ruffion A, Saussine C. [Guidelines for practical usage of botulinum toxin type A (BoNTA) for refractory idiopathic overactive bladder management]. Prog Urol. 2013 Dec;23(17):1457-63. doi: 10.1016/j.purol.2013.10.006. Epub 2013 Nov 7. French.
citation: Kendrick C, Sliwinski J, Yu Y, Johnson A, Fisher W, Kekecs Z, Elkins G. Hypnosis for Acute Procedural Pain: A Critical Review. Int J Clin Exp Hypn. 2016;64(1):75-115. doi: 10.1080/00207144.2015.1099405.
citation: Noergaard MW, Hakonsen SJ, Bjerrum M, Pedersen PU. The effectiveness of hypnotic analgesia in the management of procedural pain in minimally invasive procedures: A systematic review and meta-analysis. J Clin Nurs. 2019 Dec;28(23-24):4207-4224. doi: 10.1111/jocn.15025. Epub 2019 Sep 3.
citation: Gezginci E, Iyigun E, Kibar Y, Bedir S. Three Distraction Methods for Pain Reduction During Cystoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain, Anxiety, and Satisfaction. J Endourol. 2018 Nov;32(11):1078-1084. doi: 10.1089/end.2018.0491.