|- candidate number||27142|
|- NTR Number||NTR6416|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-apr-2017|
|- Secondary IDs||MEC-2017-219 METC|
|- Public Title||Ear plugs helpful for children admitted to an intensive care?|
|- Scientific Title||Ear plugs in the PICU to reduce noise: a randomized controlled trial|
|- hypothesis||We hypothesize that wearing earplugs on busy periods in the PICU can reduce the level of distress. |
|- Healt Condition(s) or Problem(s) studied||Stress|
|- 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:|
- Severe deafness
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2017|
|- planned closingdate|
|- Target number of participants||64|
|- Interventions||Wearing earplugs during busy periods in the PICU.|
|- Primary outcome||Change in COMFORT-B score between before and after the intervention.|
|- Secondary outcome||Heart rate, incidence of delirium, use of sedatives and sleep pattern. |
Delirium will be assessed with the SOS-PD.
|- Timepoints||The patients will wear the earplugs three periods a day: 8.00-10.00, 14.00-16.00, 18.00-20,00.|
- COMFORT-B score: before and after each period of wearing the earplugs.
- Heart rate: before and after each period of wearing the earplugs.
- All other secondary outcomes: three times a day by the care giving nurse.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| |
|- CONTACT for SCIENTIFIC QUERIES|| |
|- Sponsor/Initiator ||Prof. dr. D. Tibboel|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Sophia Children's Hospital|
|- Brief summary||Rationale: Wearing earplugs during noisy periods in the Intensive Care Unit have shown a positive effect in neonates and adults. Evidence in critically ill children is lacking. |
Objective: To determine the effect of using earplugs during busy hours in the PICU on level of distress assessed with the COMFORT-B scale.
Study design: Open randomized control trial, stratified by age group.
Study population: Children from 0 to 18 years with the expectation of at least two nights admitted to the PICU.
Intervention: The intervention group wears earplugs during three standard periods of the day with peak intensity of noise and activity in the PICU.
Main study parameters/endpoints: 1) Difference in COMFORT-behaviour score before and after the intervention. 2) Heart rate before, during and after the intervention. 3) Incidence and duration of delirium in intervention group compared with the control group. 4) Use of sedatives in intervention group and control group. 5) Sleep pattern.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants will be visited six times a day. The intervention group will not experience more burden than wearing earplugs three times a day and have six site visits each day by the researcher to insert or remove the earplug. The researcher will measure the COMFORT-B score at the same site visits.
According to research in neonates and adults, earplugs have a positive effect on vital signs and delirium, so we expect these effects for the current intervention group as well. This current study needs to be done in this population because the lack of research about earplugs in this population.
|- Main changes (audit trail)|
|- RECORD||28-apr-2017 - 25-jun-2017|