Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
Not provided
Not provided
Virtual reality (VR) has been used in health care settings to decrease anxiety and pain. This project is a feasibility study to evaluate whether virtual reality can be used in the setting of a first trimester pregnancy termination by D&C and whether the use of virtual reality (VR) headsets can help decrease anxiety for patients during this procedure.
The investigators will assess the practicality and qualitative experience of women using VR during first trimester surgical abortion under local anesthesia. Semi-structured interviews will be conducted to understand the patient's experience of using VR. Surveys evaluating anxiety will be administered to women before and after surgical abortion. Investigators plan to enroll 30 patients in order to obtain an effect size for future studies. A group of control patients will be enrolled; these patients will receive standard care and will be compared to the anxiety scores of the group receiving VR. The mean and standard deviation of anxiety scores for each group will be used to calculate power for future studies.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Intervention | Experimental | VR headsets consist of a Samsung phone dedicated to playing programs designed by the AppliedVR company. The phone is inserted in the front of the headset and can play videos that can be then viewed by the participant while wearing the headset. Participants in the experimental arm will be fitted with VR headsets prior to first trimester abortion and will wear the headset during the procedure. Participants will be able to choose a program of their preference (ex. guided meditation, beautiful scenery). The patient may remove the VR device at any time during the procedure. After the procedure, investigators will carry out a qualitative interview with the participant and ask about the experience of using the VR headset during first trimester abortion. Patients will also complete surveys evaluating procedure-related anxiety. These will be administered before and after the procedure. |
|
| Control arm | No Intervention | In the control group, participants will not use virtual reality during the procedure. Patients in the control arm will complete surveys evaluating procedure-related anxiety. These will be administered before and after the procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| applied VR headset | Device | Virtual reality (VR) is a three-dimensional experience created by a headset fitted with a video display. The device, designed to be worn on the face, immerses the viewer in a virtual world and can create a visual distraction from the patient's present situation. We will use a commercially available VR device, comprised of a phone and headset. The phone is inserted into the headset to act as the visual display that can create three dimensional environments. The patient will then choose the virtual reality experience she prefers from the two relaxation programs available. The VR device will be introduced to the participant and fitted to her head prior to the procedure. The device is intended to be worn during the full length of the procedure until the conclusion of the D&C, however the participant may decide to stop wearing the device and choose to end the VR experience at any time. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion. | Number of participants able to use VR device throughout the entire duration of first trimester surgical abortion. | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Procedure Related Anxiety as Assessed by the Visual Analog Scale (VAS). | Mean change in procedure related anxiety score as assessed by the Visual Analog Scale (VAS). The Visual Analog Scale is a 11 point scale ranging from 0 to 10. 0 indicates the least amount of discomfort or anxiety whereas 10 represents the most amount of discomfort or anxiety. Participants were surveyed on their level of discomfort prior to and after the procedure. The difference of these scores was taken and the average of each group is presented in as a result. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients must be biologically female, willing to have a first trimester abortion
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles Obstetrics and Gynecology Clinic | Los Angeles | California | 90024 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27349654 | Background | Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801. | |
| 27906757 | Background | Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients were assigned to either experimental or control group via convenient sampling.
15 participants recruited to each group (experimental vs control)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality Intervention | Participants in the experimental arm were fitted with VR headsets prior to first trimester abortion and could choose to wear the headset during the procedure. Participants chose a program of their preference (ex. guided meditation, beautiful scenery). The patient was able to remove the VR device at any time during the procedure. |
| FG001 | Control Arm | In the control group, participants did not use virtual reality during the procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Reality Intervention | Participants in the experimental arm were fitted with VR headsets prior to first trimester abortion and could choose to wear the headset during the procedure. Participants chose a program of their preference (ex. guided meditation, beautiful scenery). The patient was able to remove the VR device at any time during the procedure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion. | Number of participants able to use VR device throughout the entire duration of first trimester surgical abortion. | Posted | Number | participants | 15 minutes |
|
|
During period of participant enrollment and data collection (45 minutes)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality Intervention | Participants in the experimental arm were fitted with VR headsets prior to first trimester abortion and could choose to wear the headset during the procedure. Participants chose a program of their preference (ex. guided meditation, beautiful scenery). The patient was able to remove the VR device at any time during the procedure. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aparna Sridhar, Associate Clinical Professor | UCLA | 3107947274 | asridhar@mednet.ucla.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2017 | May 4, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
Time series study with 15 controls and 15 experimental group. Investigators plan to enroll 30 patients in order to obtain an effect size for future studies. The mean and standard deviation of anxiety scores for each group will be used to calculate power for future studies.
Not provided
Not provided
Not provided
Not provided
|
| 30 min |
| 27904638 | Background | Shourab NJ, Zagami SE, Golmakhani N, Mazlom SR, Nahvi A, Pabarja F, Talebi M, Rizi SM. Virtual reality and anxiety in primiparous women during episiotomy repair. Iran J Nurs Midwifery Res. 2016 Sep-Oct;21(5):521-526. doi: 10.4103/1735-9066.193417. |
| BG001 |
| Control Arm |
In the control group, participants did not use virtual reality during the procedure. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Change in Procedure Related Anxiety as Assessed by the Visual Analog Scale (VAS). | Mean change in procedure related anxiety score as assessed by the Visual Analog Scale (VAS). The Visual Analog Scale is a 11 point scale ranging from 0 to 10. 0 indicates the least amount of discomfort or anxiety whereas 10 represents the most amount of discomfort or anxiety. Participants were surveyed on their level of discomfort prior to and after the procedure. The difference of these scores was taken and the average of each group is presented in as a result. | Posted | Mean | Standard Deviation | units on a scale | 30 min |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Control Arm | In the control group, participants did not use virtual reality during the procedure. | 0 | 15 | 0 | 15 | 0 | 15 |
Not provided
Not provided