Idiopathic Overactive BladderHypnoToxNCT05352945
Effectiveness of HYPNOsis Masks During Botulinum TOXin Injections in Idiopathic Overactive Bladder(HypnoTox)
A study testing HyPNOS self-hypnosis mask from DREAMINZZ in people with Idiopathic Overactive Bladder, run by Centre Hospitalier de Roubaix at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Idiopathic Overactive Bladder
- What is being tested?
- HyPNOS self-hypnosis mask from DREAMINZZ
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2022to 25 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read the 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.
- Conditions
- Idiopathic Overactive Bladder
- Being tested
- HyPNOS self-hypnosis mask from DREAMINZZ
- Keywords
- hypnosis mask, idiopathic overactive bladder, pain, anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyPNOS self-hypnosis mask from DREAMINZZDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: HyPNOS self-hypnosis mask from DREAMINZZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain felt at the time of the injections
Measured by a Visual Analogue Scale (VAS) rated from 0 to 100 millimetres
Measured: During the botulinum toxin injections
Secondary outcomes (4)
Anxiety
Measured by the STAI Forme Y-A which assesses the state of anxiety at a given time
Measured: 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
Measured: During insertion of the cystoscope
Occurrence of complications
Hematuria, Acute Urine Retention and Urinary Tract Infection
Measured: During the 7 days post-procedure
Success of the 50IU procedure
Assessed by the doctor
Measured: At 1 month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start25 Nov 2022
- Primary completion23 May 2024
- Study completion25 Jun 2024
Why it stopped: insuffisant patient recruyting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Roubaix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Pecoux, Doctor, Principal investigator, CH ROUBAIX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352945
- Sponsor's protocol ID
- 2020-004
- Acronym
- HypnoTox
- Status last verified
- Jul 2024
- First submitted
- 25 Apr 2022
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 24548148Haylen 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.
PubMed 19937315Game 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.
PubMed 25662706Milsom 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.
PubMed 11412210Coyne 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.
PubMed 21371240Denys 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.
PubMed 22036776Schurch 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.
PubMed 10702067Karsenty 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.
PubMed 24472109Hermieu 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.
PubMed 24286546Kendrick 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.
PubMed 26599994Noergaard 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.
PubMed 31410922Gezginci 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.
PubMed 30280915
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05352945
- Acronym / sponsor ID
- HypnoTox / 2020-004
- Conditions
- Idiopathic Overactive Bladder
- Keywords
- hypnosis mask, idiopathic overactive bladder, pain, anxiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insuffisant patient recruyting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier de RoubaixUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: HyPNOS self-hypnosis mask from DREAMINZZconventional 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyPNOS self-hypnosis mask from DREAMINZZThe 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 | Device | interventional arm |
Primary outcome
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
4 secondary outcomes
Anxiety
Time frame: During the botulinum toxin injections
Pain felt on insertion of the cystoscope
Time frame: During insertion of the cystoscope
Occurrence of complications
Time frame: During the 7 days post-procedure
Success of the 50IU procedure
Time frame: At 1 month post-procedure
Results and safety
The study was stopped early (reason given: insuffisant patient recruyting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Background: PubMed 24548148Zhang 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.
- Results publication: PubMed 19937315Haylen 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.
- Results publication: PubMed 25662706Game 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.
- Results publication: PubMed 11412210Milsom 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.
- Results publication: PubMed 21371240Coyne 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.
- Results publication: PubMed 22036776Denys 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.
- Results publication: PubMed 10702067Schurch 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.
- Results publication: PubMed 24472109Karsenty 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.
- Results publication: PubMed 24286546Hermieu 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.
- Results publication: PubMed 26599994Kendrick 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.
- Results publication: PubMed 31410922Noergaard 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.
- Results publication: PubMed 30280915Gezginci 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Pecoux, Doctor principal investigator
CH ROUBAIX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HyPNOS self-hypnosis mask from DREAMINZZ in people with Idiopathic Overactive Bladder, run by Centre Hospitalier de Roubaix at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insuffisant patient recruyting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain felt at the time of the injections (time frame: During the botulinum toxin injections). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05352945, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.