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

NCT05444608 | Completed

• 1 other identifier: AnkaraU06BO
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Newborn; Pain; Breast milk odor; White noise; Heel lance

Outcome Measures

Primary Outcomes (2)

• Neonatal Pain

  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

  Physiological Findings Follow-up Chart

  up to 7 days

Study Arms (3)

Control Group

NO INTERVENTION

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.

Breast Milk Odor Group

EXPERIMENTAL

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

White Noise Group

EXPERIMENTAL

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

Interventions

Breast milk olfactory stimulation BEHAVIORAL

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.

Breast Milk Odor Group

White noise auditory stimulation BEHAVIORAL

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.

White Noise Group

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, Turkey (Türkiye)

Location

Related Publications (19)

• Akcan E, Polat S. Comparative Effect of the Smells of Amniotic Fluid, Breast Milk, and Lavender on Newborns' Pain During Heel Lance. Breastfeed Med. 2016 Aug;11(6):309-314. doi: 10.1089/bfm.2015.0174. Epub 2016 Jun 17.

  PMID: 27315487 BACKGROUND

• Alemdar DK. Effect of recorded maternal voice, breast milk odor, and incubator cover on pain and comfort during peripheral cannulation in preterm infants. Appl Nurs Res. 2018 Apr;40:1-6. doi: 10.1016/j.apnr.2017.12.001. Epub 2017 Dec 14.

  PMID: 29579482 BACKGROUND

• American Academy of Pediatrics Committee on Fetus and Newborn; American Academy of Pediatrics Section on Surgery; Canadian Paediatric Society Fetus and Newborn Committee; Batton DG, Barrington KJ, Wallman C. Prevention and management of pain in the neonate: an update. Pediatrics. 2006 Nov;118(5):2231-41. doi: 10.1542/peds.2006-2277.

  PMID: 17079598 BACKGROUND

• Baudesson de Chanville A, Brevaut-Malaty V, Garbi A, Tosello B, Baumstarck K, Gire C. Analgesic Effect of Maternal Human Milk Odor on Premature Neonates: A Randomized Controlled Trial. J Hum Lact. 2017 May;33(2):300-308. doi: 10.1177/0890334417693225. Epub 2017 Mar 27.

  PMID: 28346843 BACKGROUND

• Brummelte S, Grunau RE, Chau V, Poskitt KJ, Brant R, Vinall J, Gover A, Synnes AR, Miller SP. Procedural pain and brain development in premature newborns. Ann Neurol. 2012 Mar;71(3):385-96. doi: 10.1002/ana.22267. Epub 2012 Feb 28.

  PMID: 22374882 BACKGROUND

• Cakirli M, Acikgoz A. A Randomized Controlled Trial: The Effect of Own Mother's Breast Milk Odor and Another Mother's Breast Milk Odor on Pain Level of Newborn Infants. Breastfeed Med. 2021 Jan;16(1):75-81. doi: 10.1089/bfm.2020.0222. Epub 2020 Oct 20.

  PMID: 33085532 BACKGROUND

• Cetinkaya S, Yavas Celik M, Ozdemir S. Effect of white noise on alleviating the pain of new-born during invasive procedures. J Matern Fetal Neonatal Med. 2022 Apr;35(8):1426-1432. doi: 10.1080/14767058.2020.1755652. Epub 2020 Apr 21.

  PMID: 32316794 BACKGROUND

• Cignacco E, Hamers JP, Stoffel L, van Lingen RA, Gessler P, McDougall J, Nelle M. The efficacy of non-pharmacological interventions in the management of procedural pain in preterm and term neonates. A systematic literature review. Eur J Pain. 2007 Feb;11(2):139-52. doi: 10.1016/j.ejpain.2006.02.010. Epub 2006 Apr 3.

  PMID: 16580851 BACKGROUND

• Doesburg SM, Chau CM, Cheung TPL, Moiseev A, Ribary U, Herdman AT, Miller SP, Cepeda IL, Synnes A, Grunau RE. Neonatal pain-related stress, functional cortical activity and visual-perceptual abilities in school-age children born at extremely low gestational age. Pain. 2013 Oct;154(10):1946-1952. doi: 10.1016/j.pain.2013.04.009. Epub 2013 Apr 8.

  PMID: 23711638 BACKGROUND

• Dora O, Buyuk ET. RETRACTED: Effect of White Noise and Lullabies on Pain and Vital Signs in Invasive Interventions Applied to Premature Babies. Pain Manag Nurs. 2021 Dec;22(6):724-729. doi: 10.1016/j.pmn.2021.05.005. Epub 2021 Jun 28.

  PMID: 34210600 BACKGROUND

• Grunau RE, Holsti L, Peters JW. Long-term consequences of pain in human neonates. Semin Fetal Neonatal Med. 2006 Aug;11(4):268-75. doi: 10.1016/j.siny.2006.02.007. Epub 2006 Apr 24.

  PMID: 16632415 BACKGROUND

• Kahraman A, Gumus M, Akar M, Sipahi M, Bal Yilmaz H, Basbakkal Z. The effects of auditory interventions on pain and comfort in premature newborns in the neonatal intensive care unit; a randomised controlled trial. Intensive Crit Care Nurs. 2020 Dec;61:102904. doi: 10.1016/j.iccn.2020.102904. Epub 2020 Jul 9.

  PMID: 32653359 BACKGROUND

• Kucuk Alemdar D, Kardas Ozdemir F. Effects of Having Preterm Infants Smell Amniotic Fluid, Mother's Milk, and Mother's Odor During Heel Stick Procedure on Pain, Physiological Parameters, and Crying Duration. Breastfeed Med. 2017 Jun;12:297-304. doi: 10.1089/bfm.2017.0006. Epub 2017 Apr 17.

  PMID: 28414516 BACKGROUND

• Maayan-Metzger A, Kedem-Friedrich P, Bransburg Zabary S, Morag I, Hemi R, Kanety H, Strauss T. The Impact of Preterm Infants' Continuous Exposure to Breast Milk Odor on Stress Parameters: A Pilot Study. Breastfeed Med. 2018 Apr;13(3):211-214. doi: 10.1089/bfm.2017.0188. Epub 2018 Mar 12.

  PMID: 29620936 BACKGROUND

• Rad ZA, Aziznejadroshan P, Amiri AS, Ahangar HG, Valizadehchari Z. The effect of inhaling mother's breast milk odor on the behavioral responses to pain caused by hepatitis B vaccine in preterm infants: a randomized clinical trial. BMC Pediatr. 2021 Feb 1;21(1):61. doi: 10.1186/s12887-021-02519-0.

  PMID: 33522927 BACKGROUND

• Stevens BJ, Gibbins S, Yamada J, Dionne K, Lee G, Johnston C, Taddio A. The premature infant pain profile-revised (PIPP-R): initial validation and feasibility. Clin J Pain. 2014 Mar;30(3):238-43. doi: 10.1097/AJP.0b013e3182906aed.

  PMID: 24503979 BACKGROUND

• Taddio A, Shah V, Atenafu E, Katz J. Influence of repeated painful procedures and sucrose analgesia on the development of hyperalgesia in newborn infants. Pain. 2009 Jul;144(1-2):43-8. doi: 10.1016/j.pain.2009.02.012. Epub 2009 Mar 28.

  PMID: 19329255 BACKGROUND

• Taplak AS, Bayat M. Psychometric Testing of the Turkish Version of the Premature Infant Pain Profile Revised-PIPP-R. J Pediatr Nurs. 2019 Sep-Oct;48:e49-e55. doi: 10.1016/j.pedn.2019.06.007. Epub 2019 Jun 19.

  PMID: 31229348 BACKGROUND

• Otlu B, Esenay FI. Use of Mothers Milk Odor and White Noise on Pain Management in Preterm Infants: A Randomized Controlled Trial. Adv Neonatal Care. 2025 Feb 1;25(1):28-36. doi: 10.1097/ANC.0000000000001214. Epub 2024 Dec 16.

  PMID: 39681072 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A sponge soaked in saline was placed next to the babies listening to white noise, and a non-working loudspeaker was placed on the toe of the babies who smelled breast milk. The assessment was made by academics other than the researcher by muting the video recordings. The babies were considered blind because they did not know which group they were in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 6, 2022
• Study Start: May 16, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

TU (1)