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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
Must not have
Pregnancy patients requesting a termination under the age of 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre and post procedure 1 hr before procedure and within 10 minutes after
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 and seeking a termination of my pregnancy.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain reduction
Secondary study objectives
Anxiety reduction
Other study objectives
Blood pressure variation
Heart rate variation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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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
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