NCT05246787

Shotblocker and Breastfeeding on Pain/Comfort During Heel Lance

The Effect of the Shotblocker and Breastfeeding on Pain and Comfort Level During Heel Lance Procedure in Newborns: Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Dokuz Eylul University · Academic / Other
• Sex: All
• Age: 1 Day – 10 Days
• Healthy volunteers: Not accepted

Summary

Shotblocker and breastfeeding are an attempt to reduce pain during invasive procedures in newborns. This study was planned to evaluate the effect of non-pharmacological interventions on the pain and comfort level of newborns, whose heel blood will be taken in the 1st Level Neonatal Intensive Care Unit.

Detailed description

Hypotheses H1: Newborns who undergo breastfeeding attempt during heel lance procedure feel less pain and have a higher comfort level. H2: Newborns who undergo breastfeeding attempt and are applied shotblocker during heel lance procedure feel less pain and have a higher comfort level. H3: Newborns who undergo shotblocker intervention during heel lance procedure feel less pain and have a higher comfort level. H4: There are a difference between the comfort levels, HR and PO2 of newborns in terms of group, group-time and time according to the intervention applied. Data collection process Mothers of newborns whose heel blood will be taken will be informed about the research. Consent will be obtained from the mother regarding the video recording during the heel lance precedure. After informed consent is obtained, it will be determined which group the newborn belongs to by stratified randomization. A standard approach will be applied to all newborns. Standard approach involves performing the heel lance procedure on the caregiver's lap. Heel lance procedure will be scheduled between 09:00 and 10:00 in the morning, one hour after babies are breastfed. Babies to be included in the study in each group; they will be in their beds, in the undisturbed rest period, until 30 minutes before the start of the test. All babies; 2 minutes before, during and up to 2 minutes after blood collection; they will be video-recorded including their heart rate, faces, and upper and lower extremities (especially the heel to be operated). No additional care will be given to ensure physiological stability during each intervention (breastfeeding, shotblocker, etc.)

Conditions

• Pain, Acute
• Comfort

Interventions

Type	Name	Description
BEHAVIORAL	breastfeeding	nonphamacological methods
COMBINATION_PRODUCT	Breastfeeding and Shotblocker	combined Breastfeeding and Shotblocker device
DEVICE	shotblocker	it is a small plastic tool

Timeline

• Start date: 2021-12-24
• Primary completion: 2022-09-20
• Completion: 2022-09-20
• First posted: 2022-02-18
• Last updated: 2023-03-06

Locations

2 sites across 1 country: Turkey (Türkiye)