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

The Impact Of HYpnotic Communication On Anxiety, Pain And Perception Of Care On Patients Undergoing Prostatic Biopsy: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety
• Intervention / Treatment: Behavioral: Hypnotic Communication; Procedure: Routine Prostate Biopsy

Detailed Description

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.

The operational difference between groups concerns patient support and communication during the procedure:

In the intervention arm, a nurse trained in clinical hypnosis provides hypnotic communication throughout the care pathway on the day of biopsy (arrival, preparation, procedure, and immediate observation), using structured language and attention/imagery techniques; where appropriate, an anchoring phase may be used to facilitate persistence of wellbeing after the procedure, followed by re-orientation.

In the control arm, monitoring and support are provided as per standard practice by staff without hypnotic communication.

Assessments are collected at standardized timepoints: pre-procedure (baseline anxiety/stress-related measures and vital signs), immediately post-procedure (patient-reported experience measures, vital signs, documentation of medications used, perceived vs actual procedure duration, and immediate events), and during follow-up (24-36 hours by telephone, 7 days by questionnaire, and at the visit when histology results are communicated, approximately 20-30 days after biopsy). Follow-up is conducted by staff not trained as clinical hypnologists.

The planned sample size is 98 participants. Analyses will compare groups on changes over time in patient-reported experience and physiological measures, using appropriate statistical methods based on data distribution and accounting for relevant procedural covariates.

All participants receive standard clinical care. Hypnotic communication is not expected to introduce physical health risks and is intended to improve comfort and perceived quality of care during and after the biopsy. Data are handled according to applicable ethical and privacy requirements.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Torino
    • Candiolo, Torino, Italy, 10060
      • Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults with an indication for outpatient prostate biopsy
• Age > 40 years
• Signed informed consent

Exclusion Criteria:

• Cognitive impairment
• Chronic pelvic pain syndrome or known perineal neuralgia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnotic Communication; Participants undergo routine prostate biopsy and receive hypnotic communication throughout the procedure from a nurse trained in clinical hypnosis	Behavioral: Hypnotic Communication; A trained nurse uses hypnotic communication throughout the biopsy procedure to support the patient and influence anxiety, pain perception, and perception of care
Active Comparator: Routine prostate biopsy alone; Participants undergo routine prostate biopsy according to standard clinical practice without hypnotic communication.	Procedure: Routine Prostate Biopsy; Routine outpatient prostate biopsy performed according to standard practice, using a transrectal or transperineal approach as clinically indicated, with local anaesthesia if required

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety level	Anxiety assessed using the Visual Analogue Scale for Anxiety (VAS-A), together with vital parameters including heart rate and blood pressure	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).

Collaborators and Investigators

• Sponsor: Fondazione del Piemonte per l'Oncologia
• Investigators: Principal Investigator: Francesca Fidone, FPO-IRCCS Cancer Institute of Candiolo

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2025
• Primary Completion (Actual): October 16, 2025
• Study Completion (Actual): February 18, 2026

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Patient satisfaction; Prostate biopsy; Procedural pain; Procedural anxiety; Patient experience; anxiety management; Hypnotic communication
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Pain, Procedural; Pain; Anxiety Disorders; Patient Satisfaction
• Other Study ID Numbers: 004-FPO25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No