Patient Experience, Virtual Reality
Conditions
Keywords
anxiety, stress, pain perception, recovery duration, virtual reality
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.
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
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.
Sponsors
ART Fertility Clinics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety level before and after the intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Facial Anxiety Scale Score | 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) |
| Pain Score | 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) |
| Amount of Pain Medication Used | During and immediately after procedure | Total amount of analgesics or anesthetics administered, based on patient record and clinical protocol (measured in mg) |
| Recovery Time | 30 minutes after the end of procedure (before discharge). | Measured in minutes to determine the duration of post-operative recovery. |
| Composite Patient Satisfaction Score | 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%) |
| Gender-specific Effectiveness | 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) |
| Procedure-specific Effectiveness | 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. |
Countries
United Arab Emirates
Contacts
CONTACTJonalyn Edades, Research Coordinator
CONTACTBarbara Lawrenz, Research Director
STUDY_DIRECTORBarbara Lawrenz, Research Director
ART Fertility Clinics LLC
Outcome results
None listed