Medical School Hanover
Hanover, Lower Saxony, 30625, Germany
NCT Number: NCT06235723
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.
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Notify Me6 year–18 year
All sexes
Interventional
Not applicable
Hanover, Lower Saxony, 30625, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: pre-, peri-, post-interventional (before puncture when entering intervention room, during puncture and 5 minutes after puncture)
Virtual Reality vs. Standard-of-Care
Time frame: pre-, peri-interventional (before puncture when entering intervention room and during puncture)
Virtual Reality vs. Standard-of-Care
Time frame: pre-, peri-interventional (before puncture when entering intervention room and during puncture)
Virtual Reality vs. Standard-of-Care
Time frame: post-interventional (immediately after the intervention)
Parents and patients were given different statements
Time frame: through study completion, ~ 1.5 years in total
Involved staff were asked about experience/feedback
Hannover Medical School
Other
Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic: a Randomized Controlled Trial
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