An interventional study of LaserPen in Procedural Pain, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 2 Days to 4 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-27.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Prevention
Neonates undergo several painful procedures and these pain experiences can alter clinical outcome and behavior. The investigators aim to investigate the analgesic effect of low level laser for procedural pain during heel lancing of term neonates.
This open-label, randomized controlled trial involves 130 term newborn infants (gestational ages between 37 weeks to 42 weeks) who need heel lancing for newborn screening. Subjects are randomly assigned to low level laser group or breast milk group. Subjects in breast milk group are given 5ml expressed breast milk by mouth using a syringe tube inserted to the participant's oral cavity over a 2-minute period. LaserPen is applied to the local point for 20 seconds where heel-lancing will be performed in the low level laser group. Then heel lancing is performed and two observers who are blinded to the intervention record the physiological (heart rate and oxygen saturation) and behavioral parameters (duration of crying and modified neonatal facial coding scores) following the procedure. Heart rate variation of participants is record by CheckMyHeart ECG monitor. The salivary swab method is used to detect the infant's salivary cortisol and amylase level as biomarker for stress evaluation. During the study course, digital cameras continuously record participants' behavior. Independent t-test, chi-squared test and one way ANOVA are used for statistical analysis.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's enrollment of 123 is above the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
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LaserPen is applied to the local point for 20 seconds where heel-lancing will be performed in the low level laser group.
Device: LaserPen
Subjects in breast milk group are given 5ml expressed breast milk by mouth using a syringe tube inserted to the participant's oral cavity over a 2-minute period before heel-lancing.
low level laser is used before heel-lancing for newborn screening
Also known as: power 150mW, wavelength 810nm, RJ-laser
pain assessment
latency of first cry, crying time, squeezing time, neonatal facial coding system(NFCS), Neonatal Pain, Agitation and Sedation Scale (NPASS)
Time frame: immediately after heel-lancing
stress biomarker
The salivary swab method is used to detect the infant's salivary cortisol and amylase level at 3 time point.
Time frame: baseline, immediately after heel-lancing, 20 minutes after heel-lancing
Plan to share: Undecided
Ran from Aug 2017 to primary completion in Jun 2019, 22 months.
Of 141 non-industry interventional studies with no phase under Pain, Procedural, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's 22 months is above that.
Counting every sponsor, half of 141 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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