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Completed

NCT Number: NCT05246787

Shotblocker and Breastfeeding on Pain/Comfort During Heel Lance

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.

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Key information

Conditions

Pain, Acute Acute Pain Behavior Breast Feeding Comfort Feeding Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 day–10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Behçet Uz Children Hospital, Izmir, Turkey (Türkiye)

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About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breastfeeding

Behavioral

nonphamacological methods

Breastfeeding and Shotblocker

Combination Product

combined Breastfeeding and Shotblocker device

ShotBlocker

Device

it is a small plastic tool

Primary outcomes

  1. Neonatal Infant Pain Scale (NIPS)

    Time frame: during the heel lance

    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).

  2. The Newborn Comfort Behavior Scale (NEAS)

    Time frame: during the heel lance

    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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Acronym: heellance

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 18, 2022
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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