The Effect of Breast Milk on Pain and Stress

NCT ID: NCT07127679

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-03-01

Brief Summary

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

Detailed 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.

Conditions

Breastfeeding; Retinopaty of Prematurity; Pain; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

breast milk group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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, 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. 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.

control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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, 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. 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Weeks
• Maximum Eligible Age: 34 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Emel BULDUR

clinical nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ege Unversity

Bornova, İzmir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

1462/1442

Identifier Type: -

Identifier Source: org_study_id