Shotblocker and Breastfeeding on Pain/Comfort During Heel Lance

Pain, Acute Clinical Trial

— heellance  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05246787
• Other study ID #: BUCH 595
• Status: Completed
• Phase: N/A
• Start date: December 24, 2021
• Est. completion date: September 20, 2022

Study information

• Verified date: March 2023
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 10 Days

Eligibility

Inclusion Criteria:

• Birth week is between 34-42 weeks,

• Postnatal in the first 10 days

• Birth weight is between 2500-4000 grams,

• Stable general condition,

• Being with her mother and literate,

• Breastfeeding,

• Newborns of mothers who agreed to participate in the study

Exclusion Criteria:

• In need of oxygen support,

• Unsuccessful heel lance attempt, patients whose heel lance cannot be taken in 30 sec.(in groups with shotblocker)

• Needing parenteral nutrition,

• Receiving analgesic treatment,

• Having physical, metabolic and genetic diseases,

• Having a mental or mental health problem in the mother

• Non-breastfed newborns

• Newborns hospitalized in the 3rd and 4th level neonatal intensive care unit

Related Conditions & MeSH terms

• Acute Pain
• Comfort
• Pain, Acute

Intervention

Behavioral:
• breastfeeding
nonphamacological methods

Combination Product:
• Breastfeeding and Shotblocker
combined Breastfeeding and Shotblocker device

Device:
• shotblocker
it is a small plastic tool

Locations

Country	Name	City	State
Turkey	Dr. Behçet Uz Children Hospital	Izmir
Turkey	Gülçin Özalp Gerçeker	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Infant Pain Scale (NIPS)	Turkish validity and reliability were established. Reliability values were found to be 0.83, 0.83, 0.86 before, during and after the procedure, respectively. Newborn infant pain scale is a likert-type scale consisting of 6 parameters, facial movements (0; relaxed, 1; restless), crying (0; no crying, 1; groaning, 2; loud crying), breathing (0; comfortable, 1; variable-irregular), arm (0: relaxed-free, 1; flexion-extension), leg (0; comfortable-free, 1; flexion-extension) and sleep-wake (0; sleeping-waking peaceful, 1; restless).	during the heel lance
Primary	The Newborn Comfort Behavior Scale (NEAS)	The newborn comfort behavior scale is a Likert type scale developed to evaluate the comfort needs, pain and distress of newborn babies.his scale consists of six parameters: alertness, agitation, respiratory response/crying, body movements, facial tension and muscle tone.	during the heel lance