Clinical trial NCT05444608: Premature Newborn Pain Management: The Effects of Breast Milk Odor and White Noise
Official title: Evaluation of the Effect of Use of Breast Milk Odor and White Noise on Pain Management During Heel Lance in Premature Newborns: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Newborn
Pain
Breast milk odor
White noise
Heel lance
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 66
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized controlled experimental study will performing to investigate the effect of smelling breast milk and listening to white noise in reducing pain during heel puncture
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will conduct to evaluate the effect of using white noise and breast milk odor on pain during heel lance procedure in premature newborns. This study is a randomized controlled trial.

The study will conduct with premature newborns who were born between 34 and 37 weeks of gestation. The premature newborns will be divided into three groups by application of pain relief methods during heel lance to check blood sugar in newborns. These groups can be described as breast milk odor (n=22), white noise (n=22) and control group (n=22). The intervention will start 5 minutes before the procedure and last 5 minutes after the procedure. The infants will be recorded with a video camera by researcher before, during, and after the procedure. Premature Infant Pain Profile Revised (PIPP-R) will be used for pain grading.

Detailed description: The sense of pain develops in infants after the 20th gestational weeks with the initiation of communication between the cortex and the thalamus. Babies in the newborn period can respond physiologically, behaviorally and hormonal to painful stimuli which they experienced. Responses that emerge as a result of pain experience may adversely affect the current state of the newborn and its growth and development in the long term. One of the painful procedures that the newborn is frequently exposed to at the beginning of the extra-uterine life is blood collection from the heel. Pharmacological and non-pharmacological methods can be applied to alleviate the pain sensation experienced by newborns during these procedures. The existence of possible side effects of pharmacological methods has led to need to use non-pharmacological methods more effectively. In this study, it was aimed to investigate the effectiveness of breast milk odor and white noise, which are non-pharmacological methods, to the pain caused by heel puncture.

Main hypothesizes of the study can be listed as:

H11: Breast milk smelling during heel lancing in preterm newborn infants effectively reduces the infant's procedure-related pain.

H01: Breast milk smelling during heel lancing in preterm newborn infants is not effective in reducing the procedure-related pain of the infant.

H12: Listening to white noise during heel lancing in preterm newborn babies effectively reduces the baby's procedure-related pain.

H02: Listening to white noise during heel lancing in preterm newborn infants is not effective in reducing the procedure-related pain of the infant.

H13: Breast milk smelling during heel puncture in preterm newborn infants is more effective than white noise in reducing the procedure-related pain of the infant.

H03: Breast milk smelling during heel puncture in preterm newborn infants is not more effective than white noise in reducing the procedure-related pain of the infant.

H14: Listening to white noise during heel lancing in preterm newborn babies is more effective than breast milk odor in reducing the procedure-related pain of the baby.

H04: Listening to white noise during heel lancing in preterm newborn babies is not more effective than breast milk odor in reducing the procedure-related pain of the infant.

The population of the study will consist of preterm babies born between 34-37 weeks of gestation, who were hospitalized in the Neonatal Intensive Care Unit mother-baby room, and postnatal service of Ankara University Faculty of Medicine, Cebeci Application and Research Hospital, between May 2022 and October 2022 and for whom heel blood sampling is requested.The sample of the study will consist of 66 (white noise=22, breast milk odor=22, control=22) infants who met the case selection criteria and were randomly assigned to groups. Babies will be made to listen to white noise or smell breast milk for 5 minutes before the heel blood collection procedure, during the procedure and 5 minutes after the procedure in accordance with the group they are involved. Only routine nursing care will be applied to the control group, no additional intervention. All the infants in three different groups will be recorded by video camera. Recording will start 5 minutes before the heel lance procedure and continue during the procedure and 5 minutes after the procedure. Pain assessments will be made by another researcher through video recordings. Newborns pain will evaluate with the PIPP-R pain scale 5 minutes before procedure (at the beginnings of intervention), 2 minutes before procedure, at the time of the procedure and 5 minutes after the procedure. Heart rate and oxygen saturation will be recorded at the same times.

Eligibility criteria: Inclusion Criteria:

* gestational age between 34 and 37 weeks
* birth weight over 1500 g
* Taking blood from the heel for the purpose of measuring blood sugar
* Starting feeding with breast milk
* Parental consent

Exclusion Criteria:

* Having a chromosomal abnormality
* Presence of neonatal seizures
* Presence of intracranial bleeding (grade III-IV)
* Presence of craniofacial malformation
* Presence of congenital hearing loss
* Babies with perinatal asphyxia
* Babies using sedatives, muscle relaxants and antiepileptics
* Babies whose mothers have a history of substance use

Primary outcomes:
measure: Neonatal Pain
timeFrame: up to 7 days
measure: Physiological Findings
timeFrame: up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
References:
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