Hypnosis as a Therapeutic Tool in Patients With Reccurent Cystitis (HYPNOCYST)
Primary Purpose
Reccurent Cystitis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hypnosis
Sponsored by
About this trial
This is an interventional treatment trial for Reccurent Cystitis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hôpital Archet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with reccurent cystitis
Arm Description
Patient perform 3 hypnosis sessions
Outcomes
Primary Outcome Measures
Score at HAD Scale
Overall score at the HAD scale at the end of treatment ie M3, compared to the initial score.
Secondary Outcome Measures
Score at Pain evaluation scale
Overall score at the Pain evaluation scale at the end of treatment ie M3, compared to the initial score.
Evolution of HAD scale score
Evolution of Pain evaluation scale score
Patient satisfaction
Patient satisfaction will be assessed on a simple numerical scale of 1 to 10 at the end of treatment
Ability to manage the symptoms
The ability to manage their symptoms sera evaluated by a semantic scale at the end of treatment
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.
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)
Full Information
NCT ID
NCT03290261
First Posted
September 7, 2017
Last Updated
June 23, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT03290261
Brief Title
Hypnosis as a Therapeutic Tool in Patients With Reccurent Cystitis
Acronym
HYPNOCYST
Official Title
Hypnosis as a Therapeutic Tool in Patients With Reccurent Cystitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
October 29, 2019 (Actual)
Study Completion Date
October 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reccurent Cystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
non-randomised, single center, pilote study
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with reccurent cystitis
Arm Type
Experimental
Arm Description
Patient perform 3 hypnosis sessions
Intervention Type
Other
Intervention Name(s)
Hypnosis
Intervention Description
3 hypnosis sessions performed at 4 - 6 weeks apart
Primary Outcome Measure Information:
Title
Score at HAD Scale
Description
Overall score at the HAD scale at the end of treatment ie M3, compared to the initial score.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Score at Pain evaluation scale
Description
Overall score at the Pain evaluation scale at the end of treatment ie M3, compared to the initial score.
Time Frame
Month 3
Title
Evolution of HAD scale score
Time Frame
Month 12
Title
Evolution of Pain evaluation scale score
Time Frame
Month 12
Title
Patient satisfaction
Description
Patient satisfaction will be assessed on a simple numerical scale of 1 to 10 at the end of treatment
Time Frame
Month 12
Title
Ability to manage the symptoms
Description
The ability to manage their symptoms sera evaluated by a semantic scale at the end of treatment
Time Frame
Month 12
Title
Sexuality evaluation
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.
Time Frame
Month 12
Title
Consumption of heath care
Description
Consumption of health care compared to the previous year (medical consultations for cystitis, number of laboratory tests, antibiotics or analgesics, work stoppage)
Time Frame
Month 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique Mondain, PH
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Archet
City
Nice
ZIP/Postal Code
06202
Country
France
12. IPD Sharing Statement
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Hypnosis as a Therapeutic Tool in Patients With Reccurent Cystitis
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