Shotblocker and Breastfeeding on Pain/Comfort During Heel Lance (heellance)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Comfort
• Intervention / Treatment: Behavioral: breastfeeding; Device: shotblocker; Combination product: Breastfeeding and Shotblocker

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.)

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35100
    • Gülçin Özalp Gerçeker
  • İzmir, Turkey
    • Dr. Behçet Uz Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breastfeeding intervention; The baby will be placed on the mother's lap 2 minutes before the procedure. 2 minutes before the heel lance, the mother starts to breastfeed her baby and continues to breastfeed throughout the procedure and until the last touch to baby. If necessary, the researcher may verbally warn the mother in a calm tone to continue breastfeeding throughout the procedure. During the resting period (last 2 minutes) after the blood draw is completed, the baby stays on the mother's lap.	Behavioral: breastfeeding; nonphamacological methods
Experimental: Shotblocker intervention; 2 minutes before the procedure, the baby will be placed on the mother's lap. ShotBlocker is a small plastic tool that is blunt, short, has many points in contact with the skin, does not contain drugs, is in the shape of a horseshoe, invasive interventions can be applied through the space in the middle. It is positioned on the skin before the invasive procedure. The investigator should make sure that the contact points touch the skin. Shotblocker is pressed firmly for 20 seconds before the intervention, it is pulled from the area and the heel is pierced with the lancet. After Shotblocker is applied to the skin, invasive intervention should be performed within 30 seconds and the protocol should be followed. During the resting period (last 2 minutes) after the heel lance is completed, the baby stays on the mother's lap.	Device: shotblocker; it is a small plastic tool
Experimental: Breastfeeding and Shotblocker intervention; The baby will be placed on the mother's lap 2 minutes before the procedure. 2 minutes before the heel lance, the mother starts to breastfeed her baby and continues to breastfeed throughout the procedure and until the last touch to baby. The investigator should make sure that the contact points touch the skin. Shotblocker is pressed firmly for 20 seconds before the intervention, it is pulled from the area and the heel is pierced with the lancet. After Shotblocker is applied to the skin, invasive intervention should be performed within 30 seconds and the protocol should be followed. During the resting period (last 2 minutes) after the heel lance is completed, the baby stays on the mother's lap.	Combination product: Breastfeeding and Shotblocker; combined Breastfeeding and Shotblocker device
No Intervention: Control group/ Standard Care; The baby is placed on the mother's lap 2 minutes before the procedure and the mother is provided to hold the baby effectively and graspingly. Standard heel lance procedure is applied. No additional interventions are applied to the baby. During the resting period (last 2 minutes) after the heel lance is completed, the baby stays on the mother's lap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Principal Investigator: Gülçin Özalp Gerçeker, pHD, RN, PhD, Assoc. Prof.

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2021
• Primary Completion (Actual): September 20, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: breastfeeding; shotblocker
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: BUCH 595

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No