Virtual Reality to Reduce Intraoperative Anxiety in Vasectomies Under Local Anesthesia

Condition(s) studied

Investigational drug(s) / intervention(s)

Virtual reality: We will use a virtual reality glasses with the 'Lending Moments' program, where patients can experience a sunset on a paradise beach while listening to a soothing voice that guides them through the experience with relaxation and meditation techniques. During this time, we will proceed with the surgical intervention.

Study summary

Vasectomy is an elective and ambulatory surgery, typically performed under local anaesthesia. The most common problem that we have found among patients is the anxiety and the apprehension to face the procedure.

Virtual reality (VR), as a novel tool, is relatively underutilized in such medical context. It has been successfully employed across various medical domains, aiding in the training of surgeons, enhancing procedural planning, and offering psychological support to patients.

This project aims to assess the effectiveness of employing distraction maneuverers, using virtual reality glasses, during the intraoperative period on vasectomy surgery, to mitigate anxiety during the surgical process.

We want to develop a randomized clinical trial, single-centre study with a control group (conventional procedure) and an intervention group (Virtual reality Glasses). Anxiety was measured using cortisol level through a biomarker saliva test, involving pre and post-procedure samples for each patient. Additionally, we used the State-Trait Anxiety Inventory (STAI) pre and post procedure to evaluate the anxiety and the correlation with the cortisol levels, To evaluate the patient's satisfaction with the used of VR glasses a satisfaction survey was developed. The study protocol has received approval from the ethical committee of our institution.

The investigators expect to find statistically significant differences in salivary cortisol levels on postoperative samples to prove that VR helps to have a better experience and reduce the intraoperative anxiety.

Eligibility

Primary outcome measure(s)

• Biomarker — 96 weeks
  Cortisol is a commun stress biomarker used in many studies.
• Psicological Scale — 96 weeks
  We will mesure the intraoperative anxiety

Trial sites (1)

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