Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies: a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in anxiety score
研究概览
简要总结
The incidence of breast cancer and its mortality are reduced thanks in particular to early detection.
Often performed after a screening test, stereotactic macrobiopsies are used to characterize abnormalities detected on mammography. This anxiety-inducing and painful examination leads to significant physiological and psychological modifications for these women who logically apprehend the realization of this act.
Faced with this observation, investigators wondered what could be done to improve the experience of the patients during this examination.
Investigators were interested in hypnosis because its effectiveness as a complementary practice has been validated by numerous studies with benefits on pain and stress management.
However, today, there are no convincing results confirming which hypnosis method would be the best to manage patients' anxiety and pain during this examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- 否
入选标准
- •aged 18 or over,
- •referred to the medical imaging department of Saint-Joseph hospital for breast macrobiopsy,
- •naive of any hypnosis,
- •having given free, informed and written consent,
- •being affiliated to a social security scheme or beneficiary of such scheme
排除标准
- •having a major hearing loss,
- •suffering from identified mental or psychotic disorders,
- •not understanding the French language,
- •having already had hypnosis practices,
- •having an ongoing pregnancy,
- •being the subject of a safeguard measure
研究组 & 干预措施
Control
control
Preparation in Self-Hypnosis by anchoring
1-hour consultation with a hypnopractor just before the examination
干预措施: Preparation in Self-Hypnosis by anchoring (Behavioral)
Conversational Hypnosis
conversational hypnosis support during the examination by a radiology technician and a radiologist specifically trained
干预措施: Conversational Hypnosis (Behavioral)
Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis
1-hour consultation with a hypnopractor just before the examination and conversational hypnosis support during the examination by a radiology technician and a radiologist specifically trained
干预措施: Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis (Behavioral)
结局指标
主要结局
change in anxiety score
时间窗: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
Score (from 20 to 80) measured on the State-Trait Anxiety Inventory for state anxiety (STAI-Y1), how respondent feels right now, at this moment. Total scores can be categorized into five levels: 1. \> 65 (very high), 2. from 56 to 65 (high), 3. from 46 to 55 (medium), 4. from 36 to 45 (low), 5. \< 35 (very low). Higher scores mean a worse outcome.
次要结局
- staff examination experience(baseline (immediately after the intervention))
- AE/SAE reporting(baseline (during the intervention, immediatly after the intervetion) and at 8 days)
- Amount of nesthetic administered to the patiet during the procedure(baseline (immediately after the intervention))
- Examination duration(baseline (immediately after the intervention))
- change in anxiety score(baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days)
- patient examination experience(baseline (immediately after the intervention))
- change in pain score(baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days)
- anxiety score(baseline (pre-intervention))