CompletedNot Applicable

The Effect of Breast Milk on Pain and Stress

Turkey (Türkiye)36 participantsStarted 2024-02-01

Plain-language 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

Who can participate

Age range30 Weeks – 34 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Premature Infant Pain Profile (PIPP),

Timeframe: one week

Neonatal Stress Scale

Timeframe: one week

Trial details

NCT IDNCT07127679

SponsorEge University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-01