VIrtual Reality; The effect on pain reduction during an External Version, a randomised controlled trial.
Recruiting
- Conditions
- Pijn10026908anxietyPain
- Registration Number
- NL-OMON54693
- Lead Sponsor
- Zuyderland Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 84
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primairy outcome is pain measured on a numeric rating scale (NRS). A total<br /><br>of 40 patiënts have to be included in each group. This means that a total of 80<br /><br>women will have to be included in the study. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures:<br /><br>Rate of successful ECV procedures<br /><br>Patient tolerability, feasibility and satisfaction of VR use (questionnaire)</p><br>