Virtual Reality in Obstetric Patients
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|ClinicalTrials.gov Identifier: NCT03495531|
Recruitment Status : Active, not recruiting
First Posted : April 12, 2018
Last Update Posted : August 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Obstetric Pain Pain||Device: Virtual Reality||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Virtual Reality Obstetrics Phase 1 & Phase 2 Prospective Study|
|Actual Study Start Date :||July 3, 2018|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2022|
No Intervention: Standard of Care
Standard of Care
Experimental: VR Use
Obstetrics patients who use virtual reality
Device: Virtual Reality
Virtual Reality headset with calming scenery
- Virtual Reality vs Standard Of Care [ Time Frame: Throughout Study Completion, an average of 1-2 years. ]Investigators hope to determine if technology based distractions (VR headsets) are more effective than standard of care in obstetric patients for preventing high anxiety and pain during laboring procedures. This will be assessed using pre-/post- surveys.
- Parent/Patient Assessment of Virtual Reality Software [ Time Frame: Evaluated post procedure, between 5-60 minutes after such procedure. ]As a secondary aim of the study, the investigators seek to determine if the use of technology based distraction (i.e virtual reality) will result in higher patient satisfaction as well as evaluating which techniques or software scenery are the most effective for relaxation.
- Epidural/Combined Spinal-Epidural Dosing Requirements [ Time Frame: Duration of procedure, which is generally less than 2 hours ]Assessment of cumulative epidural dosing and the duration of epidural analgesia of participants through child-laboring procedures.
- Overall Change in Pain Scores Using Virtual Reality [ Time Frame: Duration of procedure, which is generally less than 2 hours ]Comparing whether passive or active interventions using VR are more effective in decreasing overall pain scores in participants by comparing pre-/post- procedure survey answers.
- Overall Change in Anxiety Scores Using Virtual Reality [ Time Frame: Duration of procedure, which is generally less than 2 hours ]Comparing whether passive or active interventions using VR are more effective in decreasing overall anxiety scores in participants by comparing pre-/post- procedure survey answers.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495531
|United States, California|
|Stanford, California, United States, 94305|