A study of the effect of handholding combined with virtual reality (HHVR) on pain in patients undergoing transperineal prostate biopsy under local anesthesia: a protocol for a single-center, three-arm randomized controlled clinical trial.

[BACKGROUND] Prostate cancer (PCa) is a prevalent urological malignancy, with a rising incidence. The transperineal prostate biopsy (TPB) is a widely adopted diagnostic procedure for confirming PCa. While traditional pharmacological interventions for pain management during TPB are accessible, their potential to induce gastrointestinal side effects and impair liver and renal function can restrict their clinical application. As a result, there is an escalating demand to delve into innovative nonpharmacological interventions (NPIs) that could potentially improve the management of pain in TPB patients. Among these, virtual reality (VR) has shown significant promise in the alleviation of pain and is currently under investigation for its potential synergistic effects when combined with supportive care practices. This study aims to assess the efficacy of handholding combined with virtual reality (HHVR) in reducing pain and anxiety among TPB patients, in comparison to a single NPI. We hypothesize that this integrated approach could offer superior pain management, potentially enriching the overall healthcare experience for those undergoing TPB.

[METHODS] This study, a single-center, open-label, three-arm randomized controlled clinical trial, plans to enroll 177 patients undergoing their first TPB at a tertiary hospital in Sichuan Province, China. Participants will be randomly allocated to one of three groups: usual care, VR, and HHVR. The primary outcome measure is pain level assessment, with secondary endpoints including anxiety levels and salivary cortisol levels, the latter serving as a biomarker for stress response. Hemodynamic parameters will also be assessed to evaluate the physiological impact of the interventions. The primary analysis will adhere to the intention-to-treat principle, utilizing one-way analysis of variance to compare visual analog scale pain scores. Additionally, the study will examine the correlation between changes in salivary cortisol and patients' self-reported pain levels, aiming to establish an objective metric for pain assessment.

[DISCUSSION] This randomized controlled trial evaluated the therapeutic efficacy of a combined intervention, HHVR, for alleviating pain in patients undergoing TPB. The study also investigated the impact of HHVR on salivary cortisol levels, which are acknowledged as a reliable biomarker of stress-induced pain. Affirmative results would indicate that HHVR is efficacious in not only reducing pain but also diminishing anxiety levels.

[TRIAL REGISTRATION] ClinicalTrials.gov ChiCTR2400084616. Retrospectively registered on 21 May 2024, https://www.chictr.org.cn.