The Impact Of HYpnotic Communication On Anxiety, Pain And Perception Of Care On Patients Undergoing Prostatic Biopsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Anxiety level
研究概览
简要总结
This single-centre randomized controlled study (HYCapp) will evaluate whether "hypnotic communication" (a structured, non-drug communication technique delivered by health professionals trained in clinical hypnosis) can reduce anxiety and pain and improve the overall care experience in patients undergoing outpatient prostate biopsy.
Participants (adults aged 40 years or older scheduled for prostate biopsy at IRCCS Candiolo) will be randomly assigned 1:1 to:
Intervention group: standard prostate biopsy plus hypnotic communication provided by a trained nurse throughout the patient's pathway on the day of the procedure.
Control group: standard prostate biopsy without hypnotic communication. Local anaesthesia may be used in both groups if clinically needed. The main outcomes are patient-reported anxiety (VAS-A), pain (VAS), and satisfaction with the care experience (Likert scale 1-5), together with vital signs (heart rate and blood pressure). Assessments will be collected before the biopsy while waiting (T0) and within 30 minutes after the biopsy (T1). Additional outcomes include use of analgesic and local anaesthetic drugs, perceived versus actual procedure duration, procedure-related complications (e.g., bleeding, vasovagal reaction, fever), and time to return to usual daily/work activities.
Follow-up will include a telephone call 24-36 hours after the biopsy (T2), a questionnaire completed at home 7 days after the procedure (T3), and a further questionnaire at the visit when the histology result is communicated (approximately 20-30 days after the biopsy, T4).
The study plans to enroll 98 participants over about 1 year. Hypnotic communication is not expected to cause physical health risks; all participants will receive standard clinical care for prostate biopsy.
详细描述
HYCapp is a prospective, single-centre, randomized controlled trial evaluating whether hypnotic communication-a structured, non-pharmacological communication approach delivered by a nurse trained in clinical hypnosis-can improve the peri-procedural experience of adults undergoing outpatient prostate biopsy.
Prostate biopsy is commonly associated with distress and discomfort, even when standard analgesia and local anaesthesia are available. Anxiety may amplify pain perception and worsen the overall experience of care. Hypnotic techniques have shown benefit in other procedural settings by supporting focused attention, reducing anticipatory stress, and promoting coping strategies. This trial aims to generate pragmatic evidence in a real-world urology outpatient pathway.
Participants scheduled for prostate biopsy at IRCCS Candiolo are randomized 1:1 to:
- Standard-of-care biopsy plus hypnotic communication, or
- Standard-of-care biopsy alone. Randomization is performed using a predefined allocation scheme and stratified to balance factors that may influence the patient experience and procedural characteristics (e.g., age, prostate volume, PSA, lesion site, biopsy approach, and previous biopsy history). Due to the nature of the intervention, blinding is not feasible.
Biopsy is performed according to routine practice and guideline-based standards (systematic sampling and/or targeted sampling when clinically indicated). The biopsy approach (transrectal or transperineal) and use of local anaesthesia/analgesics are decided by the clinical team and may occur in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with an indication for outpatient prostate biopsy
- •Age > 40 years
- •Signed informed consent
排除标准
- •Cognitive impairment
- •Chronic pelvic pain syndrome or known perineal neuralgia
研究组 & 干预措施
Hypnotic Communication
Participants undergo routine prostate biopsy and receive hypnotic communication throughout the procedure from a nurse trained in clinical hypnosis
干预措施: Hypnotic Communication (Behavioral)
Routine prostate biopsy alone
Participants undergo routine prostate biopsy according to standard clinical practice without hypnotic communication.
干预措施: Routine Prostate Biopsy (Procedure)
结局指标
主要结局
Anxiety level
时间窗: Before prostate biopsy during the waiting period (T0), within 30 minutes after biopsy (T1), 24 to 36 hours after biopsy (T2), 7 days after biopsy (T3), and at the histology result visit, approximately 20 to 30 days after biopsy (T4).
Anxiety assessed using the Visual Analogue Scale for Anxiety (VAS-A), together with vital parameters including heart rate and blood pressure
次要结局
未报告次要终点