Acupuncture Analgesia, Pain Management, Prostate Biopsy, Prostate Cancer
Conditions
Keywords
acupuncture, prostate cancer, transperineal prostat biopsy, acupuncture anesthesia
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.
Interventions
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.
Superficial needle insertion at non-acupuncture points without stimulation, administered 30 minutes before the biopsy, mimicking the acupuncture procedure without therapeutic intent.
Sponsors
Study design
Intervention model description
This is a randomized, single-blind, parallel-group trial. Participants are randomly assigned in a 1:1 ratio to receive either acupuncture or sham acupuncture 30 minutes prior to transperineal prostate biopsy. Both groups receive standard local anesthesia. Randomization is performed using a computer-generated sequence, and outcome assessors are blinded to group assignments.
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)