Clinical trial NCT07014267: Virtual Reality for Mindfulness and Anxiety Reduction in Fertility Procedures
Official title: Virtual Reality for Mindfulness and Anxiety Reduction in Fertility Procedures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Virtual Reality
Patient Experience
Keywords: anxiety
stress
pain perception
recovery duration
virtual reality
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-50.
* Scheduled for fertility-related surgical procedures.
* Able to provide informed consent.

Exclusion Criteria:

* History of motion sickness or VR-related discomfort.
* Cognitive or psychological conditions affecting participation.
* Procedures requiring emergency intervention.

Primary outcomes:
measure: Change in anxiety level before and after the intervention
timeFrame: 10 minutes before the procedure and 10 minutes after procedure (intervention group and control group)
Secondary outcomes:
measure: Visual Facial Anxiety Scale Score
timeFrame: 10 minutes before the procedure and 10 minutes after procedure (intervention group and control group)
measure: Pain Score
timeFrame: Immediately post-procedure
measure: Amount of Pain Medication Used
timeFrame: During and immediately after procedure
measure: Recovery Time
timeFrame: 30 minutes after the end of procedure (before discharge).
measure: Composite Patient Satisfaction Score
timeFrame: 30 minutes after the end of procedure (before discharge).
measure: Recovery Time
timeFrame: 30 minutes after the end of procedure (before discharge).
measure: Gender-specific Effectiveness
timeFrame: Through study completion, an average of 1 year
measure: Procedure-specific Effectiveness
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: ART Fertility Clinics LLC
Study officials:
affiliation: ART Fertility Clinics LLC
name: Barbara Lawrenz, Research Director
role: STUDY_DIRECTOR
References: