Abortion, First TrimesterCALM-VRNCT07288047
Virtual Reality as a Method for Pain and Anxiety Control During First Trimester Procedural Abortion
A study testing VR headset in people with Abortion, First Trimester and Pain Management, run by Study Investigator at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion, First Trimester, Pain Management, Pain After Surgery
- What is being tested?
- VR headset
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Center for Family Planning Research, Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Study Coordinator, 412-641-5496, fpr@upmc.edu
- Recruiting
Planned Parenthood of Western Pennsylvania
Pittsburgh, Pennsylvania, 15213
Study Coordinator, 412-641-5496, fpr@upmc.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Abortion, First Trimester, Pain Management, Pain After Surgery, Satisfaction, Satisfaction With Care, Anxiety After Surgery
- Being tested
- VR headset, Usual Care
- Keywords
- satisfaction, virtual reality, procedural abortion, pain control, anxiety control
- Medical subject headings
- Agnosia, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR headsetDevice
VR Headset: Meta Quest 3S Meditative nature videos provided via "Guided Meditation VR" app.
Usual CareOther
Also called Routine care
Usual care for pain and anxiety management during a first trimester procedural abortion includes oral ibuprofen, intracervical block, and verbal analgesia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: VR headset; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day of enrollment: immediately preprocedure and 15 minutes postprocedure.
Secondary outcomes (1)
Satisfaction with the first trimester 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.
Measured: Day of enrollment (immediately postprocedure) and one week after completion of the procedural abortion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 May 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, First TrimesterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Study Investigator
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Study Investigator, University of Pittsburgh
- Investigators
- Study Coordinator, Study director, Univeristy of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288047
- Sponsor's protocol ID
- STUDY25090152
- Acronym
- CALM-VR
- Status last verified
- May 2026
- First submitted
- 11 Dec 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as an Adjunctive Agent for the Management of Pain and Anxiety During First Trimester Procedural Abortion: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07288047
- Acronym / sponsor ID
- CALM-VR / STUDY25090152
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Study InvestigatorUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care only | Active comparator | Other: Usual CareUsual care for pain and anxiety management during a first trimester procedural abortion includes oral ibuprofen, intracervical block, and verbal analgesia. |
| VR headset | Experimental | Device: VR headset, Other: Usual CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- History of vertigo
- History of epilepsy
- Claustrophobia
- Significant hearing or visual impairments (such as deafness or blindness)
- Require hearing aids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR headsetVR Headset: Meta Quest 3S Meditative nature videos provided via "Guided Meditation VR" app. | Device | VR headset |
| Usual CareAlso: Routine careUsual care for pain and anxiety management during a first trimester procedural abortion includes oral ibuprofen, intracervical block, and verbal analgesia. | Other | Usual care only, VR headset |
Primary outcome
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.
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.
1 secondary outcome
Satisfaction with the first trimester procedural abortion
Time frame: Day of enrollment (immediately postprocedure) and one week after completion of the procedural abortion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Coordinator study director
Univeristy of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR headset in people with Abortion, First Trimester and Pain Management, run by Study Investigator at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (412-641-5496, fpr@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores during a first trimester procedural abortion (time frame: Day of enrollment: immediately preprocedure and 15 minutes postprocedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.