An interventional study of Hypnosis in Reccurent Cystitis, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-26.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Patient perform 3 hypnosis sessions
Other: Hypnosis
3 hypnosis sessions performed at 4 - 6 weeks apart
Score at HAD Scale
Overall score at the HAD scale at the end of treatment ie M3, compared to the initial score.
Time frame: Month 3
Score at Pain evaluation scale
Overall score at the Pain evaluation scale at the end of treatment ie M3, compared to the initial score.
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
Patient satisfaction will be assessed on a simple numerical scale of 1 to 10 at the end of treatment
Time frame: Month 12
Ability to manage the symptoms
The ability to manage their symptoms sera evaluated by a semantic scale at the end of treatment
Time frame: 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.
Time frame: 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)
Time frame: Month 12
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice