Shotblocker and Breastfeeding on Pain/Comfort During Heel Lance

NCT05246787 | Completed DMC

• 1 other identifier: BUCH 595
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pain, Acute; Comfort

Keywords

breastfeeding; shotblocker

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Breastfeeding intervention

EXPERIMENTAL

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

Shotblocker intervention

EXPERIMENTAL

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

Breastfeeding and Shotblocker intervention

EXPERIMENTAL

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

Control group/ Standard Care

NO INTERVENTION

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.

Interventions

breastfeeding BEHAVIORAL

nonphamacological methods

Breastfeeding intervention

Breastfeeding and Shotblocker COMBINATION_PRODUCT

combined Breastfeeding and Shotblocker device

Breastfeeding and Shotblocker intervention

shotblocker DEVICE

it is a small plastic tool

Shotblocker intervention

Eligibility Criteria

• Age: 1 Day - 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (2)

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

Location

Dr. Behçet Uz Children Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

• Dinc C, Gerceker GO, Kalkanli O. The effect of the ShotBlocker(R) and breastfeeding on pain and comfort level during heel lance procedure in newborns: randomized controlled trial. Intensive Crit Care Nurs. 2025 Dec;91:104164. doi: 10.1016/j.iccn.2025.104164. Epub 2025 Jul 26.

  PMID: 40716331 DERIVED

MeSH Terms

Conditions

Acute Pain; Breast Feeding

Interventions

Lactation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Gülçin Özalp Gerçeker, pHD

  RN, PhD, Assoc. Prof.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: attempt will be videotaped, outcome evaluators will be blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 18, 2022
• Study Start: December 24, 2021
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)