Pediatric Cancer Clinical Trial
Official title:
Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic: a Randomized Controlled Trial
Verified date | February 2024 |
Source | Hannover Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | December 20, 2023 |
Est. primary completion date | December 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Medical School Hanover | Hanover | Lower Saxony |
Lead Sponsor | Collaborator |
---|---|
Hannover Medical School |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedural Pain measured with Numeric Rating Scale (NRS; scale 0-10; higher score stating higher levels of pain) | Virtual Reality vs. Standard-of-Care | pre-, peri-, post-interventional (before puncture when entering intervention room, during puncture and 5 minutes after puncture) | |
Primary | 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 | pre-, peri-interventional (before puncture when entering intervention room and during puncture) | |
Primary | 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 | pre-, peri-interventional (before puncture when entering intervention room and during puncture) | |
Secondary | Acceptance of VR in pediatric procedures (questionnaire using a 5-point-likert-scale) | Parents and patients were given different statements | post-interventional (immediately after the intervention) | |
Secondary | Implementation factors for VR in pediatric outpatient clinics (qualitive questionnaire) | Involved staff were asked about experience/feedback | through study completion, ~ 1.5 years in total |
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