<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03290261</url>
  </required_header>
  <id_info>
    <org_study_id>16-PP-10</org_study_id>
    <nct_id>NCT03290261</nct_id>
  </id_info>
  <brief_title>Hypnosis as a Therapeutic Tool in Patients With Reccurent Cystitis</brief_title>
  <acronym>HYPNOCYST</acronym>
  <official_title>Hypnosis as a Therapeutic Tool in Patients With Reccurent Cystitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Half of the women present an episode of cystitis once in their lives. A recurrence occurs in&#xD;
      about 20% to 30% of the patients, and half of these patients will make more than 4 episodes&#xD;
      per year, defining recurrent cystitis (CR).&#xD;
&#xD;
      Complications such as pyelonephritis are rare (less than 0.5% of patients in the absence of&#xD;
      underlying complication), however, CRs are responsible for a significant impact on women but&#xD;
      also on society. Pain is at the forefront, but also the fear of not managing pollakiuria,&#xD;
      with its social exclusion. The impact on sexuality is major. The medical circuit imposed on&#xD;
      the patients is long and arduous. The clinical assessment sometimes reveals favorable&#xD;
      factors, variable in pre- or post-menopause, but in the majority of cases, no explanatory&#xD;
      cause can resolve the problem and some authors suggest resignation as a classic reaction to&#xD;
      this problem. The only study on psychological disorders associated with recurrent cystitis&#xD;
      suggests patients who are much more anxious than the average of female.&#xD;
&#xD;
      Hypnotherapy is an old technique, used for care in Western societies for at least two hundred&#xD;
      years. By the word, the practitioner induces in the patient a particular state of&#xD;
      consciousness characterized by an indifference on the outside and a hyper suggestibility.&#xD;
      This &quot;hypnotic&quot; state of consciousness can be used to amplify the patient's internal&#xD;
      resources to fight against anxiety and pain, and to eliminate symptoms.&#xD;
&#xD;
      The physiological mechanisms at work in hypnosis are the subject of recent studies becoming&#xD;
      more and more precise. The results of these studies made it possible to objectify changes in&#xD;
      cerebral functioning related to hypnotic trance.&#xD;
&#xD;
      A report by Inserm of 2015 confirms the effectiveness of this practice in hypnosedation,&#xD;
      hypnoanalgesia and hypnotherapy, particularly in irritable bowel syndrome, although the&#xD;
      methodology to be used in its evaluation is difficult and subjective. The principal&#xD;
      investigator hypothesizes that the symptoms presented in recurrent cystitis (pain, anxiety)&#xD;
      can be improved by hypnotherapy, and that thus the prognosis of this pathology can be totally&#xD;
      modified.&#xD;
&#xD;
      In the absence of any study published in the literature, the investigator propose an&#xD;
      intervention pilot study with minimal risks and constraints monocentric prospective&#xD;
      non-randomized prospectively in 15 patients.&#xD;
&#xD;
      The main objective of this project is to demonstrate that hypnotherapy improves the&#xD;
      psycho-emotional parameters of patients suffering from recurrent cystitis after 3 hypnosis&#xD;
      sessions combined with home exercises performed by the patient. The evaluation will be&#xD;
      carried out during the last session of hypnosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Actual">October 29, 2020</completion_date>
  <primary_completion_date type="Actual">October 29, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>non-randomised, single center, pilote study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Score at HAD Scale</measure>
    <time_frame>Month 3</time_frame>
    <description>Overall score at the HAD scale at the end of treatment ie M3, compared to the initial score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score at Pain evaluation scale</measure>
    <time_frame>Month 3</time_frame>
    <description>Overall score at the Pain evaluation scale at the end of treatment ie M3, compared to the initial score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of HAD scale score</measure>
    <time_frame>Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of Pain evaluation scale score</measure>
    <time_frame>Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Month 12</time_frame>
    <description>Patient satisfaction will be assessed on a simple numerical scale of 1 to 10 at the end of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to manage the symptoms</measure>
    <time_frame>Month 12</time_frame>
    <description>The ability to manage their symptoms sera evaluated by a semantic scale at the end of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexuality evaluation</measure>
    <time_frame>Month 12</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of heath care</measure>
    <time_frame>Month 12</time_frame>
    <description>Consumption of health care compared to the previous year (medical consultations for cystitis, number of laboratory tests, antibiotics or analgesics, work stoppage)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Reccurent Cystitis</condition>
  <arm_group>
    <arm_group_label>Patients with reccurent cystitis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient perform 3 hypnosis sessions</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hypnosis</intervention_name>
    <description>3 hypnosis sessions performed at 4 - 6 weeks apart</description>
    <arm_group_label>Patients with reccurent cystitis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged at least 18 years&#xD;
&#xD;
          -  Affiliated to social security&#xD;
&#xD;
          -  Presenting recurrent cystitis defined by a frequency of more than 4 episodes per year,&#xD;
             and alleging stress, pain, impaired quality of life or anxiety related to this&#xD;
             condition.&#xD;
&#xD;
          -  Available to perform 3 hypnosis sessions of one hour to 4/6 weeks apart and to perform&#xD;
             home task prescriptions (self-hypnosis or hearing of a recorded medium).&#xD;
&#xD;
          -  Having previously been explored according to good practice and informed with the tool&#xD;
             created by the RéSO InfectiO PACA Est, with a 3 months follow-up compared to this&#xD;
             initial consultation.&#xD;
&#xD;
          -  Having signed informed consent.&#xD;
&#xD;
          -  Patient under tutelage, under curatorship, protected by the law&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women (declarative because no theoretical contraindication, but different&#xD;
             care)&#xD;
&#xD;
          -  Other nonpharmacological treatments (acupuncture, cognitive and behavioral therapy,&#xD;
             sophrology ...)&#xD;
&#xD;
          -  Treatment with psychotropic drugs modified for less than six months&#xD;
&#xD;
          -  Severe visceral deficiencies in the previous year.&#xD;
&#xD;
          -  Individual psychiatric pathology&#xD;
&#xD;
          -  Other progressive infectious diseases requiring antibiotic treatments&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Véronique Mondain, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Nice</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Archet</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>June 23, 2023</last_update_submitted>
  <last_update_submitted_qc>June 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03290261
org study id: 16-PP-10
nct id: NCT03290261
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: non-randomised, single center, pilote study
primary purpose: Treatment
masking: None (Open Label)
measure: Score at HAD Scale
time frame: Month 3
description: Overall score at the HAD scale at the end of treatment ie M3, compared to the initial score.
measure: Score at Pain evaluation scale
time frame: Month 3
description: Overall score at the Pain evaluation scale at the end of treatment ie M3, compared to the initial score.
measure: Evolution of HAD scale score
time frame: Month 12
measure: Evolution of Pain evaluation scale score
time frame: Month 12
measure: Patient satisfaction
time frame: Month 12
description: Patient satisfaction will be assessed on a simple numerical scale of 1 to 10 at the end of treatment
measure: Ability to manage the symptoms
time frame: Month 12
description: The ability to manage their symptoms sera evaluated by a semantic scale at the end of treatment
measure: Sexuality evaluation
time frame: Month 12
description: 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.
measure: Consumption of heath care
time frame: Month 12
description: Consumption of health care compared to the previous year (medical consultations for cystitis, number of laboratory tests, antibiotics or analgesics, work stoppage)
arm group label: Patients with reccurent cystitis
arm group type: Experimental
description: Patient perform 3 hypnosis sessions
intervention type: Other
intervention name: Hypnosis
description: 3 hypnosis sessions performed at 4 - 6 weeks apart
arm group label: Patients with reccurent cystitis
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Véronique Mondain, PH
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Nice
facility: 
country: France
responsible party type: Sponsor
mesh term: Cystitis