Virtual RealityNCT07014267
Virtual Reality for Mindfulness and Anxiety Reduction in Fertility Procedures
A study testing Intervention Group (Virtual Reality intervention) in people with Virtual Reality and Patient Experience, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial summary
This study aims to evaluate the effectiveness of a Virtual Reality (VR)-based mindfulness and meditation intervention in reducing anxiety among patients undergoing fertility-related surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Patient Experience
- What is being tested?
- Intervention Group (Virtual Reality intervention)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 10 Jul 2025to 31 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-50.
- Scheduled for fertility-related surgical procedures.
- Able to provide informed consent.
Who cannot join
- History of motion sickness or VR-related discomfort.
- Cognitive or psychological conditions affecting participation.
- Procedures requiring emergency intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site, 1 recruiting
- Recruiting
ART Fertility Clinics LLC
Abu Dhabi
Jonalyn, Research Coordinator, +97126528000, jonalyn.edades@artfertilityclinics.com
Barbara Lawrenz, Research Director, +97126528000, barbara.lawrenz@artfertilityclinics.com
About this study
This study aims to evaluate the effectiveness of a Virtual Reality (VR)-based mindfulness and meditation intervention in reducing anxiety among patients undergoing fertility-related surgical procedures. Anxiety is a common challenge in fertility treatments, often leading to emotional distress and increased pain perception. By incorporating a non-invasive VR intervention, the investigators seek to improve patient experience, minimize preoperative anxiety, and potentially reduce postoperative discomfort and recovery times. This randomized controlled trial (RCT) will compare standard care with a VR intervention in a clinical setting, measuring key outcomes such as anxiety levels, pain perception, recovery duration, and overall patient satisfaction. The findings may contribute to more patient centered fertility care, offering an innovative, scalable, and cost-effective approach to anxiety management in reproductive medicine.
Read the detailed description
This study examines the effectiveness of a Virtual Reality (VR) mindfulness intervention in reducing anxiety for patients undergoing fertility surgeries. The trial will compare VR with standard care, measuring outcomes like anxiety, pain, recovery time, and patient satisfaction. The results could provide a cost-effective, patient-centered approach to managing anxiety in fertility treatments.
- Conditions
- Virtual Reality, Patient Experience
- Being tested
- Intervention Group (Virtual Reality intervention)
- Keywords
- anxiety, stress, pain perception, recovery duration, 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.
Intervention Group (Virtual Reality intervention)Device
Patients will experience the VR mindfulness intervention using the Tripp App or comparable applications.
Anxiety levels will be measured using the STAI before the VR experience, immediately after the VR experience, and after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (No VR intervention) | No intervention | Patients will receive standard care without the VR intervention. Anxiety levels will be measured using the State-Trait Anxiety Inventory (STAI) before the procedure (baseline) and after the procedure. |
| Intervention Group (Virtual Reality Intervention) | Experimental | Patients will experience the VR mindfulness intervention using the Tripp App or comparable applications.
Anxiety levels will be measured using the STAI before the VR experience, immediately after the VR experience, and after the procedure. Receives: Device: Intervention Group (Virtual Reality intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety level before and after the intervention
Measured using the State-Trait Anxiety Inventory (STAI), which provides a score from 20 to 80. Higher scores indicate more anxiety. Change from baseline to post-procedure will be compared between VR and control groups. Score on STAI (range 20-80)
Measured: 10 minutes before the procedure and 10 minutes after procedure (intervention group and control group)
Secondary outcomes (8)
Visual Facial Anxiety Scale Score
A 6-tier visual facial anxiety scale used to assess preoperative anxiety. Scores range from 1 (most anxious) to 6 (least anxious). Will be used as an alternative assessment alongside STAI. Visual scale score (1-6)
Measured: 10 minutes before the procedure and 10 minutes after procedure (intervention group and control group)
Pain Score
Pain levels will be assessed using a 10-point Numeric Rating Scale (NRS). Higher scores indicate greater pain. NRS score (0-10)
Measured: Immediately post-procedure
Amount of Pain Medication Used
Total amount of analgesics or anesthetics administered, based on patient record and clinical protocol (measured in mg)
Measured: During and immediately after procedure
Recovery Time
Measured in minutes to determine the duration of post-operative recovery.
Measured: 30 minutes after the end of procedure (before discharge).
Composite Patient Satisfaction Score
10-item emoji-based questionnaire scored from 1-5 or 1-3 per item, depending on the scale used. Total composite score ranges from 10-50 or 10-30. Higher scores indicate greater satisfaction. May be normalized to 0-100%. Unites of measure: Composite score (10-50) or percentage (0-100%)
Measured: 30 minutes after the end of procedure (before discharge).
Recovery Time
Duration of patient recovery (minutes)
Measured: 30 minutes after the end of procedure (before discharge).
Gender-specific Effectiveness
Subgroup analysis of anxiety reduction by gender (male vs. female). Measured using the State-Trait Anxiety Inventory (STAI), which provides a score from 20 to 80. Higher scores indicate more anxiety. Change from baseline to post-procedure will be compared between VR and control groups. Score on STAI (range 20-80)
Measured: Through study completion, an average of 1 year
Procedure-specific Effectiveness
Subgroup analysis of primary outcome by procedure type. Measured using the State-Trait Anxiety Inventory (STAI), which provides a score from 20 to 80. Higher scores indicate more anxiety. Change from baseline to post-procedure will be compared between VR and control groups. Score on STAI (range 20-80). Difference in mean STAI score change by procedure.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start10 Jul 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Melado, ART Fertility Clinics LLC
- Investigators
- Barbara Lawrenz, Research Director, Study director, ART Fertility Clinics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014267
- Sponsor's protocol ID
- 2503-ABU-007-LMV
- Status last verified
- May 2026
- First submitted
- 20 Mar 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: upon request
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Mindfulness and Anxiety Reduction in Fertility Procedures
- ClinicalTrials.gov ID
- NCT07014267
- Acronym / sponsor ID
- 2503-ABU-007-LMV
- Conditions
- Virtual Reality, Patient Experience
- Keywords
- anxiety, stress, pain perception, recovery duration, virtual reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jun 2025 (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.
This study aims to evaluate the effectiveness of a Virtual Reality (VR)-based mindfulness and meditation intervention in reducing anxiety among patients undergoing fertility-related surgical procedures. Anxiety is a common challenge in fertility treatments, often leading to emotional distress and increased pain perception. By incorporating a non-invasive VR intervention, the investigators seek to improve patient experience, minimize preoperative anxiety, and potentially reduce postoperative discomfort and recovery times. This randomized controlled trial (RCT) will compare standard care with a VR intervention in a clinical setting, measuring key outcomes such as anxiety levels, pain perception, recovery duration, and overall patient satisfaction. The findings may contribute to more patient centered fertility care, offering an innovative, scalable, and cost-effective approach to anxiety management in reproductive medicine.
Detailed description
This study examines the effectiveness of a Virtual Reality (VR) mindfulness intervention in reducing anxiety for patients undergoing fertility surgeries. The trial will compare VR with standard care, measuring outcomes like anxiety, pain, recovery time, and patient satisfaction. The results could provide a cost-effective, patient-centered approach to managing anxiety in fertility treatments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (No VR intervention) | No intervention | –Patients will receive standard care without the VR intervention. Anxiety levels will be measured using the State-Trait Anxiety Inventory (STAI) before the procedure (baseline) and after the procedure. |
| Intervention Group (Virtual Reality Intervention) | Experimental | Device: Intervention Group (Virtual Reality intervention)Patients will experience the VR mindfulness intervention using the Tripp App or comparable applications. Anxiety levels will be measured using the STAI before the VR experience, immediately after the VR experience, and after the procedure. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged 18-50.
- Scheduled for fertility-related surgical procedures.
- Able to provide informed consent.
Key exclusion criteria (3 listed)
- History of motion sickness or VR-related discomfort.
- Cognitive or psychological conditions affecting participation.
- Procedures requiring emergency intervention.
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 |
|---|---|---|
| Intervention Group (Virtual Reality intervention)Patients will experience the VR mindfulness intervention using the Tripp App or comparable applications. Anxiety levels will be measured using the STAI before the VR experience, immediately after the VR experience, and after the procedure. | Device | Intervention Group (Virtual Reality Intervention) |
Primary outcome
Change in anxiety level before and after the intervention
Time frame: 10 minutes before the procedure and 10 minutes after procedure (intervention group and control group)
Measured using the State-Trait Anxiety Inventory (STAI), which provides a score from 20 to 80. Higher scores indicate more anxiety. Change from baseline to post-procedure will be compared between VR and control groups. Score on STAI (range 20-80)
8 secondary outcomes
Visual Facial Anxiety Scale Score
Time frame: 10 minutes before the procedure and 10 minutes after procedure (intervention group and control group)
Pain Score
Time frame: Immediately post-procedure
Amount of Pain Medication Used
Time frame: During and immediately after procedure
Recovery Time
Time frame: 30 minutes after the end of procedure (before discharge).
Composite Patient Satisfaction Score
Time frame: 30 minutes after the end of procedure (before discharge).
Recovery Time
Time frame: 30 minutes after the end of procedure (before discharge).
Gender-specific Effectiveness
Time frame: Through study completion, an average of 1 year
Procedure-specific Effectiveness
Time frame: Through study completion, an average of 1 year
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 25 Jun 2026.
- Individual participant dataSharing planned: Undecided. upon request
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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.
Barbara Lawrenz, Research Director study director
ART Fertility Clinics LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group (Virtual Reality intervention) in people with Virtual Reality and Patient Experience, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. 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 United Arab Emirates. 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 Jonalyn Edades, Research Coordinator (+97126528000, jonalyn.edades@artfertilityclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety level before and after the intervention (time frame: 10 minutes before the procedure and 10 minutes after procedure (intervention group and control group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026.