NCT06987071

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Medipol University · Academic / Other
• Sex: Male
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Transperineal prostate biopsy is a standard diagnostic procedure for prostate cancer, often associated with pain and anxiety. Although local anesthesia is commonly used, it may not fully alleviate discomfort, and systemic medications can introduce side effects. Acupuncture, a traditional Chinese medicine technique, has demonstrated potential in managing procedural pain and reducing anxiety across various clinical settings. However, its specific efficacy for transperineal prostate biopsy remains underexplored. This study aims to determine whether acupuncture, administered before the biopsy, can reduce pain, decrease anxiety, and enhance patient satisfaction compared to a sham procedure. Employing a randomized, single-blind design, the trial seeks to minimize bias and generate robust evidence regarding acupuncture's benefits in this context. Participants will be randomly assigned to either the acupuncture group or the sham acupuncture group, with both receiving standard local anesthesia to ensure ethical care. Pain will be assessed using the Visual Analog Scale (VAS) at multiple time points, and anxiety will be measured with the State-Trait Anxiety Inventory (STAI). Additional outcomes include the use of supplementary analgesics, patient satisfaction, and any adverse events associated with the interventions. The study's findings could inform clinical practice by introducing a complementary, non-pharmacological option for pain management during transperineal prostate biopsy, potentially improving patient comfort and reducing reliance on systemic medications. The study protocol has been approved by the Institutional Review Board (IRB) of our hospital, and all participants will provide written informed consent prior to enrollment. Data will be collected and monitored by an independent data manager to ensure accuracy and patient safety.

Conditions

• Prostate Cancer
• Pain Management
• Acupuncture Analgesia
• Prostate Biopsy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-15
• Primary completion: 2025-10-01
• Completion: 2025-10-20
• First posted: 2025-05-23
• Last updated: 2025-11-21

Locations

1 site across 1 country: Turkey (Türkiye)