Virtual Reality as a Method for Pain and Anxiety Control During First Trimester Procedural Abortion (CALM-VR)

May 1, 2026 updated by: Study Investigator

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Study Coordinator
  • Phone Number: 412-641-5496
  • Email: fpr@upmc.edu

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Center for Family Planning Research, Magee-Womens Hospital
        • Contact:
          • Study Coordinator
          • Phone Number: 412-641-5496
          • Email: fpr@upmc.edu
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Planned Parenthood of Western Pennsylvania
        • Contact:
          • Study Coordinator
          • Phone Number: 412-641-5496
          • Email: fpr@upmc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care only
Usual care for pain and anxiety management during a first trimester procedural abortion includes oral ibuprofen, intracervical block, and verbal analgesia.
Other: Usual Care
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
Experimental: VR headset
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.
Other: Usual Care
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
Device: VR headset
VR Headset: Meta Quest 3S Meditative nature videos provided via "Guided Meditation VR" app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day of enrollment (immediately postprocedure) and one week after completion of the procedural abortion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study Investigator

Investigators

  • Study Director: Study Coordinator, Univeristy of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY25090152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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