The Effect of Mother's Smell and Breast Milk Smell on Pain

NCT06323551 | Completed

• 1 other identifier: 2023/50
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The research was planned as a randomized controlled study to investigate the effect of breast milk smell and mother's smell applied while heel blood was taken to term babies in the Mersin City EAH Neonatal Intensive Care Unit between October and December 2023, on acute pain and crying duration. During the heel prick procedure, which is routinely performed in the neonatal intensive care unit, no pharmacological/non-pharmacological method will be applied to the control group to reduce the baby's pain before, during and after the heel prick. The baby's pain score will be evaluated by the observing nurse according to the NIPS pain scale 5 minutes before, during and 5 minutes after the procedure. In the study group that will be made to smell the mother's scent; The mother of each baby whose heel blood will be taken will be given a specially made cover made of 100% cotton yarn, sterilized the day before, and the mother will be asked to put the cover on her bare skin (on her bare skin) after the shower and to keep the cover on the mother's chest for one night (8 hours). It will be placed 15 cm away from the baby and smelled 5 minutes before and 5 minutes after the heel prick attempt. The baby's pain score will be evaluated by the observing nurse according to the NIPS pain scale 5 minutes before, during and 5 minutes after the procedure.

Conditions

Newborn; Vitality; Pain; Crying

Keywords

Crying Time; pain; newborn

Outcome Measures

Primary Outcomes (1)

• Neonatal Infant Pain Scale

  The Neonatal Infant Pain Scale was developed at Children's Hospital of Eastern Ontario. The Scale assesses six behavioral indicators in response to painful procedures in preterm newborns.The total score varies between 0 and 7 points, and a higher score indicates more pain

  1 day

Secondary Outcomes (1)

• criying time

  1 day

Study Arms (3)

Mother's Smell

EXPERIMENTAL

In the study group that will be made to smell the mother's scent; The mother of each baby whose heel blood will be taken will be given a specially made cover made of 100% cotton yarn, sterilized the day before, and the mother will be asked to put the cover on her bare skin (on her bare skin) after the shower and to keep the cover on the mother's chest for one night (8 hours). one). It will be placed 15 cm away from the baby and smelled 5 minutes before and 5 minutes after the heel prick attempt (1,4). The baby's pain score will be evaluated by the observing nurse according to the NIPS pain scale 5 minutes before, during and 5 minutes after the procedure.

Other: Mother's Smell

Mother's Breast Milk Smell

EXPERIMENTAL

In the study group that will be made to smell the scent of breast milk, the procedures for the scent of the mother will be carried out in the same way, and 20 drops of each baby's own mother's milk will be dropped onto the diaper (4). The cover, which has the scent of breast milk, will be placed 15 cm away from the baby and allowed to smell it from 5 minutes before to 5 minutes after the heel prick blood collection attempt. The baby's pain score will be evaluated by the observing nurse according to the NIPS pain scale 5 minutes before, during and 5 minutes after the procedure.

Other: Mother's Breast Milk Smell

Control

NO INTERVENTION

Routine care will be provided to the control group and no intervention will be applied.

Interventions

Mother's Smell OTHER

The mother of each baby whose heel blood will be taken will be given a specially made cover made of 100% cotton yarn, sterilized the day before, and the mother will be asked to put the cover on her bare skin (on her bare skin) after the shower and to keep the cover on the mother's chest for one night (8 hours). one).

Mother's Smell

Mother's Breast Milk Smell OTHER

In the study group that will be made to smell the scent of breast milk, the procedures for the scent of the mother will be carried out in the same way, and 20 drops of each baby's own mother's milk will be dropped onto the diaper.

Mother's Breast Milk Smell

Eligibility Criteria

• Age: 1 Day - 15 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Term newborns receiving treatment in Mersin City Training and Research Hospital Neonatal Intensive Care Service,
• Postnatal 1-15. Newborns on their day,
• Newborns who have not previously used any pharmacological or non-pharmacological method for pain management,
• Newborns with an Apgar score of 8 points or more at the 1st and 5th minutes,
• Not having undergone a surgical procedure,
• Does not have any health problems,
• Patients whose families approve the informed consent form.

You may not qualify if:

• Born before 37 weeks of gestation, receiving treatment in the Neonatal Intensive Care Service at Mersin City Training and Research Hospital,
• Sedation area
• Except for major congenital anomaly
• Older than the 15th postnatal day,
• Having a major anomaly or disease detected antenatally,
• Patients with comorbid diseases such as perinatal asphyxia, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, congenital heart disease and similar diseases,
• Patients whose families do not give consent will not be included in the study.

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus State Hospital

Mersin, Turkey (Türkiye)

Location

Related Publications (9)

• 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

• Gellrich J, Breuer AS, Han P, Guducu C, Hummel T, Schriever VA. Central Nervous System Processing of Floral Odor and Mother's Milk Odor in Infants. Chem Senses. 2021 Jan 1;46:bjab024. doi: 10.1093/chemse/bjab024.

  PMID: 34003211 BACKGROUND

• 3. Yigit, S., Ecevit, A., & Koroglu, O. A. (2018). Guidelines for pain and treatment in the newborn period. Turkish Neonatology Association, 53, 161-171.

  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

• 5. Çöçelli, L. P., Bacaksız, B. D., & Ovayolu, N. (2008). The nurse factor in pain therapy. European Journal of Therapeutics, 14(2), 53-58.

  BACKGROUND

• Lan HY, Yang L, Lin CH, Hsieh KH, Chang YC, Yin T. Breastmilk as a Multisensory Intervention for Relieving Pain during Newborn Screening Procedures: A Randomized Control Trial. Int J Environ Res Public Health. 2021 Dec 10;18(24):13023. doi: 10.3390/ijerph182413023.

  PMID: 34948633 BACKGROUND

• Beker F, Opie G, Noble E, Jiang Y, Bloomfield FH. Smell and Taste to Improve Nutrition in Very Preterm Infants: A Randomized Controlled Pilot Trial. Neonatology. 2017;111(3):260-266. doi: 10.1159/000450883. Epub 2016 Dec 1.

  PMID: 27902988 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

• 9. Akcan E. Yenidoğanlarda Topuk Kanı Alma Sırasında Oluşan Ağrıya Amniyotik Sıvı, Anne Sütü Ve Lavanta Kokusunun Etkisi (tez). Kayseri: Erciyes Üniversitesi; 2014.

  BACKGROUND

MeSH Terms

Conditions

Pain; Crying

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nonverbal Communication; Communication; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof.

Model Details: randomized controlled

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: March 14, 2024
• Primary Completion: September 23, 2024
• Study Completion: March 24, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)