Abortion, First Trimester, Pain Management, Pain After Surgery, Satisfaction, Satisfaction With Care, Anxiety After Surgery
Conditions
Keywords
satisfaction, virtual reality, procedural abortion, pain control, anxiety control
Brief summary
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.
Detailed description
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.
Interventions
DEVICEVR headset
VR Headset: Meta Quest 3S Meditative nature videos provided via "Guided Meditation VR" app.
OTHERUsual Care
Usual care for pain and anxiety management during a first trimester procedural abortion includes oral ibuprofen, intracervical block, and verbal analgesia.
Sponsors
Study Investigator
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at Planned Parenthood of Western Pennsylvania who have decided to undergo and are eligible for a procedural abortion. * 18 years old or older * \<14 weeks gestation on day of abortion * Able to comprehend written English * Willing to comply with the study protocol * Willing and able to provide informed consent
Exclusion criteria
* History of vertigo * History of epilepsy * Claustrophobia * Significant hearing or visual impairments (such as deafness or blindness) * Require hearing aids * Have an implanted medical device, such as cardiac pacemaker or defibrillator * Require misoprostol for cervical preparation * Prior unsuccessful attempt at abortion during this pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores during a first trimester procedural abortion | Day of enrollment: immediately preprocedure and 15 minutes postprocedure. | 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. |
| Anxiety scores during a first trimester procedural abortion | Day of enrollment: immediately preprocedure and 15 minutes postprocedure. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with the first trimester procedural abortion | Day of enrollment (immediately postprocedure) and one week after completion of the 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. |
Countries
United States
Contacts
CONTACTStudy Coordinator
STUDY_DIRECTORStudy Coordinator
Univeristy of Pittsburgh
Outcome results
None listed