The effect of virtual reality on anxiety and pain in patients undergoing gynecological surgery: a randomised controlled trial

Completed

Conditions: Pijn en angstreductie
Pain and anxiety

Registration Number: NL-OMON49469

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 256

Inclusion Criteria

• Written and orally given informed consent
• 18 years and older
• Native Dutch speaker
• Indication for elective gynecological surgery

Exclusion Criteria

• Chronic pain patients; defined as *persistent or recurrent pain lasting
longer than 3 months* . The pain is not due to the gynecological problem.
• Chronical use of pain medication (opioids)
• History of prior opioid use defined as use within 8 to 90 days prior to the
surgical procedure
• Alcohol or drug abuse
• Known car sickness
• Epileptic insults in previous history
• Psychotically seizures in previous history
• Claustrophobic
• Blindness
• History of mental illness

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters: The primary outcome is postoperative pain measured on a<br /><br>numeric rating scale (NRS). To achieve a reduction of 15% in NRS score<br /><br>postoperative (alpha 0.05 and beta 0.20) and taken 15% lost to follow up into<br /><br>account, a total of 128 patients have to be included in each group. And a<br /><br>total of 256 women will have to be included in the study. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s):<br /><br>• Pre-operative anxiety (State-Trait Anxiety Inventory (STAI)-6 questionnaire)<br /><br>• Pain catastrophizing (Pain Catastrophizing Scale questionnaire)<br /><br>• Analgesic use (daily use of paracetamol, NSAIDs, opioids)<br /><br>• Length of hospital stay<br /><br>• Tolerability, feasibility and satisfaction of VR use (questionnaire)<br /><br>• Pre-operative pain score (NRS)</p><br>