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

NCT ID: NCT07288047

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

satisfaction virtual reality procedural abortion pain control anxiety control

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual care only

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

VR headset

Intervention Type DEVICE

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

Usual Care

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VR headset

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

Intervention Type DEVICE

Usual Care

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Routine care

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Study Investigator

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Study Investigator

Fellow

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Study Coordinator

Role: STUDY_DIRECTOR

Univeristy of Pittsburgh

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center for Family Planning Research, Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Planned Parenthood of Western Pennsylvania

Pittsburgh, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Study Coordinator

Role: CONTACT

Phone: 412-641-5496

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY25090152

Identifier Type: -

Identifier Source: org_study_id