Clinical trial NCT06235723: Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic
Official title: Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Procedural Anxiety
Procedural Pain
Keywords: Virtual Reality
Pediatric Oncoloy
Outpatient Clinic
Peri-interventional Pain
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Procedural Pain measured with Numeric Rating Scale (NRS; scale 0-10; higher score stating higher levels of pain)
timeFrame: pre-, peri-, post-interventional (before puncture when entering intervention room, during puncture and 5 minutes after puncture)
measure: Procedural Anxiety measured with modified Yale Preoperative Anxiety Scale (mYPAS-SF; scale 23-100; higher score stating higher levels of anxiety)
timeFrame: pre-, peri-interventional (before puncture when entering intervention room and during puncture)
measure: Procedural Distress measured with Behavioral Approach Avoidance Distress Scale (BAADS; scale 0-10; higher score stating higher levels of distress)
timeFrame: pre-, peri-interventional (before puncture when entering intervention room and during puncture)
Secondary outcomes:
measure: Acceptance of VR in pediatric procedures (questionnaire using a 5-point-likert-scale)
timeFrame: post-interventional (immediately after the intervention)
measure: Implementation factors for VR in pediatric outpatient clinics (qualitive questionnaire)
timeFrame: through study completion, ~ 1.5 years in total
Other outcomes:
Locations:
city: Hanover
country: Germany
facility: Medical School Hanover
state: Lower Saxony
Study officials:
affiliation: Hannover Medical School
name: Urs Mücke, Dr.
role: PRINCIPAL_INVESTIGATOR
References: