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

NCT05352945 | Terminated DMC

• 1 other identifier: 2020-004
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Idiopathic Overactive Bladder

Keywords

hypnosis mask; idiopathic overactive bladder; pain; anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Anxiety

  During the botulinum toxin injections

• Pain felt on insertion of the cystoscope

  During insertion of the cystoscope

• Occurrence of complications

  During the 7 days post-procedure

• Success of the 50IU procedure

  At 1 month post-procedure

Study Arms (2)

control arm

NO INTERVENTION

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.

interventional arm

EXPERIMENTAL

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

Interventions

HyPNOS self-hypnosis mask from DREAMINZZ DEVICE

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

interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Roubaix: lead

Study Sites (1)

CH de Roubaix

Roubaix, 59100, France

Location

Related Publications (12)

• 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.

  PMID: 24548148 BACKGROUND

• 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.

  PMID: 19937315 RESULT

• 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.

  PMID: 25662706 RESULT

• 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.

  PMID: 11412210 RESULT

• 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.

  PMID: 21371240 RESULT

• 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.

  PMID: 22036776 RESULT

• 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.

  PMID: 10702067 RESULT

• 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.

  PMID: 24472109 RESULT

• 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.

  PMID: 24286546 RESULT

• 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.

  PMID: 26599994 RESULT

• 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.

  PMID: 31410922 RESULT

• 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.

  PMID: 30280915 RESULT

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• François Pecoux, Doctor

  CH ROUBAIX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding is not possible with the self-hypnosis mask as it emits sounds and lights for its effect.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: November 25, 2022
• Primary Completion: May 23, 2024
• Study Completion: June 25, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)