Analgesia Management for External Cephalic VersionNCT03588182
Virtual Reality for External Cephalic Version
A study testing Virtual Reality Experience in people with Analgesia Management for External Cephalic Version, run by Columbia University at 1 site in United States.
Trial summary
This will be a parallel design, nonblinded, randomized controlled superiority trial investigating the utility of a virtual reality (VR) experience to provide analgesia for external cephalic version (ECV). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia Management for External Cephalic Version
- What is being tested?
- Virtual Reality Experience
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2019to 6 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women, age >18 years, with a singleton pregnancy at >36 weeks gestational age, healthy (American Society of Anesthesiologists physical status class II), with an otherwise uncomplicated pregnancy (i.e. no fetal abnormalities or significant maternal morbidity, scheduled for ECV at CUMC with a plan to receive no anesthesia for the procedure.
Who cannot join
- 1) severe claustrophobia or other psychological/psychiatric disorder which would prevent the use of a VR headset; 2) history of severe motion sickness, which may lead to nausea and vomiting or other discomfort with use of the a VR headset; 3) severe visual impairment, which may prevent appreciation of the visual aspects of the VR environment presented; 4) severe auditory impairment, which may prevent full appreciation of the sounds presented in the VR environment; 5) facial skin or scalp open lesions which could be irritated or risk infection to the patient or others if the VR headset is used; 6) other viral/bacterial/fungal infectious illnesses that could easily be spread by sharing of the device e.g. viral or bacterial conjunctivitis, meningitis, influenza, common cold, and other upper respiratory tract infections; 7) severe or uncontrolled seizure disorder, as the VR experience could invoke seizures 8) bulky hairstyles which would significantly impair correct fitting of the VR headset.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Virtual Reality Analgesia for External Cephalic Version
This will be a parallel design, nonblinded, randomized controlled superiority trial investigating the utility of a virtual reality (VR) experience to provide analgesia for external cephalic version (ECV).
Read the detailed description
Subjects will be: Pregnant women, age >18 years, with a singleton pregnancy at >36 weeks gestational age, healthy (American Society of Anesthesiologists physical status class II), with an otherwise uncomplicated pregnancy (i.e. no fetal abnormalities or significant maternal morbidity, scheduled for ECV at Columbia University Irving Medical Center (CUIMC) with a plan to receive no anesthesia for the procedure.
Patients will be randomly assigned to either the VR or No VR group. The intervention will be provided for the duration of the ECV procedure (typically 15 - 30 mins).
- Being tested
- Virtual Reality Experience
- Keywords
- Virtual Reality (VR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality ExperienceOther
Virtual reality visualization and experience of a 3-dimensional relaxing nature scene with the accompanying audio.
| Study group | Role | What they receive |
|---|---|---|
| Group VR | Experimental | 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. Receives: Other: Virtual Reality Experience |
| Group No VR | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean maximal numerical rating scale (NRS) score ( scale 0 - 10) for pain during the ECV procedure.
Verbal rating of pain (scale 0 - 10) during ECV procedure, rated every 5 minutes
Measured: The maximal rated pain score will be determined within 5 minutes of the end of the ECV procedure.
Secondary outcomes (2)
Success of ECV procedure
The successful manipulation of the fetus from the breech to cephalic position
Measured: Within 5 minutes of the end of the ECV procedure
Rating of the likelihood of choosing the analgesia technique received again
Verbal rating of likelihood to choose the analgesia technique received again (scale 1 - 5, where 1 = I would not utilize again, 5 = I would definitely utilize again)
Measured: Within 2 hours of the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start18 May 2019
- Primary completion6 Dec 2023
- Study completion6 Dec 2023
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia Management for External Cephalic VersionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel design, nonblinded, randomized controlled superiority trial
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Lee, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588182
- Sponsor's protocol ID
- AAAR9073
- Status last verified
- May 2024
- First submitted
- 4 Jul 2018
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An excel spreadsheet with data will be available on request.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Analgesia for External Cephalic Version
- ClinicalTrials.gov ID
- NCT03588182
- Acronym / sponsor ID
- AAAR9073
- Keywords
- Virtual Reality (VR)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the institution
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 18 May 2019 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a parallel design, nonblinded, randomized controlled superiority trial investigating the utility of a virtual reality (VR) experience to provide analgesia for external cephalic version (ECV).
Detailed description
Subjects will be: Pregnant women, age >18 years, with a singleton pregnancy at >36 weeks gestational age, healthy (American Society of Anesthesiologists physical status class II), with an otherwise uncomplicated pregnancy (i.e. no fetal abnormalities or significant maternal morbidity, scheduled for ECV at Columbia University Irving Medical Center (CUIMC) with a plan to receive no anesthesia for the procedure.
Patients will be randomly assigned to either the VR or No VR group. The intervention will be provided for the duration of the ECV procedure (typically 15 - 30 mins).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel design, nonblinded, randomized controlled superiority trial
| Arm | Type | Receives |
|---|---|---|
| Group VR | Experimental | Other: Virtual Reality ExperienceVirtual 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 No VR | No 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women, age >18 years, with a singleton pregnancy at >36 weeks gestational age, healthy (American Society of Anesthesiologists physical status class II), with an otherwise uncomplicated pregnancy (i.e. no fetal abnormalities or significant maternal morbidity, scheduled for ECV at CUMC with a plan to receive no anesthesia for the procedure.
Key exclusion criteria (1 listed)
- 1) severe claustrophobia or other psychological/psychiatric disorder which would prevent the use of a VR headset; 2) history of severe motion sickness, which may lead to nausea and vomiting or other discomfort with use of the a VR headset; 3) severe visual impairment, which may prevent appreciation of the visual aspects of the VR environment presented; 4) severe auditory impairment, which may prevent full appreciation of the sounds presented in the VR environment; 5) facial skin or scalp open lesions which could be irritated or risk infection to the patient or others if the VR headset is used; 6) other viral/bacterial/fungal infectious illnesses that could easily be spread by sharing of the device e.g. viral or bacterial conjunctivitis, meningitis, influenza, common cold, and other upper respiratory tract infections; 7) severe or uncontrolled seizure disorder, as the VR experience could invoke seizures 8) bulky hairstyles which would significantly impair correct fitting of the VR headset.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality ExperienceVirtual reality visualization and experience of a 3-dimensional relaxing nature scene with the accompanying audio. | Other | Group VR |
Primary outcome
Mean maximal numerical rating scale (NRS) score ( scale 0 - 10) for pain during the ECV procedure.
Time frame: The maximal rated pain score will be determined within 5 minutes of the end of the ECV procedure.
Verbal rating of pain (scale 0 - 10) during ECV procedure, rated every 5 minutes
2 secondary outcomes
Success of ECV procedure
Time frame: Within 5 minutes of the end of the ECV procedure
Rating of the likelihood of choosing the analgesia technique received again
Time frame: Within 2 hours of the end of the procedure
Results and safety
The study was stopped early (reason given: PI left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: Yes. An excel spreadsheet with data will be available on request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Lee, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Experience in people with Analgesia Management for External Cephalic Version, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean maximal numerical rating scale (NRS) score ( scale 0 - 10) for pain during the ECV procedure. (time frame: The maximal rated pain score will be determined within 5 minutes of the end of the ECV procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.