Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05742971
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2023-02-09
Brief Title:
Virtual Reality the Effect on Pain Reduction During an External Version
Sponsor:
Zuyderland Medisch Centrum
Organization:
Zuyderland Medisch Centrum
Study Overview
Official Title:
Virtual Reality the Effect on Pain Reduction During an External Version a Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIREV
Brief Summary:
SUMMARY
Rationale The use of an external cephalic version ECV to rotate the fetus from a non-cephalic to cephalic presentation reduces the rate of caesarean section by approximately two-thirds in term pregnancies with breech presentation Reducing pain during external cephalic version can contribute to an increase in success rate and consequently reduce the number of cesarean sections Literature about the effectivity of virtual reality VR on acute pain reduction seems promising
Objective The primary objective of this study is to explore the effect of VR on pain during ECV Secondary objectives are the rate of successful ECV procedures and to explore tolerability feasibility and patient satisfaction of VR use
Study design The study concerns a non-blinded single centre randomised controlled trial
Study population Eligible women who fulfill the inclusion criteria and are scheduled for an external cephalic version in the Zuyderland Medical Centre location Heerlen
Intervention The study population will be randomly divided into the intervention group VR-group or the standard care group The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the external version additional to the usual standard care The participants randomised to the standard care group receive the usual standard care given during external version
Main study parametersendpoints The primary outcome is pain measured on a numeric rating scale NRS A total of 42 patients have to be included in each group This means that a total of 84 women will have to be included in the study
Nature and extent of the burden and risks associated with participation benefit and group relatedness Each participating woman is asked to complete a questionnaire after using VR and the degree of pain perception is questioned on the basis of a 0-10 score NRS The study population experiences a very small medical risk when participating to this study They can experience side-effects of VR for example dizziness or nausea and in rare cases epileptic insults
Rationale The use of an external cephalic version ECV to rotate the fetus from a non-cephalic to cephalic presentation reduces the rate of caesarean section by approximately two-thirds in term pregnancies with breech presentation Reducing pain during external cephalic version can contribute to an increase in success rate and consequently reduce the number of cesarean sections Literature about the effectivity of virtual reality VR on acute pain reduction seems promising
Objective The primary objective of this study is to explore the effect of VR on pain during ECV Secondary objectives are the rate of successful ECV procedures and to explore tolerability feasibility and patient satisfaction of VR use
Study design The study concerns a non-blinded single centre randomised controlled trial
Study population Eligible women who fulfill the inclusion criteria and are scheduled for an external cephalic version in the Zuyderland Medical Centre location Heerlen
Intervention The study population will be randomly divided into the intervention group VR-group or the standard care group The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the external version additional to the usual standard care The participants randomised to the standard care group receive the usual standard care given during external version
Main study parametersendpoints The primary outcome is pain measured on a numeric rating scale NRS A total of 42 patients have to be included in each group This means that a total of 84 women will have to be included in the study
Nature and extent of the burden and risks associated with participation benefit and group relatedness Each participating woman is asked to complete a questionnaire after using VR and the degree of pain perception is questioned on the basis of a 0-10 score NRS The study population experiences a very small medical risk when participating to this study They can experience side-effects of VR for example dizziness or nausea and in rare cases epileptic insults
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None