Virtual Reality in Labor and Delivery for Reduction in Pain

Labor Pain Clinical Trial

Official title:

Virtual Reality in Labor and Delivery for Reduction in Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03437031
• Other study ID #: Pro00050082
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: February 19, 2019

Study information

• Verified date: October 2021
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: February 19, 2019
• Est. primary completion date: February 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alternative Medicine
• Labor Pain
• Virtual Reality

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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With a Need for Intravenous Pain Medication	IV pain medication during the intervention (yes/no)	The total duration of the intervention (30 minutes)
Secondary	Need for Epidural During the Intervention	Number of participants with need for an epidural during the intervention	The total duration of the intervention (30 minutes)
Secondary	Childbirth Self-Efficacy Inventory	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.	30 minutes
Secondary	Number of Participants With a Need for Epidural During the Labor	Epidural use during labor (yes/no)	The total duration of the patient's labor (average 24 hours)