Acupuncture for Analgesia in Transperineal Prostate Biopsy: A Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: Prostate Cancer; Pain Management; Acupuncture Analgesia; Prostate Biopsy

• Registration Number: NCT06987071
• Lead Sponsor: Medipol University

Brief 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study Start: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-10-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 110

Inclusion Criteria

• Indicated for transperineal prostate biopsy (e.g., elevated PSA, abnormal digital rectal exam).
• Willing and able to provide written informed consent.

Exclusion Criteria

• Known allergy or contraindication to acupuncture (e.g., bleeding disorder, needle phobia).
• Requirement for sedation or general anesthesia.
• Previous experience with acupuncture treatment.
• Severe psychiatric disorders or diagnosed anxiety disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Score	Baseline, perioperative, 30 minutes post-biopsy, 2 hours post-biopsy.	Visual Analog Scale (VAS), a 0-10 scale where 0 represents no pain and 10 represents the worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Anxiety Level	before and after 30 minutes of operation	State-Trait Anxiety Inventory (STAI), a validated questionnaire.
Additional Analgesic Use	after biopsy in 8 hours	Type and dose of any additional pain medication required.
Adverse events	peri operative	Any complications related to acupuncture or the biopsy procedure.

Trial Locations

Locations (1)

İstanbul Başakşehir Çam ve sakura City Hospita; 🇹🇷 İstanbul, Turkey