Effect of Three Different Sensory Interventions on Pain Level During Heel Blood Collection in Term Infant

NCT05526378 | Completed

• 1 other identifier: 2022/94
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Healthy newborns undergo many painful procedures in the first hours of life. Damage caused by painful procedures can lead to structural and functional changes that can affect adult life. Various non-pharmacological methods have been reported in the literature for pain management. The aim of the study is to investigate the effect of the method that appeals to 3 different senses (mother's voice, breast milk smell, mother's contact) on the level of pain during heel blood collection. Method: The population of the study consisted of babies who were hospitalized in a hospital's neonatal unit between December 2022 and May 2023 and who heel blood taken. The Neonatal-Infant Pain (NIPS) Scale and data collection form were used to obtain the data. 120 newborns who met the study criteria were randomly divided into group 1 (n=30) , group 2 (n=30), group 3 (n=30), control group (n=30). All intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. The mother called her baby between 40 and 60 decibels loudness for group 1. Breast milk was dripped onto the gauze in an amount to wet the entire 2,5cm\*2,5cm sterile gauze and the gauze was then placed close to the baby's nose wings for group 2. Skin-to-skin contact between mother and baby is provided for group 3. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure for all groups.

Conditions

Infant; Pain

Keywords

infant; pain; mother's milk; mother's voice; skin contact

Outcome Measures

Primary Outcomes (2)

• NIPS scale

  Neonatal Infant Pain Scale (NIPS) consists of 6 items (facial expression, crying, breathing pattern, arms, legs, alertness) and is evaluated between 0-7 points in total. As the score increases, the level of pain increases.

  Expecting during procedure

• NIPS scale

  Neonatal Infant Pain Scale (NIPS) consists of 6 items (facial expression, crying, breathing pattern, arms, legs, alertness) and is evaluated between 0-7 points in total. As the score increases, the level of pain increases.

  5 minutes after procedure

Study Arms (4)

Group 1 (mother's voice)

EXPERIMENTAL

The mother called her baby between 40 and 60 decibels loudness. The intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. Benetech brand GM1352 model decibel meter was used to measure the loudness.

Behavioral: Sensory Interventions

Group 2 (mother's milk)

EXPERIMENTAL

Breast milk was dripped onto the gauze in an amount to wet the entire 2,5cm\*2,5cm sterile gauze. The gauze was then placed close to the baby's nose wings. The intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure

Behavioral: Sensory Interventions

Group 3 (skin to skin contact)

EXPERIMENTAL

Skin-to-skin contact between mother and baby is provided. The intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure

Behavioral: Sensory Interventions

Control group

NO INTERVENTION

Interventions

Sensory Interventions BEHAVIORAL

Group 1 will be hear mother's voice before, during and after the procedure. Group 2 will be sniffed mother's breast milk before, during and after the procedure. Group 3 will be skin contact with mother's before, during and after the procedure.

Group 1 (mother's voice); Group 2 (mother's milk); Group 3 (skin to skin contact)

Eligibility Criteria

• Age: 24 Hours - 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Born between 37+0/7 - 41+6/7 gestational weeks,
• Gestational age and birth weight are compatible,
• Healthy newborns with stable vital signs.

You may not qualify if:

• Hearing problems,
• Suction problem
• Congenital anomaly,
• Need hospitalization in the neonatal intensive care unit.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (11)

• Lin CH, Liaw JJ, Chen YT, Yin T, Yang L, Lan HY. Efficacy of Breast Milk Olfactory and Gustatory Interventions on Neonates' Biobehavioral Responses to Pain during Heel Prick Procedures. Int J Environ Res Public Health. 2022 Jan 22;19(3):1240. doi: 10.3390/ijerph19031240.

  PMID: 35162263 BACKGROUND

• McPherson C, Miller SP, El-Dib M, Massaro AN, Inder TE. The influence of pain, agitation, and their management on the immature brain. Pediatr Res. 2020 Aug;88(2):168-175. doi: 10.1038/s41390-019-0744-6. Epub 2020 Jan 2.

  PMID: 31896130 BACKGROUND

• McNair C, Campbell-Yeo M, Johnston C, Taddio A. Nonpharmacologic Management of Pain During Common Needle Puncture Procedures in Infants: Current Research Evidence and Practical Considerations: An Update. Clin Perinatol. 2019 Dec;46(4):709-730. doi: 10.1016/j.clp.2019.08.006. Epub 2019 Aug 26.

  PMID: 31653304 BACKGROUND

• Zhang S, Su F, Li J, Chen W. The Analgesic Effects of Maternal Milk Odor on Newborns: A Meta-Analysis. Breastfeed Med. 2018 Jun;13(5):327-334. doi: 10.1089/bfm.2017.0226. Epub 2018 May 7.

  PMID: 29733222 BACKGROUND

• Benoit B, Newman A, Martin-Misener R, Latimer M, Campbell-Yeo M. The influence of breastfeeding on cortical and bio-behavioural indicators of procedural pain in newborns: Findings of a randomized controlled trial. Early Hum Dev. 2021 Mar;154:105308. doi: 10.1016/j.earlhumdev.2021.105308. Epub 2021 Jan 12.

  PMID: 33513546 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

• Yilmaz D, Yilmaz Kurt F. The effect of foot reflexology on procedural pain before heel lancing in neonates. Arch Pediatr. 2021 May;28(4):278-284. doi: 10.1016/j.arcped.2021.02.015. Epub 2021 Mar 11.

  PMID: 33715931 BACKGROUND

• Filippa M, Devouche E, Arioni C, Imberty M, Gratier M. Live maternal speech and singing have beneficial effects on hospitalized preterm infants. Acta Paediatr. 2013 Oct;102(10):1017-20. doi: 10.1111/apa.12356. Epub 2013 Aug 8.

  PMID: 23848529 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

• Filippa M, Monaci MG, Spagnuolo C, Serravalle P, Daniele R, Grandjean D. Maternal speech decreases pain scores and increases oxytocin levels in preterm infants during painful procedures. Sci Rep. 2021 Aug 27;11(1):17301. doi: 10.1038/s41598-021-96840-4.

  PMID: 34453088 BACKGROUND

• Duman R, Dogan E, Kaya HD, Tepe M. The Effect of Three Different Sensory Interventions (Mother's Voice, Mother's Milk, and Mother's Holding) During Heel Lance on Pain Level in Term Newborns: A Randomized Controlled Trial. Breastfeed Med. 2025 May;20(5):345-352. doi: 10.1089/bfm.2024.0197. Epub 2025 Feb 7.

  PMID: 39918942 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Elif Dogan

  Researcher Assistant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2022
• First Posted: September 2, 2022
• Study Start: December 22, 2022
• Primary Completion: April 15, 2023
• Study Completion: May 15, 2023
• Last Updated: October 18, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)