Virtual Reality for Mindfulness and Anxiety Reduction in Fertility Procedures

Not Applicable

Recruiting

• Conditions: Virtual Reality; Patient Experience

• Registration Number: NCT07014267
• Lead Sponsor: ART Fertility Clinics LLC

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.

Study Timeline

• Study First Submitted: 2025-03-20
• Status Verified: 2025-05
• Study First Submitted QC: 2025-06-09
• Study First Posted: 2025-06-10
• Study Start: 2025-07-10
• Last Update Submitted: 2025-07-24
• Last Update Posted: 2025-07-29
• Primary Completion: 2025-10-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in anxiety level before and after the intervention	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)

Secondary Outcome Measures

Name	Time	Method
Visual Facial Anxiety Scale Score	10 minutes before the procedure and 10 minutes after procedure (intervention group and control group)	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)
Amount of Pain Medication Used	During and immediately after procedure	Total amount of analgesics or anesthetics administered, based on patient record and clinical protocol (measured in mg)
Recovery Time	30 minutes after the end of procedure (before discharge).	Duration of patient recovery (minutes)
Composite Patient Satisfaction Score	30 minutes after the end of procedure (before discharge).	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%)
Gender-specific Effectiveness	Through study completion, an average of 1 year	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)
Procedure-specific Effectiveness	Through study completion, an average of 1 year	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.
Pain Score	Immediately post-procedure	Pain levels will be assessed using a 10-point Numeric Rating Scale (NRS). Higher scores indicate greater pain. NRS score (0-10)

Trial Locations

Locations (1)

ART Fertility Clinics LLC; 🇦🇪 Abu Dhabi, United Arab Emirates