Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic

Not Applicable

Completed

• Conditions: Procedural Anxiety; Pediatric Cancer; Procedural Pain
• Interventions: Device: Virtual Reality

• Registration Number: NCT06235723
• Lead Sponsor: Hannover Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2022-12-20
• Study Completion: 2023-12-20
• Study First Submitted: 2023-12-23
• Study First Submitted QC: 2024-01-23
• Status Verified: 2024-02
• Study First Posted: 2024-02-01
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VR (B)	Virtual Reality	VR = Virtual Reality

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Medical School Hanover; 🇩🇪 Hanover, Lower Saxony, Germany