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Recruiting NCT07014267

Virtual Reality for Mindfulness and Anxiety Reduction in Fertility Procedures

No phase Interventional Virtual Reality Patient Experience

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention Group (Virtual Reality intervention).
Who it may be relevant to
Registry conditions: Virtual Reality, Patient Experience. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Arab Emirates
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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)]
Secondary outcome measures (8)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United Arab Emirates · 1 center
  • ART Fertility Clinics LLC — Abu Dhabi

Identifiers

NCT: NCT07014267 · 2503-ABU-007-LMV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗