Clinical trial NCT05742971: Virtual Reality; the Effect on Pain Reduction During an External Version.
Official title: Virtual Reality; the Effect on Pain Reduction During an External Version, a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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 parameters/endpoints: 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.


Eligibility criteria: Inclusion Criteria:

* Written and orally given informed consent
* 18 years and older
* Native Dutch speaker
* Singleton pregnancy in breech position
* Scheduled ECV

Exclusion Criteria:

* Contraindication for ECV
* Chronic pain patients defined as 'persistent or recurrent pain lasting longer than 3 months' \[16\]. The pain is not 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
* Claustrophobic
* Blindness
* History of mental illness
* Patients in strict isolation (MRSA)
* Age \<18 years
* Twin pregnancy
* No native Dutch speaker

Primary outcomes:
measure: Change of pain during ECV when using VR (VAS, visual analogue scale)
timeFrame: 15 minutes
Secondary outcomes:
measure: Rate of successful ECV procedures
timeFrame: 15 minutes
measure: Patient tolerability, feasibility and satisfaction of VR use (questionnaire)
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderaland MC
Study officials:
affiliation: Zuyderland MC
name: M Wassen, Dr
role: PRINCIPAL_INVESTIGATOR
References: