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Effectiveness of Virtual Reality (VR) for Pain and Anxiety Reduction During the Placement of Peripheral Venous Catheters (pVK) in Children Aged 4-12 Years: A Randomized Controlled Pilot Study

Effectiveness of Virtual Reality (VR) for Pain and Anxiety Reduction During the Placement of Peripheral Venous Catheters (pVK) in Children Aged 4-12 Years: A Randomized Controlled Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00035942
Enrollment
60
Registered
2025-01-21
Start date
2024-08-07
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain and Anxiety Reduction During the Placement of Peripheral Venous Catheters

Interventions

Group 1: Group 1: Experimental Group (30 participants): Use of VR during peripheral venous catheter insertion Group 2: Group 2: Control Group (30 participants): No use of VR during peripheral venous c
standard distraction strategies such as "comfort positioning," distraction with books, phone, tablet, or by relatives or medical staff are applied.

Sponsors

Universitätsklinik für Kinder- und Jugendmedizin, Kinderzentrum Bethel, Universitätsklinikum OWL, Universität Bielefeld
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Elective patients of the University Clinic for Pediatric and Adolescent Medicine, Children’s Center Bethel, University Hospital OWL, Bielefeld University 2. Required insertion of a peripheral venous catheter for further intervention or diagnostic purposes 3. The participant is between 4-12 years old at the time of inclusion 4. The participant and at least one legal guardian speak and understand German

Exclusion criteria

Exclusion criteria: 1. Participants with visual, auditory, or cognitive impairments 2. Participants with an underlying epileptic condition 3. Participants with known needle phobia 4. Participants with skin, facial, or ear infections or injuries 5. Participants with migraines, dizziness, vomiting, or known motion sickness 6. Pediatric emergency patients

Design outcomes

Primary

MeasureTime frame
1. Pain assessment using a visual analogue scale (VAS) to assess pain perception on the Faces Pain Scale – Revised according to Hicks et al. immediately after the intervention. 1. Anxiety assessment using a visual analogue scale (VAS) to assess anxiety in children (Children's Fear Scale) (McMurtry, Noel, Chambers, & McGrath, 2011) immediately after the intervention.

Secondary

MeasureTime frame
Age of Participants, heart rate, blood pressure, respiratory rate, number of puncture attempts, puncture site, needle size, documentation of possible VR-related side effects, necessity of physical restraint and the number of people required for this, number and timing of previous blood draws and/or placements of peripheral venous catheters. In the Experimental Group: Satisfaction of guardians using a visual analog scale (VAS) to measure parental satisfaction (Net Promoter Score (NPS)): “How likely are you to recommend ‘Virtual Reality’ to friends or family members?” and through a parent satisfaction questionnaire (see Appendix: Patient Experience Questionnaire Parent). In the Experimental Group: Satisfaction of performing physicians using a visual analog scale (VAS) based on the Net Promoter Score (NPS) to assess physician staff satisfaction: “How likely are you to recommend ‘Virtual Reality’ to patients or colleagues?” and through a questionnaire (see Appendix: Physician Questionnaire, post-procedure).

Countries

Germany

Contacts

Public ContactDoortje Mehrtens

Universitätsklinik für Kinder- und Jugendmedizin, Kinderzentrum Bethel, Universitätsklinikum OWL, Universität Bielefeld

doortje.mehrtens@evkb.de+4952177278050

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026