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NCT Number: NCT07288047

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Family Planning Research, Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR headset

Device

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

Usual Care

Other

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

Other names: Routine care

Primary outcomes

  1. Pain scores during a first trimester procedural abortion

    Time frame: 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.

  2. Anxiety scores during a first trimester procedural abortion

    Time frame: 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 outcomes

  1. Satisfaction with the first trimester procedural abortion

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

412-641-5496

Sponsors and collaborators

Lead sponsor

Study Investigator

Other

Registry information

Official study title

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

Acronym: CALM-VR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
May 6, 2026

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.

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