Reccurent CystitisHYPNOCYSTNCT03290261
Hypnosis as a Therapeutic Tool in Patients With Reccurent Cystitis
A study testing Hypnosis in people with Reccurent Cystitis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Half of the women present an episode of cystitis once in their lives. A recurrence occurs in about 20% to 30% of the patients, and half of these patients will make more than 4 episodes per year, defining recurrent cystitis (CR). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Reccurent Cystitis
- What is being tested?
- Hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2017to 29 Oct 2020
- 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
- Women aged at least 18 years
- Affiliated to social security
- Presenting recurrent cystitis defined by a frequency of more than 4 episodes per year, and alleging stress, pain, impaired quality of life or anxiety related to this condition.
- Available to perform 3 hypnosis sessions of one hour to 4/6 weeks apart and to perform home task prescriptions (self-hypnosis or hearing of a recorded medium).
- Having previously been explored according to good practice and informed with the tool created by the RéSO InfectiO PACA Est, with a 3 months follow-up compared to this initial consultation.
- Having signed informed consent.
- Patient under tutelage, under curatorship, protected by the law
Who cannot join
- Pregnant women (declarative because no theoretical contraindication, but different care)
- Other nonpharmacological treatments (acupuncture, cognitive and behavioral therapy, sophrology ...)
- Treatment with psychotropic drugs modified for less than six months
- Severe visceral deficiencies in the previous year.
- Individual psychiatric pathology
- Other progressive infectious diseases requiring antibiotic treatments
Trial locations and contacts
1 site in 1 country.
About this study
Half of the women present an episode of cystitis once in their lives. A recurrence occurs in about 20% to 30% of the patients, and half of these patients will make more than 4 episodes per year, defining recurrent cystitis (CR).
Complications such as pyelonephritis are rare (less than 0.5% of patients in the absence of underlying complication), however, CRs are responsible for a significant impact on women but also on society. Pain is at the forefront, but also the fear of not managing pollakiuria, with its social exclusion. The impact on sexuality is major. The medical circuit imposed on the patients is long and arduous. The clinical assessment sometimes reveals favorable factors, variable in pre- or post-menopause, but in the majority of cases, no explanatory cause can resolve the problem and some authors suggest resignation as a classic reaction to this problem. The only study on psychological disorders associated with recurrent cystitis suggests patients who are much more anxious than the average of female.
Read more
Hypnotherapy is an old technique, used for care in Western societies for at least two hundred years. By the word, the practitioner induces in the patient a particular state of consciousness characterized by an indifference on the outside and a hyper suggestibility. This "hypnotic" state of consciousness can be used to amplify the patient's internal resources to fight against anxiety and pain, and to eliminate symptoms.
The physiological mechanisms at work in hypnosis are the subject of recent studies becoming more and more precise. The results of these studies made it possible to objectify changes in cerebral functioning related to hypnotic trance.
A report by Inserm of 2015 confirms the effectiveness of this practice in hypnosedation, hypnoanalgesia and hypnotherapy, particularly in irritable bowel syndrome, although the methodology to be used in its evaluation is difficult and subjective. The principal investigator hypothesizes that the symptoms presented in recurrent cystitis (pain, anxiety) can be improved by hypnotherapy, and that thus the prognosis of this pathology can be totally modified.
In the absence of any study published in the literature, the investigator propose an intervention pilot study with minimal risks and constraints monocentric prospective non-randomized prospectively in 15 patients.
The main objective of this project is to demonstrate that hypnotherapy improves the psycho-emotional parameters of patients suffering from recurrent cystitis after 3 hypnosis sessions combined with home exercises performed by the patient. The evaluation will be carried out during the last session of hypnosis.
- Conditions
- Reccurent Cystitis
- Being tested
- Hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisOther
3 hypnosis sessions performed at 4 - 6 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Patients with reccurent cystitis | Experimental | Patient perform 3 hypnosis sessions Receives: Other: Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score at HAD Scale
Overall score at the HAD scale at the end of treatment ie M3, compared to the initial score.
Measured: Month 3
Secondary outcomes (7)
Score at Pain evaluation scale
Overall score at the Pain evaluation scale at the end of treatment ie M3, compared to the initial score.
Measured: Month 3
Evolution of HAD scale score
Measured: Month 12
Evolution of Pain evaluation scale score
Measured: Month 12
Patient satisfaction
Patient satisfaction will be assessed on a simple numerical scale of 1 to 10 at the end of treatment
Measured: Month 12
Ability to manage the symptoms
The ability to manage their symptoms sera evaluated by a semantic scale at the end of treatment
Measured: Month 12
Sexuality evaluation
Assessment of the performance in charge of sexuality serum evaluation of the overall semantic scale and on the specific improvement of 2 criteria: anxiety of the sexual act, comfort (dyspareunia) during the act.
Measured: Month 12
Consumption of heath care
Consumption of health care compared to the previous year (medical consultations for cystitis, number of laboratory tests, antibiotics or analgesics, work stoppage)
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start8 Aug 2017
- Primary completion29 Oct 2019
- Study completion29 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reccurent CystitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non-randomised, single center, pilote study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique Mondain, PH, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290261
- Sponsor's protocol ID
- 16-PP-10
- Acronym
- HYPNOCYST
- Status last verified
- Jun 2023
- First submitted
- 7 Sep 2017
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis as a Therapeutic Tool in Patients With Reccurent Cystitis
- ClinicalTrials.gov ID
- NCT03290261
- Acronym / sponsor ID
- HYPNOCYST / 16-PP-10
- Conditions
- Reccurent Cystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 21 Sep 2017 (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.
Half of the women present an episode of cystitis once in their lives. A recurrence occurs in about 20% to 30% of the patients, and half of these patients will make more than 4 episodes per year, defining recurrent cystitis (CR).
Complications such as pyelonephritis are rare (less than 0.5% of patients in the absence of underlying complication), however, CRs are responsible for a significant impact on women but also on society. Pain is at the forefront, but also the fear of not managing pollakiuria, with its social exclusion. The impact on sexuality is major. The medical circuit imposed on the patients is long and arduous. The clinical assessment sometimes reveals favorable factors, variable in pre- or post-menopause, but in the majority of cases, no explanatory cause can resolve the problem and some authors suggest resignation as a classic reaction to this problem. The only study on psychological disorders associated with recurrent cystitis suggests patients who are much more anxious than the average of female.
Hypnotherapy is an old technique, used for care in Western societies for at least two hundred years. By the word, the practitioner induces in the patient a particular state of consciousness characterized by an indifference on the outside and a hyper suggestibility. This "hypnotic" state of consciousness can be used to amplify the patient's internal resources to fight against anxiety and pain, and to eliminate symptoms.
The physiological mechanisms at work in hypnosis are the subject of recent studies becoming more and more precise. The results of these studies made it possible to objectify changes in cerebral functioning related to hypnotic trance.
A report by Inserm of 2015 confirms the effectiveness of this practice in hypnosedation, hypnoanalgesia and hypnotherapy, particularly in irritable bowel syndrome, although the methodology to be used in its evaluation is difficult and subjective. The principal investigator hypothesizes that the symptoms presented in recurrent cystitis (pain, anxiety) can be improved by hypnotherapy, and that thus the prognosis of this pathology can be totally modified.
In the absence of any study published in the literature, the investigator propose an intervention pilot study with minimal risks and constraints monocentric prospective non-randomized prospectively in 15 patients.
The main objective of this project is to demonstrate that hypnotherapy improves the psycho-emotional parameters of patients suffering from recurrent cystitis after 3 hypnosis sessions combined with home exercises performed by the patient. The evaluation will be carried out during the last session of hypnosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-randomised, single center, pilote study
| Arm | Type | Receives |
|---|---|---|
| Patients with reccurent cystitis | Experimental | Other: HypnosisPatient perform 3 hypnosis sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged at least 18 years
- Affiliated to social security
- Presenting recurrent cystitis defined by a frequency of more than 4 episodes per year, and alleging stress, pain, impaired quality of life or anxiety related to this condition.
- Available to perform 3 hypnosis sessions of one hour to 4/6 weeks apart and to perform home task prescriptions (self-hypnosis or hearing of a recorded medium).
- Having previously been explored according to good practice and informed with the tool created by the RéSO InfectiO PACA Est, with a 3 months follow-up compared to this initial consultation.
Key exclusion criteria (6 listed)
- Pregnant women (declarative because no theoretical contraindication, but different care)
- Other nonpharmacological treatments (acupuncture, cognitive and behavioral therapy, sophrology ...)
- Treatment with psychotropic drugs modified for less than six months
- Severe visceral deficiencies in the previous year.
- Individual psychiatric pathology
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 |
|---|---|---|
| Hypnosis3 hypnosis sessions performed at 4 - 6 weeks apart | Other | Patients with reccurent cystitis |
Primary outcome
Score at HAD Scale
Time frame: Month 3
Overall score at the HAD scale at the end of treatment ie M3, compared to the initial score.
7 secondary outcomes
Score at Pain evaluation scale
Time frame: Month 3
Evolution of HAD scale score
Time frame: Month 12
Evolution of Pain evaluation scale score
Time frame: Month 12
Patient satisfaction
Time frame: Month 12
Ability to manage the symptoms
Time frame: Month 12
Sexuality evaluation
Time frame: Month 12
Consumption of heath care
Time frame: Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
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.
Véronique Mondain, PH principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Reccurent Cystitis, run by Centre Hospitalier Universitaire de Nice 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 26 Jun 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score at HAD Scale (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2023.