Recruiting

VR Headset

Sponsor:

St. Luke's Hospital, Pennsylvania

Code:

NCT06029582

Conditions

Pregnancy Termination

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VR headset

Study Details

Brief 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.

Conditions

Pregnancy Termination

Study ID

NCT06029582

Start date

Jun 20, 2023

Status verified date

Aug, 2023

Completion date

Jul 7, 2024

Anticipated

Primary completion date

Jun 8, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy patients requesting a termination under the age of 18

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual Reality headset

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

no intervention: controls

no headset

Interventions

VR headset

Virtual Reality Headset

Primary outcome measure

  • Pain reduction [ Time Frame: immediately after procedure (10 minutes) ]

Central Contacts and Locations

Central contacts

James N Anasti, MD

484-526-8878anastij@slhn.org

Locations

Allentown Women Center

Recruiting

Allentown, Pennsylvania, United States, 18015

Contacts

James N Anasti, MD

610-844-2106anastij@slhn.org

More Information

Sponsor

St. Luke's Hospital, Pennsylvania

Last update posted

Sep 8, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Luke's Hospital, Pennsylvania on 2023-09-08.