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

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06235723
• Other study ID #: VirtualReality2023
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 20, 2023

Study information

• Verified date: February 2024
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Pain, Procedural
• Pediatric Cancer
• Procedural Anxiety
• Procedural Pain

Intervention

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.

Locations

Country	Name	City	State
Germany	Medical School Hanover	Hanover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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