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Virtual Reality Environment Using a Dome Screen for Procedural Pain in Young Children during Intravenous Placement: A Pilot Randomized Controlled Trial

Virtual Reality Environment Using a Dome Screen for Procedural Pain in Young Children during Intravenous Placement: A Pilot Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005691
Enrollment
20
Registered
2020-12-22
Start date
2019-05-24
Completion date
Unknown
Last updated
2021-01-06

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

Conditions

None listed

Interventions

Others(Virtual reality environment using a dome screen) : Control group: standard of care during the intravenous placement (no virtual reality environment using dome screen with animation provided).

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children aged 2 to 6 years who visit the pediatric emergency department of Seoul national university hospital who need venipuncture for diagnosis or treatment.

Exclusion criteria

Exclusion criteria: Children were excluded from the study if they needed urgent IV placement (e.g., due to an unstable hemodynamic condition or an altered mental status), had developmental disabilities or facial anomalies that made it difficult to apply the pain scale, and if their guardians had insufficient Korean language ability to understand the study protocol. Children for whom IV catheter insertion failed on the first attempt were also excluded from the study.

Design outcomes

Primary

MeasureTime frame
FLACC (Face, Legs, Activity, Cry, Consolability) scale;Average FLACC (Face, Legs, Activity, Cry, Consolability) scale at 3 time points (immediately after the child lies in the bed, when the tourniquet is applied, when the needle penetrates the skin)

Secondary

MeasureTime frame
Guardian’s satisfaction with the needle procedure (5-point Likert type questionnaire);Child's pain intensity rated by his/her guardian (5-point Likert type questionnaire);Child' anxiety rated by his/her guardian (5-point Likert type questionnaire)

Countries

Korea, Republic of

Contacts

Public ContactHa Lee

Seoul National University Hospital

Outcome results

None listed

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