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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
38
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.
Medical School Hanover
Hanover, Lower Saxony, Germany
Procedural Pain measured with Numeric Rating Scale (NRS; scale 0-10; higher score stating higher levels of pain)
Virtual Reality vs. Standard-of-Care
Time frame: pre-, peri-, post-interventional (before puncture when entering intervention room, during puncture and 5 minutes after puncture)
Procedural Anxiety measured with modified Yale Preoperative Anxiety Scale (mYPAS-SF; scale 23-100; higher score stating higher levels of anxiety)
Virtual Reality vs. Standard-of-Care
Time frame: pre-, peri-interventional (before puncture when entering intervention room and during puncture)
Procedural Distress measured with Behavioral Approach Avoidance Distress Scale (BAADS; scale 0-10; higher score stating higher levels of distress)
Virtual Reality vs. Standard-of-Care
Time frame: pre-, peri-interventional (before puncture when entering intervention room and during puncture)
Acceptance of VR in pediatric procedures (questionnaire using a 5-point-likert-scale)
Parents and patients were given different statements
Time frame: post-interventional (immediately after the intervention)
Implementation factors for VR in pediatric outpatient clinics (qualitive questionnaire)
Involved staff were asked about experience/feedback
Time frame: through study completion, ~ 1.5 years in total
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