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

Hannover Medical School (MHH)

Status: Completed

Conditions: Procedural Anxiety; Pediatric Cancer; Procedural Pain

Treatments: Device: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT06235723

VirtualReality2023

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

SOC (A)

No Intervention group

Description:

SOC = Standard-of-Care

VR (B)

Experimental group

Description:

VR = Virtual Reality

Treatment:

Device: Virtual Reality