VR Headset for Pain During Pregnancy Termination

NCT ID: NCT06029582

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2024-07-07

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.

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.

Conditions

Pregnancy Termination

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality headset

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

Group Type: EXPERIMENTAL

VR headset

Intervention Type: DEVICE

Virtual Reality Headset

controls

no headset

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

VR headset

Virtual Reality Headset

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St. Luke's Hospital, Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James N Anasti, MD

Role: PRINCIPAL_INVESTIGATOR

St Luke's University Hosptial

Locations

Allentown Women Center

Allentown, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

James N Anasti, MD

Role: CONTACT

anastij@slhn.org

484-526-8878

Facility Contacts

James N Anasti, MD

Role: primary

anastij@slhn.org

610-844-2106

Other Identifiers

SLIR-2023-55

Identifier Type: -

Identifier Source: org_study_id