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
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
- Prostate Cancer
- Pain Management
- Acupuncture Analgesia
- Prostate Biopsy
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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