Virtual Reality for Mindfulness and Anxiety Reduction in Fertility Procedures

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorART Fertility Clinics LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients aged 18-50.

Scheduled for fertility-related surgical procedures.

Able to provide informed consent.

Disqualifiers

History of motion sickness or VR-related discomfort.

Cognitive or psychological conditions affecting participation.

Procedures requiring emergency intervention.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Control Group (No VR intervention)No intervention 0 interventions
Group B: Intervention Group (Virtual Reality Intervention)Experimental treatment 1 intervention

Trial outcomes

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)

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

Secondary outcomes

1

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)

Time frame
10 minutes before the procedure and 10 minutes after procedure (intervention group and control group)
2

Pain Score

Pain levels will be assessed using a 10-point Numeric Rating Scale (NRS). Higher scores indicate greater pain. NRS score (0-10)

Time frame
Immediately post-procedure
3

Amount of Pain Medication Used

Total amount of analgesics or anesthetics administered, based on patient record and clinical protocol (measured in mg)

Time frame
During and immediately after procedure
4

Recovery Time

Measured in minutes to determine the duration of post-operative recovery.

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

Other outcomes

Sponsors and contacts

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