Randomized Trial Comparing the Hypnosis Versus Standard Care of Anxiety and Pain in Patients With Brachytherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Anxiety evaluation
研究概览
简要总结
Formal hypnosis is a non-drug technique known to decrease anxiety and pain during the preoperative procedure.
In brachytherapy, the practice of hypnosis has been shown to be feasible and beneficial for patients treated for prostate cancer The goal of the study is to demonstrate the added value of hypnosis during a brachytherapy detachment by improving the comfort of the patient.
The investigators want to evaluate the contribution of hypnosis during brachytherapy detachment by quantifying the anxiety and pain felt by the patient during the procedure.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients ≥ 18 and ≤ 80 years
- •Patients expected to benefit a brachytherapy detachment Under KALINOX® for one of the types of applications described below:
- •Deep interstitial application: anal canal, vagina, vulva
- •Gynecological application: mold, Utrecht® system or Venezia® system
- •Ability to provide written informed consent
- •Patients affiliated to the social security system
排除标准
- •Minor and patients over 80 years old
- •Patients with major hearing loss
- •Patients who had recent ocular surgery with oculiare gas injection.
- •Patients suffering from psychotic disorders, and dementias.
- •Patients who do not understand the French language
- •Patients under guardianship or deprived of liberty
- •Patients with a contraindication to the administration of KALINOX®
研究组 & 干预措施
experimental
patients to benefit from brachytherapy detachment under KALINOX and formal hypnosis
干预措施: Kalinox (Drug)
active comparator
patients to benefit from brachytherapy detachment under KALINOX
干预措施: Kalinox (Drug)
experimental
patients to benefit from brachytherapy detachment under KALINOX and formal hypnosis
干预措施: formal hypnosis (Other)
结局指标
主要结局
Anxiety evaluation
时间窗: 1day
The patient's anxiety will be assessed using the State-Trait Anxiety Inventory scale ("state of anxiety") before premedication (in the bedroom) and immediately after the brachytherapy detachment (in the examination room) during brachytherapy detachment using two care management: standard care versus standard care with formal hypnosis. The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger et al, 1983). The scale include 20 items. Higher scores indicate greater anxiety
次要结局
- Realization of the brachytherapy detachment(1day)
- Time of brachytherapy detachment(1day)
- Anxiety evaluation(1 day)
- Pain evaluation: numeric scale(1 day)
- Patient's perception of the care(1day)