Hypnotic Communication To Reduce Anxiety And Pain During Prostate Biopsy (HYCapp)

Plain-language summary

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.

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