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

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

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 Overview

• Status: Completed
• Conditions: Pediatric Cancer; Procedural Pain; Procedural Anxiety
• Intervention / Treatment: Device: Virtual Reality

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30625
      • Medical School Hanover

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: SOC (A); SOC = Standard-of-Care
Experimental: VR (B); VR = Virtual Reality	Device: Virtual 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Urs Mücke, Dr., Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: December 23, 2023
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Virtual Reality; Outpatient Clinic; Pediatric Oncoloy; Peri-interventional Pain
• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Anxiety Disorders; Pain, Procedural
• Other Study ID Numbers: VirtualReality2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No