Virtual Reality to Reduce Intraoperative Anxiety in Vasectomies Under Local Anesthesia

ConditionAnxiety
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age20-90
SponsorHospital Mutua de Terrassa

About this trial

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 criteria

Qualifiers

Male

Age between 20 and 90 years old

Intervention between 8 am to 12 am.

Vasectomy under local anesthesia

Disqualifiers

Language barrier

Oncological urological syurgery

Surgery time superior to 30 minuts

Intellectual disability

Trial design

Treatments tested in this trial

  • Virtual reality

Treatment groups

148 Participants
are divided into 2 treatment groups

Sponsors and collaborators