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Virtual Reality in Obstetric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495531
Recruitment Status : Active, not recruiting
First Posted : April 12, 2018
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Samuel Rodriguez, Stanford University

Brief Summary:
The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety and pain scores in women who are undergoing child laboring procedures. The anticipated primary outcome will be a reduction of pregnant females overall anxiety and pain scores before and after such procedure(s), including but not limited to epidural/combined spinal epidural (CSE), IV placement and/or labor.

Condition or disease Intervention/treatment Phase
Obstetric Pain Pain Device: Virtual Reality Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Obstetrics patients undergoing various child-laboring procedures
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 and over
  • Able to consent
  • Obstetric patients who had either have a history of, planning to have, or currently having an child laboring related procedures such as IV placement, epidural/CSE placement and/or labor.

Exclusion Criteria:

  • Inclusion Criteria:
  • Age 18 and over
  • Able to consent
  • Obstetric patients who had either have a history of, planning to have, or currently having an child laboring related procedures such as IV placement, epidural/CSE placement and/or labor.

Information from the National Library of Medicine

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


Locations
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United States, California
LPCH/SHC
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Publications of Results:

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Responsible Party: Samuel Rodriguez, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03495531    
Other Study ID Numbers: 45042
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be de-identified and used collectively for research analysis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samuel Rodriguez, Stanford University:
virtual reality
obstetrics
labor procedures
regional anesthesia
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations