Trials / Completed

CompletedNCT07127679

The Effect of Breast Milk on Pain and Stress

The Effect of Breast Milk on Pain and Stress During Retinopathy of Prematurity Examination

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 36 (actual)

Sponsor: Ege University · Academic / Other
Sex: All
Age: 30 Weeks – 34 Weeks
Healthy volunteers: Not accepted

Summary

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

Interventions

Type	Name	Description
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	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.

Timeline

Start date: 2024-02-01
Primary completion: 2025-01-01
Completion: 2025-03-01
First posted: 2025-08-17
Last updated: 2025-08-17

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07127679. Inclusion in this directory is not an endorsement.