Premature Newborn Pain Management: The Effects of Breast Milk Odor and White Noise

November 20, 2023 updated by: Burcu Otlu, Ankara University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Data will be collected during heel blood sampling for blood sugar control from newborns randomly assigned to the control group. Babies in the control group will not be allowed to smell breast milk or listen to white noise.The newborn in the control group will continue to receive routine care.Camera recording will start 5 minutes before the procedure and lasting 5 minutes after the procedure.
Experimental: White Noise Group
Data will be collected during heel blood sampling for blood sugar control from newborns randomly assigned to the white noise listening group.Before the intervention , a bluetooth speaker will be placed at the baby's feet. The speaker will be connected to the phone and the sound level will be adjusted to 50 decibels by means of a decibel meter. The baby will be started to listen to white noise 5 minutes before the procedure.Camera recording will start 5 minutes before the procedure and lasting 5 minutes after the procedure.
Behavioral: White noise auditory stimulation
Before the intervention, a bluetooth speaker will be placed at the baby's feet. The speaker will be connected to the phone and the sound level will be adjusted to 50 decibels by means of a decibel meter. The baby will be started to listen to white noise 5 minutes before the procedure and will continue to listen for 5 minutes after the procedure.
Experimental: Breast Milk Odor Group
Data will be collected during heel blood sampling for blood sugar control from newborns randomly assigned to the breast milk odor group.Before the intervention, 2 ml of breast milk will be dripped into sterile sponge and the sponge will be placed within 3 cm of the newborn's nose.Babies in this group will start to smell their mother's milk 5 minutes before the procedure and will continue to smell for 5 minutes after the procedure.Camera recording will start 5 minutes before the procedure and lasting 5 minutes after the procedure.
Behavioral: Breast milk olfactory stimulation
Before the intervention, 2 ml of breast milk will be dripped into sterile sponge and the sponge will be placed within 3 cm of the newborn's nose.Babies in this group will start to smell their mother's milk 5 minutes before the procedure and will continue to smell for 5 minutes after the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Pain
Time Frame: up to 7 days

Premature Infant Pain Profile-Revised

The scale includes seven criteria. Facial expressions (frown, squint, prominence of the nasolabial groove) represent three criteria. Two additional criteria are changes in heart rate and reduction in oxygen saturation. The remaining criteria are gestational week and behavioral status (active-awake, quiet-wake, active-asleep and quiet-sleeping). According to the scale, the highest score is 21 for prematures and 18 for term newborns. According to the scale scoring, 0-6 points indicate mild pain, 7-12 points moderate pain, and 13-21 points severe pain in a premature baby.
up to 7 days
Physiological Findings
Time Frame: up to 7 days
Physiological Findings Follow-up Chart
up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2022

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

July 2, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraU06BO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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