NCT03437031

Virtual Reality in Labor and Delivery for Reduction in Pain

Terminated NA Results posted Last updated 26 November 2021

What this trial tests

NA trial testing Virtual Reality device in Labor Pain in 40 participants. Terminated before completion.

Timeline

1 March 2018

Primary endpoint
19 February 2019

19 February 2019

Quick facts

Lead sponsor	Cedars-Sinai Medical Center
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 March 2018
Primary completion	19 February 2019
Estimated completion	19 February 2019
Sites	1 location across United States

Drugs / interventions tested

• Virtual Reality device

Conditions studied

• Labor Pain — all drugs for Labor Pain →
• Virtual Reality — all drugs for Virtual Reality →
• Alternative Medicine — all drugs for Alternative Medicine →

Sponsor

Cedars-Sinai Medical Center

Who can join

18 and older, female only, with Labor Pain or Virtual Reality. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Reduction in Pain Primary · 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.

Average Pain Score in 4 hours PRIOR to Intervention

Group	Value	95% CI
Latent-Control	3.39	0 – 7
Latent-VR	4.52	1.3 – 7

Pre-Intervention Pain score

Group	Value	95% CI
Latent-Control	5.05	4 – 7
Latent-VR	6	4 – 7

Post-Intervention Pain score

Group	Value	95% CI
Latent-Control	5.63	4 – 10
Latent-VR	5.48	0 – 8

Average Pain Score in 2 hours AFTER Intervention

Group	Value	95% CI
Latent-Control	5.44	4 – 7.5
Latent-VR	5	0 – 8

Average Pain Score in 4 hours AFTER Intervention

Group	Value	95% CI
Latent-Control	6.2	4.3 – 8.7
Latent-VR	5.48	1 – 8.5

Average Pain Score in 24 hours AFTER Intervention

Group	Value	95% CI
Latent-VR	3.36	2.75 – 4

Number of Participants With a Need for Intravenous Pain Medication Secondary · The total duration of the intervention (30 minutes)

IV pain medication during the intervention (yes/no)

Group	Value	95% CI
Latent-Control	0
Latent-VR	0

Need for Epidural During the Intervention Secondary · The total duration of the intervention (30 minutes)

Number of participants with need for an epidural during the intervention

Group	Value	95% CI
Latent-Control	0
Latent-VR	0

Childbirth Self-Efficacy Inventory Secondary · 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.

Group	Value	95% CI
Latent-Control	54.8	± 11.2
Latent-VR	52.6	± 11.8

Number of Participants With a Need for Epidural During the Labor Secondary · The total duration of the patient's labor (average 24 hours)

Epidural use during labor (yes/no)

Group	Value	95% CI
Latent-Control	17
Latent-VR	18

Sponsor's own 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 will perform a randomized controlled trial of patients in labor at Cedars-Sinai Medical Center.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Patient perceptions of virtual reality for pain relief in labor: A qualitative study.
   Wong MS, Gregory KD, Spiegel BMR, Khalil C. · · 2022 · cited 5× · PMID 36582195 · DOI 10.3389/fpain.2022.1063751