The Effect of Breast Milk on Pain and Stress

NCT07127679 | Completed DMC

• 1 other identifier: 1462/1442
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Breastfeeding; Retinopaty of Prematurity; Pain; Stress

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Premature Infant Pain Profile (PIPP),

  The Premature Infant Pain Profile (PIPP) is a behavioral measure of pain for premature infants. It was developed at the Universities of Toronto and McGill in Canada. Minimum score: 0, maximum score: 21.The higher the score the greater the pain behavior.The PIPP is a 7-item multidimensional (composite) measure of pain that has been used widely to assess acute pain in infants. The PIPP includes 3 behavioral (facial actions: brow bulge, eye squeeze, nasolabial furrow), 2 physiological (heart rate and oxygen saturation), and 2 contextual (gestational age \[GA\] and behavioral state \[BS\]) items.

  one week

• Neonatal Stress Scale

  This scale is used in premature babies. It was prepared to evaluate stress. 8 subgroups (facial expression, body color, breathing, activity level, consolability, muscle tone, extremities, posture). The form consisting of 24 items is a 3-point Likert type. In the preparation of the draft form, the principles included in the Synactive Theory created within the framework of concepts. Each subgroup is scored between 0 and 2. The maximum score on the scale is 16, and the minimum is 0. A score of 0 indicates that the baby is not stressed. The higher the score, the higher the baby's stress level.

  one week

Study Arms (2)

breast milk group

EXPERIMENTAL

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.

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

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.

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 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.

breast milk group

Eligibility Criteria

• Age: 30 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege Unversity

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding; Pain; Retinopathy of Prematurity

Interventions

Pregnane X Receptor

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Receptors, Steroid; Receptors, Cytoplasmic and Nuclear; Proteins; Amino Acids, Peptides, and Proteins; Transcription Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical nursing

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 17, 2025
• Study Start: February 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

TU (1)