NCT06029582

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2024

Completed
Last Updated

September 8, 2023

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

June 20, 2023

Last Update Submit

August 31, 2023

Conditions

Pregnancy Termination

Outcome Measures

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

    immediately after procedure (10 minutes)

Secondary Outcomes (1)

  • Anxiety reduction

    pre and post procedure 1 hr before procedure and within 10 minutes after

Other Outcomes (2)

  • Heart rate variation

    pre and post procedure, 10 minutes before and 10, 20 minutes after

  • Blood pressure variation

    pre and post procedure, 10 minutes before and 10, 20 minutes after

Study Arms (2)

Virtual Reality headset

EXPERIMENTAL

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

Device: VR headset

controls

NO INTERVENTION

no headset

Interventions

VR headsetDEVICE

Virtual Reality Headset

Virtual Reality headset

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnancy patients requesting a termination under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allentown Women Center

Allentown, Pennsylvania, 18015, United States

RECRUITING

Study Officials

  • James N Anasti, MD

    St Luke's University Hosptial

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James N Anasti, MD

CONTACT

484-526-8878anastij@slhn.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2023

First Posted

September 8, 2023

Study Start

June 20, 2023

Primary Completion

June 8, 2024

Study Completion

July 7, 2024

Last Updated

September 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)