Clinical trial NCT03437031: Virtual Reality in Labor and Delivery for Reduction in Pain
Official title: Virtual Reality in Labor and Delivery for Reduction in Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Labor Pain
Virtual Reality
Alternative Medicine
Keywords: Labor Pain
Virtual Reality
Alternative Medicine
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized controlled trials
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Reduction in Pain
timeFrame: 4 hours prior to intervention, immediately pre-intervention, immediately post-intervention, 2, 4, 24 hours post-intervention
Secondary outcomes:
measure: Number of Participants With a Need for Intravenous Pain Medication
timeFrame: The total duration of the intervention (30 minutes)
measure: Need for Epidural During the Intervention
timeFrame: The total duration of the intervention (30 minutes)
measure: Childbirth Self-Efficacy Inventory
timeFrame: 30 minutes
measure: Number of Participants With a Need for Epidural During the Labor
timeFrame: The total duration of the patient's labor (average 24 hours)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
References:
citation: 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.
citation: 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.