Ege Unversity
Bornova, İzmir, 35100, Turkey (Türkiye)
NCT Number: NCT07127679
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
Looking for future studies?
Notify Me30 week–34 week
All sexes
Interventional
Not applicable
Bornova, İzmir, 35100, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: one week
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.
Time frame: one week
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.
Ege University
Other
The Effect of Breast Milk on Pain and Stress During Retinopathy of Prematurity Examination
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03481166
Behavior, Breast Feeding
London, Ontario, Canada
View Trial DetailsNCT01074190
Behavior, Breast Feeding
Chicago, Illinois, United States
View Trial DetailsNCT02133716
Behavior, Breast Feeding
Madrid, Spain
View Trial DetailsNCT06824337
Behavior, Breast Feeding
Niğde, Turkey (Türkiye)
View Trial Details