Clinical trial NCT05246787: Shotblocker and Breastfeeding on Pain/Comfort During Heel Lance
Official title: The Effect of the Shotblocker and Breastfeeding on Pain and Comfort Level During Heel Lance Procedure in Newborns: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Comfort
Keywords: breastfeeding
shotblocker
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 160
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.)

Eligibility criteria: 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

Primary outcomes:
measure: Neonatal Infant Pain Scale (NIPS)
timeFrame: during the heel lance
measure: The Newborn Comfort Behavior Scale (NEAS)
timeFrame: during the heel lance
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gülçin Özalp Gerçeker
city: İzmir
country: Turkey
facility: Dr. Behçet Uz Children Hospital
Study officials:
affiliation: RN, PhD, Assoc. Prof.
name: Gülçin Özalp Gerçeker, pHD
role: PRINCIPAL_INVESTIGATOR
References: