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

NCT07476547 | Completed

• 1 other identifier: 004-FPO25
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Pain

Keywords

Prostate biopsy; Hypnotic communication; Procedural anxiety; Procedural pain; Patient experience; Patient satisfaction; anxiety management

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

Hypnotic Communication

EXPERIMENTAL

Participants undergo routine prostate biopsy and receive hypnotic communication throughout the procedure from a nurse trained in clinical hypnosis

Behavioral: Hypnotic Communication

Routine prostate biopsy alone

ACTIVE COMPARATOR

Participants undergo routine prostate biopsy according to standard clinical practice without hypnotic communication.

Procedure: Routine Prostate Biopsy

Interventions

Hypnotic Communication BEHAVIORAL

A trained nurse uses hypnotic communication throughout the biopsy procedure to support the patient and influence anxiety, pain perception, and perception of care

Hypnotic Communication

Routine Prostate Biopsy PROCEDURE

Routine outpatient prostate biopsy performed according to standard practice, using a transrectal or transperineal approach as clinically indicated, with local anaesthesia if required

Routine prostate biopsy alone

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (1)

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

Candiolo, Torino, 10060, Italy

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain; Pain, Procedural; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Francesca Fidone

  FPO-IRCCS Cancer Institute of Candiolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 to either routine prostate biopsy plus hypnotic communication or routine prostate biopsy alone. Stratified randomization will account for age, prostate volume, PSA value, lesion site, biopsy approach (transrectal/transperineal), and previous biopsy history.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: March 11, 2025
• Primary Completion: October 16, 2025
• Study Completion: February 18, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)