VR Headset for Pain During Pregnancy Termination (VRPASAB)

The Use of Virtual Reality Headset in Controlling Pain During Pregnancy Termination; a Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Termination
• Intervention / Treatment: Device: VR headset

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James N Anasti, MD; Phone Number: 484-526-8878; Email: anastij@slhn.org

Study Locations

• United States
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18015
      • Recruiting
      • Allentown Women Center
      • Contact: James N Anasti, MD; Phone Number: 610-844-2106; Email: anastij@slhn.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality headset; Individuals will wear the Virtual Reality Headset that produce a calming scenario	Device: VR headset; Virtual Reality Headset
No Intervention: controls; no headset

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	pre and post procedure 1 hr before procedure and within 10 minutes after

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variation	Changes in heart rate in beats per minute	pre and post procedure, 10 minutes before and 10, 20 minutes after
Blood pressure variation	Changes in blood Pressure (mm/Hg)	pre and post procedure, 10 minutes before and 10, 20 minutes after

Collaborators and Investigators

• Sponsor: St. Luke's Hospital, Pennsylvania
• Investigators: Principal Investigator: James N Anasti, MD, St Luke's University Hosptial

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): June 8, 2024
• Study Completion (Estimated): July 7, 2024

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SLIR-2023-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No