Health TrialsbyHealthPanel

Virtual Reality as a Method for Pain and Anxiety Control During First Trimester Procedural Abortion

ConditionsAbortion, First TrimesterPain ManagementPain After SurgerySatisfactionSatisfaction With CareAnxiety After Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStudy Investigator

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of vertigo

History of epilepsy

Claustrophobia

Significant hearing or visual impairments (such as deafness or blindness)

Trial design

Design model

Parallel

Treatments tested in this trial

  • VR headset

    Device

    VR Headset: Meta Quest 3S Meditative nature videos provided via "Guided Meditation VR" app.

  • Usual Care

    Other intervention

    Usual care for pain and anxiety management during a first trimester procedural abortion includes oral ibuprofen, intracervical block, and verbal analgesia.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Usual care onlyActive comparator 1 intervention
Group B: VR headsetExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Day of enrollment: immediately preprocedure and 15 minutes postprocedure.
2

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.

Time frame
Day of enrollment: immediately preprocedure and 15 minutes postprocedure.

Secondary outcomes

1

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.

Time frame
Day of enrollment (immediately postprocedure) and one week after completion of the procedural abortion.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Study Investigator

Lead sponsor

University of Pittsburgh

Sponsor institution

Source ClinicalTrials.gov
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