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

Study Investigator

Status: Begins enrollment in 1 month

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

Treatments: Device: VR headset; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07288047

STUDY25090152

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

72 participants in 2 patient groups

Usual care only

Active Comparator group

Description:

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

Treatment:

Other: Usual Care

VR headset

Experimental group

Description:

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.

Treatment:

Other: Usual Care

Device: VR headset