Ear plugs helpful for children admitted to an intensive care?

Ear plugs in the PICU to reduce noise: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22537

Enrollment

Registered

2017-04-28

Start date

2017-05-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Stress caused by noise

Interventions

Wearing earplugs during busy periods in the PICU.

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: - Expected length of stay in PICU of at least 2 nights - Parental consent and if possible assent of the child from the age of twelve

Exclusion criteria

Exclusion criteria: Exclusion criteria: - Severe deafness

Design outcomes

Primary

Measure	Time frame
Change in COMFORT-B score between before and after the intervention.	—

Secondary

Measure	Time frame
Heart rate, incidence of delirium, use of sedatives and sleep pattern. Delirium will be assessed with the SOS-PD.	—

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)