Virtual Reality for Mindfulness and Anxiety Reduction in Fertility Procedures

NCT07014267 | Recruiting

• 1 other identifier: 2503-ABU-007-LMV
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality; Patient Experience

Keywords

anxiety; stress; pain perception; recovery duration; virtual reality

Outcome Measures

Primary Outcomes (1)

• 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)

  10 minutes before the procedure and 10 minutes after procedure (intervention group and control group)

Secondary Outcomes (8)

• Visual Facial Anxiety Scale Score

  10 minutes before the procedure and 10 minutes after procedure (intervention group and control group)

• Pain Score

  Immediately post-procedure

• Amount of Pain Medication Used

  During and immediately after procedure

• Recovery Time

  30 minutes after the end of procedure (before discharge).

• Composite Patient Satisfaction Score

  30 minutes after the end of procedure (before discharge).

Study Arms (2)

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.

Device: Intervention Group (Virtual Reality intervention)

Interventions

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.

Intervention Group (Virtual Reality Intervention)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

ART Fertility Clinics LLC

Abu Dhabi, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Barbara Lawrenz, Research Director

  ART Fertility Clinics LLC

  STUDY DIRECTOR

Central Study Contacts

Jonalyn Edades, Research Coordinator

CONTACT

+97126528000; jonalyn.edades@artfertilityclinics.com

Barbara Lawrenz, Research Director

CONTACT

+97126528000; barbara.lawrenz@artfertilityclinics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director - Abu Dhabi

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: June 10, 2025
• Study Start: July 10, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-05

Locations

AE (1)