Clinical trial NCT06029582: VR Headset for Pain During Pregnancy Termination
Official title: The Use of Virtual Reality Headset in Controlling Pain During Pregnancy Termination; a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Termination
Lead sponsor: St. Luke's Hospital, Pennsylvania
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain reduction
timeFrame: immediately after procedure (10 minutes)
Secondary outcomes:
measure: Anxiety reduction
timeFrame: pre and post procedure 1 hr before procedure and within 10 minutes after
Other outcomes:
measure: Heart rate variation
timeFrame: pre and post procedure, 10 minutes before and 10, 20 minutes after
measure: Blood pressure variation
timeFrame: pre and post procedure, 10 minutes before and 10, 20 minutes after
Locations:
city: Allentown
country: United States
facility: Allentown Women Center
state: Pennsylvania
Study officials:
affiliation: St Luke's University Hosptial
name: James N Anasti, MD
role: PRINCIPAL_INVESTIGATOR
References: