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NCT Number: NCT07014267

Virtual Reality for Mindfulness and Anxiety Reduction in Fertility Procedures

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ART Fertility Clinics LLC

Abu Dhabi, United Arab Emirates

Location status: Recruiting

Location contact

Barbara Lawrenz, Research Director

CONTACT

[email protected]

+97126528000

Jonalyn, Research Coordinator

CONTACT

[email protected]

+97126528000

Laura Melado, Medical Director

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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)

    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 outcomes

  1. Visual Facial Anxiety Scale Score

    Time frame: 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)

  2. Pain Score

    Time frame: 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)

  3. Amount of Pain Medication Used

    Time frame: During and immediately after procedure

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

  4. Recovery Time

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

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

  5. Composite Patient Satisfaction Score

    Time frame: 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%)

  6. Recovery Time

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

    Duration of patient recovery (minutes)

  7. Gender-specific Effectiveness

    Time frame: 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)

  8. Procedure-specific Effectiveness

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Lawrenz, Research Director

CONTACT

[email protected]

+97126528000

Jonalyn Edades, Research Coordinator

CONTACT

[email protected]

+97126528000

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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