Virtual Reality to Reduce Intraoperative Anxiety in Vasectomies Under Local Anesthesia

NCT06749353 | Not Yet Recruiting

• 1 other identifier: P/23-079/
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety

Keywords

anxiety; biomarkers; cortisol; vasectomy; virtual reality

Outcome Measures

Primary Outcomes (2)

• Biomarker

  Cortisol is a commun stress biomarker used in many studies.

  96 weeks

• Psicological Scale

  We will mesure the intraoperative anxiety

  96 weeks

Secondary Outcomes (3)

• Patient experience

  96 weeks

• Blood preasure

  96 weeks

• Heart rate

  96 weeks

Study Arms (2)

USUAL

NO INTERVENTION

In the control group, we will perform the surgical procedure as usual, without any distraction maneuvers, under local anesthesia.

VIRTUAL REALITY

EXPERIMENTAL

In the study group, we will perform the vasectomy under local anesthesia and provide patients with virtual reality glasses as a distraction technique, aiming to reduce intraoperative anxiety.

Device: Virtual reality

Interventions

Virtual reality DEVICE

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.

VIRTUAL REALITY

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• Age between 20 and 90 years old
• Intervention between 8 am to 12 am.
• Vasectomy under local anesthesia

You may not qualify if:

• Language barrier
• Oncological urological syurgery
• Surgery time superior to 30 minuts
• Intellectual disability
• STAI Trait \> 70%
• Intervention after 12 am

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead

Study Sites (1)

Hospital Univesitari Mútua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Related Publications (1)

• (1) Mallari B, Spaeth EK, Goh HX, Slijepcevic N, Guo Y, Doherty CJ, Yeomans DC, Burns LC. Virtual Reality Distraction for Pain Control During Medical Procedures: A Systematic Review of Randomized Controlled Trials. Clin J Pain. 2019

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Olga Monistrol, RN, MsC, PhD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Claret, Nurse

CONTACT

+34 699259588; mariaclaretgutierrez@gmail.com

Carles Castillo, Urological Doctor

CONTACT

+34649646220; carlescastillo@mutuaterrassa.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PRE POST INTERVENTION STUDY

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)