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RecruitingNCT06029582VRPASABUpdated Sep 8, 2023

VR Headset for Pain During Pregnancy Termination

An interventional study of VR headset in Pregnancy Termination, sponsored by St. Luke's Hospital, Pennsylvania. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by St. Luke's Hospital, Pennsylvania · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

The goal of this randomized control study is to see if virtual reality headsets (VRHS) are useful in women undergoing surgical pregnancy termination. The main questions it aims to answer are:

Do VRHS decrease the pain associated with surgical pregnancy termination Participants will wear the VRHS during the surgery and take a pain survey before and after the procedure. The pain assessment will be compared to placebo headset which will be randomly assigned.

Read the detailed description

Use of virtual reality headsets have been employed in cancer and behavioral medicine fields with moderate success in controlling anxiety stress and pain. The decision to terminate a pregnancy can create significant stress and anxiety. In the US, there are over 900,000 pregnancy terminations each year with many patients undergoing dilation and evacuation with minimal anesthesia. We plan to assess virtual reality headset's ability to decrease pain associated with surgical termination of pregnancy.

Patient's will be recruited from a single outpatient family-planning center. Inclusion criteria include all patients over the age of 18 that are undergoing a surgical termination of pregnancy in the first and second trimester under local and/or conscious sedation anesthesia. Patients under the age of 18 with significant medical comorbidities will be excluded. Patient demographics including age, BMI, obstetric/ gynecology history, and prior terminations will be collected. Patients will be given pre- procedure survey to assess anxiety and stress. The survey will be self-administered with assistance from study personnel. Patients will then be randomized to either the virtual reality headset or no headset. The procedure will be then performed with the headsets on the patients. Amount and type of local anesthesia employed will be recorded. After the procedure (within 1 hour), the individuals will be resurveyed for both stress and anxiety, with the addition of a visual analog scale to assessing pain associated with the procedure. Pre and post vital signs will also be extracted from the chart. The patient as well as the clinician performing the procedure will be masked as to the intervention. We will require 50 patients per arm assuming a 30% reduction in the pain scale (power 80%, 95% CI, with SD of 0.70). Logistic regression will be performed for those comorbidities that may be influence our outcome, such as age, BMI, prior terminations.

02

Conditions studied

  • Pregnancy Termination
03

In context

Lead sponsor

St. Luke's Hospital, Pennsylvania is the lead sponsor of 17 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • all healthy patients undergoing a first or second trimester pregnancy termination

Exclusion criteria

Exclusion Criteria:

  • pregnancy patients requesting a termination under the age of 18
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Virtual Reality headset

    Individuals will wear the Virtual Reality Headset that produce a calming scenario

    Device: VR headset

  • No intervention
    controls

    no headset

Interventions

  • DeviceVR headset

    Virtual Reality Headset

06

What researchers measure

Primary outcomes

  1. Pain reduction

    A pain scale (visual analog scale) will be used to assess reduction of pain (scale 1-10) one being no pain, 10 highest level of pain

    Time frame: immediately after procedure (10 minutes)

Secondary outcomes

  1. Anxiety reduction

    A scale will be used to assess anxiety (Visual analog scale: scale 1-10) 1 being no stress, 10 being highest level of stress

    Time frame: pre and post procedure 1 hr before procedure and within 10 minutes after

Other outcomes

  1. Heart rate variation

    Changes in heart rate in beats per minute

    Time frame: pre and post procedure, 10 minutes before and 10, 20 minutes after

  2. Blood pressure variation

    Changes in blood Pressure (mm/Hg)

    Time frame: pre and post procedure, 10 minutes before and 10, 20 minutes after

07

Study locations

1 of 1 sites recruiting
  • Allentown Women Center
    Allentown, Pennsylvania 18015, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06029582
Lead sponsor
St. Luke's Hospital, Pennsylvania
Responsible party
Sponsor
First posted
Sep 8, 2023
Start date
Jun 20, 2023
Primary completion
Jun 8, 2024 (estimated)
Completion
Jul 7, 2024 (estimated)
Last update
Sep 8, 2023

Study contacts

James N Anasti, MD
Contact
anastij@slhn.org
484-526-8878
James N Anasti, MD
principal investigator · St Luke's University Hosptial

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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