Virtual Reality in Obstetric Patients

NCT03495531 | Completed

• 1 other identifier: 45042
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Pain; Pain

Keywords

virtual reality; obstetrics; labor procedures; regional anesthesia

Outcome Measures

Primary Outcomes (1)

• Virtual Reality vs Standard Of Care

  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.

  Throughout Study Completion, an average of 1-2 years.

Secondary Outcomes (4)

• Parent/Patient Assessment of Virtual Reality Software

  Evaluated post procedure, between 5-60 minutes after such procedure.

• Epidural/Combined Spinal-Epidural Dosing Requirements

  Duration of procedure, which is generally less than 2 hours

• Overall Change in Pain Scores Using Virtual Reality

  Duration of procedure, which is generally less than 2 hours

• Overall Change in Anxiety Scores Using Virtual Reality

  Duration of procedure, which is generally less than 2 hours

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard of Care

VR Use

EXPERIMENTAL

Obstetrics patients who use virtual reality

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

Virtual Reality headset with calming scenery

VR Use

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Obstetrics patients undergoing various child-laboring procedures
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

LPCH/SHC

Stanford, California, 94305, United States

Location

Related Publications (7)

• Poggi L, Goutaudier N, Sejourne N, Chabrol H. When Fear of Childbirth is Pathological: The Fear Continuum. Matern Child Health J. 2018 May;22(5):772-778. doi: 10.1007/s10995-018-2447-8.

  PMID: 29484511 RESULT

• Demsar K, Svetina M, Verdenik I, Tul N, Blickstein I, Globevnik Velikonja V. Tokophobia (fear of childbirth): prevalence and risk factors. J Perinat Med. 2018 Feb 23;46(2):151-154. doi: 10.1515/jpm-2016-0282.

  PMID: 28379837 RESULT

• Wulff V, Hepp P, Fehm T, Schaal NK. Music in Obstetrics: An Intervention Option to Reduce Tension, Pain and Stress. Geburtshilfe Frauenheilkd. 2017 Sep;77(9):967-975. doi: 10.1055/s-0043-118414. Epub 2017 Sep 25.

  PMID: 28959060 RESULT

• Gokyildiz Surucu S, Ozturk M, Avcibay Vurgec B, Alan S, Akbas M. The effect of music on pain and anxiety of women during labour on first time pregnancy: A study from Turkey. Complement Ther Clin Pract. 2018 Feb;30:96-102. doi: 10.1016/j.ctcp.2017.12.015. Epub 2017 Dec 19.

  PMID: 29389487 RESULT

• Anderson AP, Mayer MD, Fellows AM, Cowan DR, Hegel MT, Buckey JC. Relaxation with Immersive Natural Scenes Presented Using Virtual Reality. Aerosp Med Hum Perform. 2017 Jun 1;88(6):520-526. doi: 10.3357/AMHP.4747.2017.

  PMID: 28539139 RESULT

• Hoffman HG, Seibel EJ, Richards TL, Furness TA, Patterson DR, Sharar SR. Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. J Pain. 2006 Nov;7(11):843-50. doi: 10.1016/j.jpain.2006.04.006.

  PMID: 17074626 RESULT

• Dahlquist LM, Weiss KE, Law EF, Sil S, Herbert LJ, Horn SB, Wohlheiter K, Ackerman CS. Effects of videogame distraction and a virtual reality type head-mounted display helmet on cold pressor pain in young elementary school-aged children. J Pediatr Psychol. 2010 Jul;35(6):617-25. doi: 10.1093/jpepsy/jsp082. Epub 2009 Sep 28.

  PMID: 19786489 RESULT

MeSH Terms

Conditions

Labor Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 12, 2018
• Study Start: July 3, 2018
• Primary Completion: March 11, 2021
• Study Completion: March 11, 2021
• Last Updated: September 27, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)