VIrtual Reality; The effect on pain reduction during an External Version, a randomised controlled trial.

VIrtual Reality; The effect on pain reduction during an External Version, a randomised controlled trial. - VIREV

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54693

Enrollment

Registered

2020-07-21

Start date

2020-11-19

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pijn anxiety Pain

Interventions

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 e

Eligibility

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary outcome measures: Rate of successful ECV procedures Patient tolerability, feasibility and satisfaction of VR use (questionnaire)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)