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

NCT07288047 | Recruiting FDA Device

• 1 other identifier: STUDY25090152
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Abortion, First Trimester; Pain Management; Pain After Surgery; Satisfaction; Satisfaction With Care; Anxiety After Surgery

Keywords

satisfaction; virtual reality; procedural abortion; pain control; anxiety control

Outcome Measures

Primary Outcomes (2)

• 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.

  Day of enrollment: immediately preprocedure and 15 minutes postprocedure.

• 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.

  Day of enrollment: immediately preprocedure and 15 minutes postprocedure.

Secondary Outcomes (1)

• Satisfaction with the first trimester procedural abortion

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

Study Arms (2)

Usual care only

ACTIVE COMPARATOR

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

Other: Usual Care

VR headset

EXPERIMENTAL

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.

Device: VR headset; Other: Usual Care

Interventions

VR headset DEVICE

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

VR headset

Usual Care OTHER

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

Also known as: Routine care

Usual care only; VR headset

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at Planned Parenthood of Western Pennsylvania who have decided to undergo and are eligible for a procedural abortion.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Study Investigator: lead

Study Sites (2)

Center for Family Planning Research, Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Planned Parenthood of Western Pennsylvania

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Agnosia; Personal Satisfaction

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Study Coordinator

  Univeristy of Pittsburgh

  STUDY DIRECTOR

Central Study Contacts

Study Coordinator

CONTACT

412-641-5496; fpr@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 17, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)