Efficacy Of Acupuncture in Pain and Anxiety During Transperineal Prostate Biopsy: A Prospective, Randomized, Sham-Controlled Trial

NCT06987071 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-11-21

No results posted yet for this study

Summary

This randomized controlled trial evaluates the efficacy of acupuncture in reducing pain and improving patient experience during transperineal prostate biopsy. Participants will be randomized to receive either acupuncture or sham acupuncture prior to the biopsy, in addition to standard local anesthesia. The primary outcome is pain, measured using the Visual Analog Scale (VAS), while secondary outcomes include anxiety, additional analgesic use, patient satisfaction, and adverse events.

Conditions

Interventions

PROCEDURE

Acupuncture

Insertion of sterile, single-use needles at specific acupuncture points (LI4, PC6, ST36, SP6) for 20 minutes with manual stimulation, administered 30 minutes before the biopsy by a licensed acupuncturist.

PROCEDURE

sham acupuncture

Superficial needle insertion at non-acupuncture points without stimulation, administered 30 minutes before the biopsy, mimicking the acupuncture procedure without therapeutic intent.

Sponsors & Collaborators

  • Medipol University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2025-10-01
Completion
2025-10-20

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

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 NCT06987071 on ClinicalTrials.gov