Pediatric Cancer, Procedural Anxiety, Procedural Pain
Conditions
Keywords
Virtual Reality, Pediatric Oncoloy, Outpatient Clinic, Peri-interventional Pain
Brief 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.
Interventions
DEVICEVirtual 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.
Sponsors
Hannover Medical School
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* aged 6-18 years * any sex * port puncture or placement of a peripheral venous catheter in pediatric outpatient clinic * hematological or oncological diagnosis * informed consent
Exclusion criteria
* epilepsy * coronary artery disease * history of severe vertigo * obstacles to putting on and wearing VR glasses * lack of informed consent for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Pain measured with Numeric Rating Scale (NRS; scale 0-10; higher score stating higher levels of pain) | pre-, peri-, post-interventional (before puncture when entering intervention room, during puncture and 5 minutes after puncture) | Virtual Reality vs. Standard-of-Care |
| Procedural Anxiety measured with modified Yale Preoperative Anxiety Scale (mYPAS-SF; scale 23-100; higher score stating higher levels of anxiety) | pre-, peri-interventional (before puncture when entering intervention room and during puncture) | Virtual Reality vs. Standard-of-Care |
| Procedural Distress measured with Behavioral Approach Avoidance Distress Scale (BAADS; scale 0-10; higher score stating higher levels of distress) | pre-, peri-interventional (before puncture when entering intervention room and during puncture) | Virtual Reality vs. Standard-of-Care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance of VR in pediatric procedures (questionnaire using a 5-point-likert-scale) | post-interventional (immediately after the intervention) | Parents and patients were given different statements |
| Implementation factors for VR in pediatric outpatient clinics (qualitive questionnaire) | through study completion, ~ 1.5 years in total | Involved staff were asked about experience/feedback |
Countries
Germany
Outcome results
None listed