NCT06235723

Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic

Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Pain and anxiety-inducing interventions have a major impact on pediatric patients. Pain reduction by virtual reality (VR) during port and vein punctures is well studied. This study investigates peri-interventional reduction of pain, anxiety and distress using VR compared to the standard of care (SOC) in a pediatric oncology outpatient clinic. In a randomized, controlled cross-over design, patients aged 6-18 years experience potentially painful interventions accompanied by VR. All patients included in the study underwent port puncture or peripheral venous puncture in two observations : SOC (A) and VR (B) in a randomized order. Observational instruments include Numeral Rating Scale (NRS), Faces Pain Scale revised (FPS-r), Behavioral Approach Avoidance Distress Scale (BAADS), modified Yale Preoperative Anxiety Scale (mYPAS-SF). In addition, parents and staff are interviewed. Specific conditions for VR in an outpatient clinic setting are being discussed.

Conditions

• Pediatric Cancer
• Procedural Anxiety
• Procedural Pain

Interventions

Type	Name	Description
DEVICE	Virtual Reality	Virtual Reality was used before and during punctures. For every observation patients underwent either port puncture or peripheral venous puncture. One examination was carried out according to the Standard-of-Care. The other one was carried out with the additional use of VR. Participants watched a passive distraction video.

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-12-20
• Completion: 2023-12-20
• First posted: 2024-02-01
• Last updated: 2024-02-13

Locations

1 site across 1 country: Germany