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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49469
Enrollment
256
Registered
2020-02-20
Start date
2020-10-20
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 en angstreductie Pain and anxiety

Interventions

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 V

Sponsors

Zuyderland Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)