Your session is about to expire
← Back to Search
Other
Virtual Reality for Pain Management During ECV
N/A
Waitlist Available
Led By Allison Lee, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 5 minutes of the end of the ecv procedure
Awards & highlights
Study Summary
This trial will compare VR to no VR during ECV to see if VR is more effective at reducing pain.
Who is the study for?
This trial is for healthy pregnant women over 18, with a single baby at more than 36 weeks gestation, scheduled for an ECV without anesthesia. They must not have complications in pregnancy or severe health issues. Those with auditory or visual impairments, skin lesions on the face/scalp, bulky hairstyles, claustrophobia, history of motion sickness or seizures cannot participate.Check my eligibility
What is being tested?
The study tests if virtual reality can provide pain relief during external cephalic version (ECV), a procedure to turn breech babies before birth. It's a randomized trial where some will use VR as analgesia and others won't; participants are chosen randomly to each group.See study design
What are the potential side effects?
Potential side effects from using VR may include nausea and vomiting due to motion sickness, discomfort from wearing the headset with certain hairstyles or facial features, and possible seizure risk in susceptible individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the maximal rated pain score will be determined within 5 minutes of the end of the ecv procedure.
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.
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
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 Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,439 Previous Clinical Trials
2,447,707 Total Patients Enrolled
Allison Lee, MDPrincipal InvestigatorColumbia University
3 Previous Clinical Trials
207 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe vision problems that could affect my ability to see in a virtual reality setting.I do not have any contagious infections like the flu or a cold.I am a healthy pregnant woman over 18, past 36 weeks with a single baby, planning a specific procedure without anesthesia.I do not have open wounds on my face or scalp that could get infected by using a VR headset.I do not have severe or uncontrolled seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Group VR
- Group 2: Group No VR
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger