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临床试验/NCT03290261
NCT03290261已完成不适用

Hypnosis as a Therapeutic Tool in Patients With Reccurent Cystitis

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Score at HAD Scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Score at HAD Scale

时间窗: Month 3

Overall score at the HAD scale at the end of treatment ie M3, compared to the initial score.

次要结局

  • Score at Pain evaluation scale(Month 3)
  • Evolution of HAD scale score(Month 12)
  • Evolution of Pain evaluation scale score(Month 12)
  • Sexuality evaluation(Month 12)
  • Consumption of heath care(Month 12)
  • Patient satisfaction(Month 12)
  • Ability to manage the symptoms(Month 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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