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

NCT06235723 | Completed

• 1 other identifier: VirtualReality2023
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer; Procedural Anxiety; Procedural Pain

Keywords

Virtual Reality; Pediatric Oncoloy; Outpatient Clinic; Peri-interventional Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Acceptance of VR in pediatric procedures (questionnaire using a 5-point-likert-scale)

  post-interventional (immediately after the intervention)

• Implementation factors for VR in pediatric outpatient clinics (qualitive questionnaire)

  through study completion, ~ 1.5 years in total

Study Arms (2)

SOC (A)

NO INTERVENTION

SOC = Standard-of-Care

VR (B)

EXPERIMENTAL

VR = Virtual Reality

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

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.

VR (B)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• epilepsy
• coronary artery disease
• history of severe vertigo
• obstacles to putting on and wearing VR glasses
• lack of informed consent for study participation.

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Medical School Hanover

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (1)

• Reitze A, Voigt M, Klawonn F, Dusch M, Grigull L, Mucke U. Impact of virtual reality on peri-interventional pain, anxiety and distress in a pediatric oncology outpatient clinic: a randomized controlled trial. BMC Pediatr. 2024 Aug 3;24(1):501. doi: 10.1186/s12887-024-04952-3.

  PMID: 39097718 DERIVED

MeSH Terms

Conditions

Neoplasms; Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Urs Mücke, Dr.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: February 1, 2024
• Study Start: July 1, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)