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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.
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,779 Total Patients Enrolled
Allison Lee, MDPrincipal InvestigatorColumbia University
3 Previous Clinical Trials
207 Total Patients Enrolled
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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.
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
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