NCT03437031

Brief Summary

The purpose of this study is to identify whether use of virtual reality devices can improve the pain management of women in labor and delivery. The investigators will perform a randomized controlled trial of patients in labor at Cedars-Sinai Medical Center.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2019

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

November 26, 2021

Completed
Last Updated

November 26, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

January 16, 2018

Results QC Date

June 4, 2021

Last Update Submit

October 29, 2021

Conditions

Labor PainVirtual RealityAlternative Medicine

Keywords

Labor PainVirtual RealityAlternative Medicine

Outcome Measures

Primary Outcomes (1)

  • Reduction in Pain

    Difference in pain scores pre-post intervention compared to control. The investigators will use the Visual Analog Scale (VAS) for Pain. The minimum pain is 1; the maximum is 10. Higher values represent more pain.

    4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention

Secondary Outcomes (4)

  • Number of Participants With a Need for Intravenous Pain Medication

    The total duration of the intervention (30 minutes)

  • Need for Epidural During the Intervention

    The total duration of the intervention (30 minutes)

  • Childbirth Self-Efficacy Inventory

    30 minutes

  • Number of Participants With a Need for Epidural During the Labor

    The total duration of the patient's labor (average 24 hours)

Study Arms (2)

Latent-Control

NO INTERVENTION

Patients in the latent phase of labor who will receive no intervention.

Latent-Virtual Reality (VR)

EXPERIMENTAL

Patients in the latent phase of labor who will receive the Virtual Reality (VR) intervention.

Device: Virtual Reality device

Interventions

Virtual Reality deviceDEVICE

For those patients randomized to VR, the study staff member will explain the use of the Samsung VR goggle set, and thereafter will allow the patient to use the device freely for up to 30 minutes. Intervals of 2-5 minutes is suggested for first-time use, and patients will be to allowed to discontinue it at any time as long as they are not experiencing any discomfort or side effects (dizziness, motion sickness, etc.). The study staff member will be present at all times, and will work with hospital staff as necessary to ensure the patient is receiving appropriate clinical care throughout the duration of the intervention.

Latent-Virtual Reality (VR)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • \>18 years old
  • Pregnant with term gestation
  • Nullipara
  • Pain due to contractions rated from 4-7
  • Contractions at least every 5 minutes x 30 minutes preceding
  • Pain scores obtained at least every 60 minutes

You may not qualify if:

  • Parous
  • Use of intravenous medications for pain relief prior to the intervention
  • Use of an epidural
  • Preterm gestation
  • Pain not due to contractions
  • Pain score of 3 or below or 8 or above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (2)

  • Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.

    PMID: 28356241BACKGROUND

  • 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.

    PMID: 27349654BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Melissa Wong, MD MHDS
Organization
Cedars Sinai
wongmsx@cshs.org
310-423-0895

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel randomized controlled trials
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 16, 2018

First Posted

February 19, 2018

Study Start

March 1, 2018

Primary Completion

February 19, 2019

Study Completion

February 19, 2019

Last Updated

November 26, 2021

Results First Posted

November 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)