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

NCT07476547 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-17

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Fondazione del Piemonte per l'Oncologia

    lead OTHER

Principal Investigators

  • Francesca Fidone · FPO-IRCCS Cancer Institute of Candiolo

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-11
Primary Completion
2025-10-16
Completion
2026-02-18

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07476547 on ClinicalTrials.gov