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The goal of this clinical trial is to learn whether use of a virtual reality (VR) headset showing a meditative nature video will help reduce pain and anxiety during a first trimester procedural abortion. Investigators will enroll 72 patients undergoing a first trimester procedural abortion with usual care to manage pain and anxiety compared to use of a VR headset in addition to usual care to see if use of the VR headset will decrease pain and anxiety and increase satisfaction with the procedure.
While procedural abortions are common outpatient procedures, providing optimal pain and anxiety relief during these procedures is challenging. With rapidly developing technological advances, virtual reality (VR) has emerged as a promising modality to help manage pain and anxiety control in the medical field, including obstetrics and gynecology. However, there are no studies evaluating the effect of VR on pain during a procedural abortion.
The goal of this randomized controlled trial is to primarily evaluate whether using a VR headset to display a meditative nature video as a noninvasive, low risk technology may reduce pain and anxiety for patients undergoing a first trimester procedural abortion in an outpatient setting. Investigators will also evaluate factors influencing satisfaction with the procedure. Investigators will compare use of the VR headset with usual care, to usual care only; for a first trimester procedural abortion, usual care includes oral pain medications, local anesthetic medication in the cervix, and verbal reassurance. Participants will be asked to complete a survey before, after, and one week following the procedure to assess pain, anxiety, and overall satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care only | Active Comparator | Usual care for pain and anxiety management during a first trimester procedural abortion includes oral ibuprofen, intracervical block, and verbal analgesia. |
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| VR headset | Experimental | Participants will wear the VR headset during the first trimester procedural abortion, in addition to usual care for pain and anxiety management. The headset will display a meditative nature video throughout the procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR headset | Device | VR Headset: Meta Quest 3S Meditative nature videos provided via "Guided Meditation VR" app. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain scores during a first trimester procedural abortion | Pain will be measured on a visual analogue scale during and after the procedural abortion via a REDCap survey. The scale is from 0-100, with 0 being "No pain" and 100 being the "Worst pain of my life". The difference in this score (post-procedure minus pre-procedure) is what will be compared between study arms. | Day of enrollment: immediately preprocedure and 15 minutes postprocedure. |
| Anxiety scores during a first trimester procedural abortion | Anxiety will be measured on a visual analogue scale during and after the procedural abortion via a REDCap survey. The scale is from 0-100, with 0 being "No anxiety or fear" and 100 being the "Worst anxiety or fear of my life". The difference in this score (post-procedure minus pre-procedure) is what will be compared between study arms. | Day of enrollment: immediately preprocedure and 15 minutes postprocedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with the first trimester procedural abortion | Satisfaction will be assessed on a Likert scale using surveys administered on the day of the procedure and one week after the procedure. A score of 1 = very dissatisfied, and a score of 5 = very satisfied. | Day of enrollment (immediately postprocedure) and one week after completion of the procedural abortion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 412-641-5496 | fpr@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Study Coordinator | Univeristy of Pittsburgh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Family Planning Research, Magee-Womens Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
There are currently no plans to share the data, however it is possible we may choose to share the data with other groups or individuals interested in this topic. Should we choose to share, the data will be de-identified and a data use agreement will be executed as needed.
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| Usual Care | Other | Usual care for pain and anxiety management during a first trimester procedural abortion includes oral ibuprofen, intracervical block, and verbal analgesia. |
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| Planned Parenthood of Western Pennsylvania | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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