The Effect of Breast Milk on Pain and Stress

Ege University

Status: Completed

Conditions: Breastfeeding; Retinopaty of Prematurity; Pain; Stress

Treatments: Other: Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As par

Study type: Interventional

Funder types: Other

Identifiers

NCT07127679

1462/1442

Details and patient eligibility

About

This study aimed to examine the effect of breast milk on pain and stress during Retinopathy of Prematurity (ROP) examinations. This randomized controlled experimental study was conducted with premature infants (N = 154) hospitalized in the Department of Child Health and Diseases, Neonatology Unit, at Izmir Ege University Faculty of Medicine Hospital between February 2024 and January 2025. A total of 36 premature infants (experimental group: 18; control group: 18) who met the inclusion criteria were included in the study. Data were collected using the Infant Information Form, the Premature Infant Pain Profile (PIPP), and the Neonatal Stress Scale. Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. Breast milk may be effective in reducing pain and stress associated with ROP examinations.

Keywords: Retinopathy of Prematurity; ROP; Breast Milk; Pain; Stress

Full description

This study aimed to examine the effect of breast milk on pain and stress during Retinopathy of Prematurity (ROP) examinations. This randomized controlled experimental study was conducted with premature infants (N = 154) hospitalized in the Department of Child Health and Diseases, Neonatology Unit, at Izmir Ege University Faculty of Medicine Hospital between February 2024 and January 2025. A total of 36 premature infants (experimental group: 18; control group: 18) who met the inclusion criteria were included in the study. Data were collected using the premature infant information form, the premature infant vital signs record form, the Premature Infant Pain Profile (PIPP), and the Neonatal Stress Scale. Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As part of routine care, all infants were swaddled and given a pacifier before the procedure. Video recording began 3 minutes prior to the ROP examination and continued until the infant stopped crying post-examination. Recordings were assessed by two independent observers to determine pain and stress scores, as well as parameters such as heart rate, oxygen saturation, perfusion index, and duration of crying.

The study found that pain scores were significantly lower in the group that received breast milk prior to the ROP examination compared to the control group (p <0.001). Stress scores were also significantly lower in the breast milk group (p < 0.001).The breast milk group showed more favorable oxygen saturation and heart rate levels (p < 0.05). There was no significant difference in perfusion index between the two groups. Crying duration was significantly shorter in the breast milk group compared to the control group (p < 0.001). Breast milk may be effective in reducing pain and stress associated with Retinopathy of Prematurity examinations.

Enrollment: 36 patients

Sex: All

Ages: 30 to 34 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The baby's birth week is ≤34 or birth weight is ≤1700 grams, room babies who are monitored in good mood and have good clinical findings
• Babies who have developed sucking and swallowing skills and can hold a pacifier
• Any analgesic, muscle relaxant and sedative that may affect the pain level not taking effective medication
• The family agrees to participate in the study.
• Babies are in neonatal intensive care
• Having babies who are exclusively breastfed
• First ROP examination

Exclusion criteria

• Babies with congenital anomalies and metabolic diseases, cleft palate and cleft babies with lips did not sign the informed consent form and did not participate in the study.
• Babies from families that did not accept were not included in the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

breast milk group

Experimental group

Description:

Two minutes before the ROP examination, 2mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As part of routine care, all infants were swaddled and given a pacifier before the procedure. Video recording began 3 minutes prior to the ROP examination and continued until the infant stopped crying post-examination.

Treatment:

Other: Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As par

control group

No Intervention group

Description:

As part of routine care, all infants were swaddled and given a pacifier before the procedure. Video recording began 3 minutes prior to the ROP examination and continued until the infant stopped crying post-examination.