AnxietyNCT06749353
Virtual Reality to Reduce Intraoperative Anxiety in Vasectomies Under Local Anesthesia
A study testing Virtual reality in people with Anxiety, run by Hospital Mutua de Terrassa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years, men only
- Conditions the study is for
- Anxiety
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Age between 20 and 90 years old
- Intervention between 8 am to 12 am.
- Vasectomy under local anesthesia
Who cannot join
- Language barrier
- Oncological urological syurgery
- Surgery time superior to 30 minuts
- Intellectual disability
- STAI Trait > 70%
- Intervention after 12 am
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Univesitari Mútua de Terrassa
Terrassa, Barcelona, 08221
Pilar Arcusa, +34 937365050, parcusa@mutuaterrassa.es
Maria Claret, RN, MsC
About this study
Official title: Distraction Manuever to Reduce Intraoperative Anxiety During Vasectomy Procedure Under Local Anesthesia
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.
Read more
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.
Read the detailed description
Upon arrival at the ambulatory surgery unit (ASU) for a vasectomy, the patient will be informed about the study. If they agree to participate, they will be given an informed consent form to read and sign.
At the ASU, the nurse will record the patient's age and provide the STAI Trait-State scale for completion before entering the operating room. A preoperative saliva sample will be collected to analyze cortisol levels. The patient will be entered into the database and randomized into either the control or intervention group.
Once in the operating room, the patient will be positioned, and a preoperative verification will be performed. The urologist will speak with the patient to provide information, explain the surgery, and confirm the procedure. Heart rate and blood pressure will be recorded. For patients in the intervention group, virtual reality glasses with the "Lending Moments" program will be applied. This program simulates a sunset on a paradisiacal beach while a calming voice guides the patient through relaxation and meditation techniques. The surgical procedure will be performed during this time. Heart rate and blood pressure will be recorded again during the procedure.
Upon completion of the surgery, the patient will be informed and the virtual reality glasses will be removed for patients in the intervention group. The patient will be accompanied to the waiting room, where a postoperative saliva sample will be collected. The patient will be given the STAI State scale and a questionnaire to assess their experience. Heart rate and blood pressure will be recorded postoperatively.
Samples will be sent to the laboratory for processing the same day. Descriptive statistics will be computed, including means (with standard deviations), frequencies, and proportions, according to the variable type at each phase. The Kolmogorov-Smirnov test will be used to assess the normality of quantitative variables. For variables that do not follow a normal distribution, medians (and the 25th and 75th percentiles) will be reported.
For bivariate analysis, Student's t-test or the Mann-Whitney U test will be used for quantitative variables, and the chi-squared test will be used for categorical variables.
- Conditions
- Anxiety
- Being tested
- Virtual reality
- Keywords
- anxiety, biomarkers, cortisol, vasectomy, virtual reality
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker
Cortisol is a commun stress biomarker used in many studies.
Measured: 96 weeks
Psicological Scale
We will mesure the intraoperative anxiety
Measured: 96 weeks
Secondary outcomes (3)
Patient experience
The patient will complete a questionnaire regardind the attention recieved and subjective anxiety percieved. It has 9 questions, where the patient could evaluate the experience lived during the surgery from 1, being a very bad experience, to 10 being better experience possible.
Measured: 96 weeks
Blood preasure
Measured: 96 weeks
Heart rate
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PRE POST INTERVENTION STUDY
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olga Monistrol, RN, MsC, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749353
- Sponsor's protocol ID
- P/23-079/
- Status last verified
- Jan 2025
- First submitted
- 11 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
(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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distraction Manuever to Reduce Intraoperative Anxiety During Vasectomy Procedure Under Local Anesthesia
- ClinicalTrials.gov ID
- NCT06749353
- Acronym / sponsor ID
- P/23-079/
- Conditions
- Anxiety
- Keywords
- anxiety, biomarkers, cortisol, vasectomy, virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Upon arrival at the ambulatory surgery unit (ASU) for a vasectomy, the patient will be informed about the study. If they agree to participate, they will be given an informed consent form to read and sign.
At the ASU, the nurse will record the patient's age and provide the STAI Trait-State scale for completion before entering the operating room. A preoperative saliva sample will be collected to analyze cortisol levels. The patient will be entered into the database and randomized into either the control or intervention group.
Once in the operating room, the patient will be positioned, and a preoperative verification will be performed. The urologist will speak with the patient to provide information, explain the surgery, and confirm the procedure. Heart rate and blood pressure will be recorded. For patients in the intervention group, virtual reality glasses with the "Lending Moments" program will be applied. This program simulates a sunset on a paradisiacal beach while a calming voice guides the patient through relaxation and meditation techniques. The surgical procedure will be performed during this time. Heart rate and blood pressure will be recorded again during the procedure.
Upon completion of the surgery, the patient will be informed and the virtual reality glasses will be removed for patients in the intervention group. The patient will be accompanied to the waiting room, where a postoperative saliva sample will be collected. The patient will be given the STAI State scale and a questionnaire to assess their experience. Heart rate and blood pressure will be recorded postoperatively.
Samples will be sent to the laboratory for processing the same day. Descriptive statistics will be computed, including means (with standard deviations), frequencies, and proportions, according to the variable type at each phase. The Kolmogorov-Smirnov test will be used to assess the normality of quantitative variables. For variables that do not follow a normal distribution, medians (and the 25th and 75th percentiles) will be reported.
For bivariate analysis, Student's t-test or the Mann-Whitney U test will be used for quantitative variables, and the chi-squared test will be used for categorical variables.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PRE POST INTERVENTION STUDY
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Virtual realityIn 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. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male
- Age between 20 and 90 years old
- Intervention between 8 am to 12 am.
- Vasectomy under local anesthesia
Key exclusion criteria (6 listed)
- Language barrier
- Oncological urological syurgery
- Surgery time superior to 30 minuts
- Intellectual disability
- STAI Trait > 70%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityWe 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. | Device | VIRTUAL REALITY |
Primary outcome
Biomarker
Time frame: 96 weeks
Cortisol is a commun stress biomarker used in many studies.
Psicological Scale
Time frame: 96 weeks
We will mesure the intraoperative anxiety
3 secondary outcomes
Patient experience
Time frame: 96 weeks
Blood preasure
Time frame: 96 weeks
Heart rate
Time frame: 96 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Results publication(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
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olga Monistrol, RN, MsC, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Anxiety, run by Hospital Mutua de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Claret, Nurse (+34 699259588, mariaclaretgutierrez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker (time frame: 96 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06749353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.