Virtual Reality in Labor and Delivery for Reduction in Pain
- Conditions
- Labor PainVirtual RealityAlternative Medicine
- Interventions
- Device: Virtual Reality device
- Registration Number
- NCT03437031
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Latent-Virtual Reality (VR) Virtual Reality device Patients in the latent phase of labor who will receive the Virtual Reality (VR) intervention.
- Primary Outcome Measures
Name Time Method Reduction in Pain 4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention 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
Name Time Method Number of Participants With a Need for Epidural During the Labor The total duration of the patient's labor (average 24 hours) Epidural use during labor (yes/no)
Number of Participants With a Need for Intravenous Pain Medication The total duration of the intervention (30 minutes) IV pain medication during the intervention (yes/no)
Need for Epidural During the Intervention The total duration of the intervention (30 minutes) Number of participants with need for an epidural during the intervention
Childbirth Self-Efficacy Inventory 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. A fifteen-question scale reflecting degree of control where 1 is least control and 5 is most control per item. Minimum score 15 reflecting least total control; maximum score 75 reflecting maximal control.
Trial Locations
- Locations (1)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States