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RecruitingNCT07014267Updated Jun 25, 2026

Virtual Reality for Mindfulness and Anxiety Reduction in Fertility Procedures

An interventional study of Intervention Group (Virtual Reality intervention) in Virtual Reality and Patient Experience, sponsored by ART Fertility Clinics LLC. Recruiting at 1 site in United Arab Emirates. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by ART Fertility Clinics LLC · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Virtual Reality
  • Patient Experience

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Keywords

  • anxiety
  • stress
  • pain perception
  • recovery duration
  • virtual reality
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • History of motion sickness or VR-related discomfort.
  • Cognitive or psychological conditions affecting participation.
  • Procedures requiring emergency intervention.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • No intervention
    Control Group (No VR 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.

  • Experimental
    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.

    Device: Intervention Group (Virtual Reality intervention)

Interventions

  • DeviceIntervention 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.

05

What researchers measure

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).

  5. Composite Patient Satisfaction Score

    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%)

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

  6. Recovery Time

    Duration of patient recovery (minutes)

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

  7. Gender-specific Effectiveness

    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)

    Time frame: Through study completion, an average of 1 year

  8. Procedure-specific Effectiveness

    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.

    Time frame: Through study completion, an average of 1 year

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided — upon request

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07014267
Lead sponsor
ART Fertility Clinics LLC
Responsible party
Laura Melado (Medical Director - Abu Dhabi, ART Fertility Clinics LLC) — Principal investigator
First posted
Jun 10, 2025
Start date
Jul 10, 2025
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 25, 2026

Study contacts

Jonalyn Edades, Research Coordinator
Contact
jonalyn.edades@artfertilityclinics.com
+97126528000
Barbara Lawrenz, Research Director
Contact
barbara.lawrenz@artfertilityclinics.com
+97126528000
Barbara Lawrenz, Research Director
study director · ART Fertility Clinics LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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