ART Fertility Clinics LLC
Abu Dhabi, United Arab Emirates
Location status: Recruiting
Location contact
Barbara Lawrenz, Research Director
CONTACT
Jonalyn, Research Coordinator
CONTACT
Laura Melado, Medical Director
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07014267
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.
Interested in participating?
Request Info18 year–50 year
All sexes
Interventional
Not applicable
Abu Dhabi, United Arab Emirates
Location status: Recruiting
Barbara Lawrenz, Research Director
CONTACT
Jonalyn, Research Coordinator
CONTACT
Laura Melado, Medical Director
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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)
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)
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)
Time frame: During and immediately after procedure
Total amount of analgesics or anesthetics administered, based on patient record and clinical protocol (measured in mg)
Time frame: 30 minutes after the end of procedure (before discharge).
Measured in minutes to determine the duration of post-operative recovery.
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%)
Time frame: 30 minutes after the end of procedure (before discharge).
Duration of patient recovery (minutes)
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)
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.
Contact information is provided by the study sponsor or research team.
Barbara Lawrenz, Research Director
CONTACT
Jonalyn Edades, Research Coordinator
CONTACT
ART Fertility Clinics LLC
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT07689461
Anxiety, Anxiety Disorders
Malatya, Turkey (Türkiye)
View Trial DetailsNCT07055178
Anxiety, Anxiety Disorders
Winnipeg, Manitoba, Canada
View Trial DetailsNCT07317271
Anxiety, Anxiety Disorders
Baltimore, Maryland, United States
View Trial DetailsNCT07450456
Anxiety, Anxiety Disorders
Lugano, Canton Ticino, Switzerland
View Trial Details