The primary objective of this study is to explore the effect of VR on pain during ECV. Secondary objectives are the rate of succesful ECV procedures and tot explore tolerability, faesibility and patient satisfaction of VR use.
ID
Source
Brief title
Condition
- Other condition
- Maternal complications of pregnancy
Synonym
Health condition
Pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primairy outcome is pain measured on a numeric rating scale (NRS). A total
of 40 patiënts have to be included in each group. This means that a total of 80
women will have to be included in the study.
Secondary outcome
Secondary outcome measures:
Rate of successful ECV procedures
Patient tolerability, feasibility and satisfaction of VR use (questionnaire)
Background summary
The use of an externale 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 succes
rate and consequently reduce the number of cesarean sections. Literature about
the effectivity of virtual reality (VR) on acute pain reduction seems
promising.
Study objective
The primary objective of this study is to explore the effect of VR on pain
during ECV. Secondary objectives are the rate of succesful ECV procedures and
tot explore tolerability, faesibility and patient satisfaction of VR use.
Study design
The study concerns a non-blinded, single centre, randomised controlled trial.
Intervention
The study population will be randomly divided into the intervention group (VR
group) or the standard care group. The intervention group gets an immersive
guided relaxation VR experience during the external version additional to the
usual standard carde. The participants randomised to the standard care group
receive the usual standard care given during external version.
Study burden and risks
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 in rare cases epileptic insults.
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Inclusion criteria
Written and orally given informed consent
18 years and older
Native Dutch speaker
Singleton pregnancy in breech position
Scheduled ECV
Exclusion criteria
Contra-indication external version
Chronic pain patients defined as persistent or recurrent pain lasting longer
than 3 months, The pain is no due to an obstetrical problem.
Chronic use of pain medication (opioids)
Alcohol or drug abuse
Known car sickness
Epileptic insults in previous history
Psychotically seizures in previous history
claustophobic
blindness
history of mental illness
patients in strict isolation (MRSA)
Age<18 years
Twin pregnancy
No native Dutch speaker
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71484.096.19 |