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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06235723
Other study ID # VirtualReality2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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