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Behavioural Intervention

VR Headset for Pain Relief During Medical Abortion (VRPASAB Trial)

N/A

Recruiting

Led By James N Anasti, MD

Research Sponsored by St. Luke's Hospital, Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

VRPASAB Trial Summary

This trial tests if wearing a VRHS during a surgical pregnancy termination helps reduce pain. Participants will wear either a real or placebo headset and take a pain survey before and after the procedure.

Who is the study for?

This trial is for healthy adult women undergoing a first or second trimester pregnancy termination. It's not open to those under the age of 18.Check my eligibility

What is being tested?

The study is testing if using a VR headset during surgical pregnancy termination can reduce pain. Participants will be randomly given either the VR headset or a placebo headset and their pain levels will be surveyed before and after surgery.See study design

What are the potential side effects?

Since this trial involves a non-invasive intervention (VR headset), side effects are minimal but may include discomfort from wearing the device, dizziness, or motion sickness.

VRPASAB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre and post procedure 1 hr before procedure and within 10 minutes after

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre and post procedure 1 hr before procedure and within 10 minutes after

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre and post procedure 1 hr before procedure and within 10 minutes after for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain reduction

Secondary outcome measures

Anxiety reduction

Other outcome measures

Blood pressure variation

Heart rate variation

VRPASAB Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Reality headsetExperimental Treatment1 Intervention

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

Group II: controlsActive Control1 Intervention

no headset

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

St. Luke's Hospital, PennsylvaniaLead Sponsor

18 Previous Clinical Trials

3,126 Total Patients Enrolled

James N Anasti, MDPrincipal InvestigatorSt Luke's University Hosptial

1 Previous Clinical Trials

240 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still being admitted to this investigation?

"Yes, clinicaltrials.gov has information indicating that the trial is actively enrolling participants. It was first posted on June 20th of this year and updated most recently August 31st. This medical study requires 100 subjects from a single location to participate."

Answered by AI

How extensive is the recruitment process for this clinical investigation?

"Affirmative. The records found on clinicaltrials.gov affirm that this trial is actively seeking participants, which was first announced on June 20th of 2023 and updated most recently at the end August 31st. 100 patients will be accepted between 1 locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

VR Headset for Pain During Pregnancy Termination

2023. "VR Headset for Pain During Pregnancy Termination". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06029582.