Other

Virtual Reality Experience for Analgesia Management

Columbia University Irving Medical Center, New York, NY
Virtual Reality ExperienceN/AWaitlist AvailableLed by Allison Lee, MDResearch Sponsored by Columbia University

Study Summary

This trial will compare VR to no VR during ECV to see if VR is more effective at reducing pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the maximal rated pain score will be determined within 5 minutes of the end of the ecv procedure.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the maximal rated pain score will be determined within 5 minutes of the end of the ecv procedure. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean maximal numerical rating scale (NRS) score ( scale 0 - 10) for pain during the ECV procedure.
Secondary outcome measures
Rating of the likelihood of choosing the analgesia technique received again
Success of ECV procedure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group VRExperimental Treatment1 Intervention
Virtual reality (VR) experience VR visualization of a 3-dimensional relaxing nature scene with the accompanying audio. The patient will be offered a selection of scenes from which to choose, played continuously on a Samsung Gear VRTM(San Jose, CA) headset and headphones. The goal is for the patient to use the intervention for the entire duration of the external cephalic version procedure (ECV), which typically lasts 15 - 30 minutes.The patient will also receive verbal reassurance and coaching as needed. The obstetrician will communicate as usual with the patient.
Group II: Group No VRActive Control1 Intervention
No intervention will be provided for the control group, who will receive usual management at CUMC, which involves provision of no analgesia or sedation for the procedure, which typically lasts 15 - 30 minutes. Verbal reassurance and coaching is routinely provided by caregivers, including encouraging deep breathing, particularly during painful manipulation of the abdomen, for the duration of the procedure. The obstetrician will communicate as usual with the patient - for example advising that he/she is about to begin the procedure and giving updates as to the degree of success.

Find a site

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,381 Previous Clinical Trials
1,836,056 Total Patients Enrolled
Allison Lee, MDPrincipal Investigator
Columbia University
3 Previous Clinical Trials
207 Total Patients Enrolled

Media Library

Virtual Reality Experience (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03588182 — N/A
Analgesia Management Research Study Groups: Group VR, Group No VR
Analgesia Management Clinical Trial 2023: Virtual Reality Experience Highlights & Side Effects. Trial Name: NCT03588182 — N/A
Virtual Reality Experience (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03588182 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the demographic for this particular study limited to those aged 60 and over?

"Eligibility for this trial has an upper age limit of 55 and a lower age requirement of 18."

Answered by AI

Is it possible to partake in this clinical research?

"Eligible participants for this analgesia trial include singleton pregnant women aged 18-55 years, who are class II according to the American Society of Anesthesiologists physical status scale and without any fetal or maternal complications. The study is conducted at Columbia University Medical Centre with patients receiving no anesthesia during external cephalic version."

Answered by AI

Are there any current vacancies in this clinical trial?

"The particulars on clinicaltrials.gov elucidate that, despite initially being posted in May 18th 2019 and recently edited on the 2nd of May 2022, this trial is no longer seeking participants. That said, there are 1 other studies currently recruiting patients at this juncture."

Answered by AI
~4 spots leftby Apr 2024