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Recruiting NCT07288047

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

No phase Interventional Abortion, First Trimester Pain Management Pain After Surgery Satisfaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VR headset, Usual Care.
Who it may be relevant to
Registry conditions: Abortion, First Trimester, Pain Management, Pain After Surgery, Satisfaction. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Virtual Reality as an Adjunctive Agent for the Management of Pain and Anxiety During First Trimester Procedural Abortion: a Randomized Controlled Trial

Overview

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

  • Device VR headset
    VR Headset: Meta Quest 3S Meditative nature videos provided via "Guided Meditation VR" app.
  • Other Usual Care
    Usual care for pain and anxiety management during a first trimester procedural abortion includes oral ibuprofen, intracervical block, and verbal analgesia.

Primary outcome measures

  • Pain scores during a first trimester procedural abortion [Time frame: Day of enrollment: immediately preprocedure and 15 minutes postprocedure.]
  • Anxiety scores during a first trimester procedural abortion [Time frame: Day of enrollment: immediately preprocedure and 15 minutes postprocedure.]
Secondary outcome measures (1)
  • Satisfaction with the first trimester procedural abortion [Time frame: Day of enrollment (immediately postprocedure) and one week after completion of the procedural abortion.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 2 centers
  • Center for Family Planning Research, Magee-Womens Hospital — Pittsburgh
  • Planned Parenthood of Western Pennsylvania — Pittsburgh

Identifiers

NCT: NCT07288047 · STUDY25090152

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗