Analgesia Management for External Cephalic Version Clinical Trial
Official title:
Virtual Reality Analgesia for External Cephalic Version
| NCT number | NCT03588182 |
| Other study ID # | AAAR9073 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 18, 2019 |
| Est. completion date | December 6, 2023 |
| Verified date | May 2024 |
| Source | Columbia University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | December 6, 2023 |
| Est. primary completion date | December 6, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 55 Years |
| Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Columbia University Irving Medical Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Columbia University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | The maximal rated pain score will be determined within 5 minutes of the end of the ECV procedure. | |
| Secondary | Success of ECV procedure | The successful manipulation of the fetus from the breech to cephalic position | Within 5 minutes of the end of the ECV procedure | |
| Secondary | 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) | Within 2 hours of the end of the procedure |