Effectiveness of HYPNOsis Masks in the Management of Pain and Anxiety During Botulinum TOXin Injections in the Treatment of Idiopathic Overactive Bladder: a Multicenter Randomized Parallel Group Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Pain felt at the time of the injections
研究概览
简要总结
Monocenter, prospective, randomized, parallel group study (1:1) evaluating the efficacy of self-hypnosis performed by mask on pain and anxiety in patients receiving botulinum toxin injections in the treatment of idiopathic overactive bladder refractory to conventional pharmacological treatment.
Patients will be randomized into two groups before injection:
- Group 1: conventional anesthesia
- Group 2: conventional anesthesia and use of the self-hypnosis mask
At the end of the procedure, the patient will express the pain felt thanks to the VAS (Visual Analog Scale) and will answer a questionnaire of anxiety (STATE-TRAIT Anxiety Inventory).
详细描述
Day 0: 1st consultation for overactive bladder refractory to drug treatment: verification of inclusion and non-inclusion criteria. Proposal of the study to the patient and handing over of the information note relating to the study.
D15: Collection of consent and randomisation - execution of the procedure
Botulinum toxin injection procedure
Control arm: conventional anaesthesia The botulinum toxin injection procedure will be carried out in a standard manner, according to French guidances, and after local anaesthesia as specified below.
For the procedure, the patient will be hospitalised in a urological day hospital. She must have a sterile cytobacteriological exam of urine 10 days before the procedure or be on antibiotics, and must not have any coagulation problems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Blinding is not possible with the self-hypnosis mask as it emits sounds and lights for its effect.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman with non-neurological overactive bladder, confirmed by urodynamic assessment and cystoscopy, having resisted a well-conducted pharmacological treatment (trials of various anticholinergics).
- •Age over 18 years
- •Having understood the study and agreed to participate (signing of informed consent)
- •Beneficiary of a health insurance plan
排除标准
- •Neurological patient: tetraplegic, paraplegic, multiple sclerosis for a reliable pain assessment
- •Patients who have already been injected with botulinum toxin in the treatment of this pathology.
- •Psychiatric pathology at risk of decompensation with self-hypnosis
- •Patients who are difficult to assess because of a psychological disorder that does not allow them to answer questionnaires and pain assessment scales
- •Patients under court protection, guardianship or curatorship
结局指标
主要结局
Pain felt at the time of the injections
时间窗: During the botulinum toxin injections
Measured by a Visual Analogue Scale (VAS) rated from 0 to 100 millimetres
次要结局
- Anxiety(During the botulinum toxin injections)
- Occurrence of complications(During the 7 days post-procedure)
- Pain felt on insertion of the cystoscope(During insertion of the cystoscope)
- Success of the 50IU procedure(At 1 month post-procedure)