Clinical trial

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

Name
BUCH 595
Description
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.
Trial arms
Trial start
2021-12-24
Estimated PCD
2022-09-20
Trial end
2022-09-20
Status
Completed
Treatment
breastfeeding
nonphamacological methods
Arms:
Breastfeeding intervention
Breastfeeding and Shotblocker
combined Breastfeeding and Shotblocker device
Arms:
Breastfeeding and Shotblocker intervention
shotblocker
it is a small plastic tool
Arms:
Shotblocker intervention
Size
160
Primary endpoint
Neonatal Infant Pain Scale (NIPS)
during the heel lance
The Newborn Comfort Behavior Scale (NEAS)
during the heel lance
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'attempt will be videotaped, outcome evaluators will be blind', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 160, 'type': 'ACTUAL'}}
Updated at
2023-03-06

1 organization

1 product

3 indications

Indication
Pain
Indication
Acute
Indication
Comfort