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Trial record 3 of 61 for:    (complementary OR alternative) medicine AND (woman OR women OR female) | pain

Virtual Reality in Labor and Delivery for Reduction in Pain

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ClinicalTrials.gov Identifier: NCT03437031
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Kimberly Gregory, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment Phase
Labor Pain Virtual Reality Alternative Medicine Device: Virtual Reality device Not Applicable

Detailed Description:

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 hypothesize that use of virtual reality devices will result in a reduction in pain medication use, in epidural use, and prolong the duration of time prior to the patient receiving an epidural.

The study will be conducted as two parallel randomized controlled trials: one for latent labor patients and one for patients in active labor (defined by whether they are < 6 cm or > 6 cm). Within each phase of labor, there will be 20 in the Virtual Reality arm and 20 in the Control arm for a total of 80 patients.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel randomized controlled trials
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virtual Reality in Labor and Delivery for Reduction in Pain
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth

Arm Intervention/treatment
No Intervention: Latent-Control
Patients in the latent phase of labor who will receive no intervention.
Experimental: Latent-VR
Patients in the latent phase of labor who will receive the VR intervention.
Device: Virtual Reality device
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.

No Intervention: Active-Control
Patients in the active phase of labor who will receive no intervention.
Experimental: Active-VR
Patients in the active phase of labor who will receive the VR intervention.
Device: Virtual Reality device
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.




Primary Outcome Measures :
  1. Reduction in Pain [ Time Frame: 30 and 60 minutes ]
    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.


Secondary Outcome Measures :
  1. Need for intravenous pain medication [ Time Frame: The total duration of a patient's labor course until the baby is delivered ]
    IV pain medication during the intervention (yes/no), time to first dose of IV pain medication from the intervention (interval)

  2. Need for epidural [ Time Frame: The total duration of a patient's labor course until an epidural is received, an average of 24 hours ]
    Request for an epidural during the intervention (yes/no), time to request for an epidural from the end of the intervention (interval)

  3. Childbirth Self-Efficacy Inventory [ Time Frame: 30 minutes ]
    The Childbirth Self-Efficacy Inventory (CSEI) is a measure of how well a patient anticipates being able to perform certain tasks in labor such as relaxing their body, keeping calm, or not thinking about the pain. The investigators will ask to what extend they feel virtual reality would be able to influence their ability to do these things. https://www.ncbi.nlm.nih.gov/pubmed/8502766



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
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female
  2. >18 years old
  3. Pregnant with term gestation
  4. Nullipara
  5. Pain due to contractions rated from 4-7
  6. Contractions at least every 5 minutes x 30 minutes preceding
  7. Pain scores obtained at least every 60 minutes

Exclusion Criteria:

  1. Parous
  2. Use of intravenous medications for pain relief prior to the intervention
  3. Use of an epidural
  4. Preterm gestation
  5. Pain not due to contractions
  6. Pain score of 3 or below or 8 or above

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): NCT03437031


Contacts
Contact: Melissa S Wong, MD 310-423-0895 Melissa.Wong2@cshs.org
Contact: Kimberly D Gregory, MD MPH 310-423-0895 gregory@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Melissa S Wong, MD    310-423-0895    Melissa.Wong2@cshs.org   
Contact: Kimberly Gregory, MD MPH    3104230895    gregory@cshs.org   
Principal Investigator: Kimberly D Gregory, MD MPH         
Sponsors and Collaborators
Cedars-Sinai Medical Center

Publications:
Responsible Party: Kimberly Gregory, Professor, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03437031     History of Changes
Other Study ID Numbers: Pro00050082
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Kimberly Gregory, Cedars-Sinai Medical Center:
Labor Pain
Virtual Reality
Alternative Medicine

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms