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

July 9, 2024 updated by: Centre Hospitalier de Roubaix

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.

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Roubaix, France, 59100
        • CH de Roubaix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control arm

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain felt at the time of the injections
Time Frame: During the botulinum toxin 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
Time Frame: During the botulinum toxin injections
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
Time Frame: During 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
Time Frame: During the 7 days post-procedure
Hematuria, Acute Urine Retention and Urinary Tract Infection
During the 7 days post-procedure
Success of the 50IU procedure
Time Frame: At 1 month post-procedure
Assessed by the doctor
At 1 month post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Roubaix

Investigators

  • Principal Investigator: François Pecoux, Doctor, CH Roubaix

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2022

Primary Completion (Actual)

May 23, 2024

Study Completion (Actual)

June 25, 2024

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Idiopathic Overactive Bladder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe