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This study will be conducted to determine the effect on pain and vital signs of multiple nonpharmacological methods used in preterm infants during the examination for retinopathy of prematurity (ROP).
Retinopathy of prematurity (ROP) examination is performed using a binocular indirect ophthalmoscope. ROP examination causes pain and discomfort in the preterm infant in many ways, including the application of eye drops, the placement of the speculum in the eye, the pressure applied to the pupils and the brightness of the ophthalmoscope. Studies in the literature have also reported that newborns experience pain and discomfort during ROP examination. In relation to the ROP pain experienced by the preterm infant, various physiological changes such as increased heart rate or decreased oxygen saturation are experienced during or after the examination. Accordingly, ROP examination is important; however, controlling the pain that occurs during the examination is also very important in terms of the patient's emotional experience and comfort. In the literature, many studies have been conducted to reduce pain during ROP examination. Although pharmacological treatment methods are an effective technique to reduce pain, it is recommended that nonpharmacological methods should be used especially in infants and children because of the side effects of drugs (such as apnoea, bradycardia, respiratory depression, hypotension) and the method to be used should be easy, fast and does not require preparation. The Turkish Neonatology Society and the Turkish Ophthalmology Society also recommend that ROP examination is a very painful procedure, that pharmacological methods alone are not sufficient to reduce pain, and that nonpharmacological methods such as pacifier, breast milk and oral sucrose should be used during the examination. In addition, although there is no gold standard for pain relief during ROP examination, previous studies suggest that clinicians should use more than one method together to reduce pain and provide relief in premature infants. In this study, a combination of oral 25% dextrose, non-nutritive sucking and swaddling will be used for multiple nonpharmacological applications
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Sham Comparator | Retinopathy of prematurity examination will be performed according to clinical routine practice. |
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| Intervention Group | Active Comparator | Multiple nonpharmacological methods will be applied for pain management during retinopathy of prematurity examination. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple nonpharmacological methods | Procedure | The preterm babies in this group are swaddled by the nurse with each baby's own blanket 2 minutes before the ROP examination. The nurse will then give the baby 25% dextrose solution orally (0.5ml for those <32 weeks gestation, 1ml for those >32 weeks gestation). The nurse then places a pacifier soaked in 25% dextrose solution in the preterm infant's mouth. After these three non-pharmacological methods, the doctor will perform the ROP examination. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural pain score: Premature Infant Pain Profile-Revised Scale (PIPP-R) | The PIPP-R is a seven indicator composite pain measure consisting of three behavioural (facials actions of brow bulge, eye squeeze, naso-labial furrow), two physiological (heart rate, oxygen saturation), and two contextual (gestational age, behavioural state) indicators validated for pain measurement in infants 26-44 weeks' gestation. A score of <7 is indicative of minimal pain and a score ≥ 12 is indicative of moderate to severe pain. | 1 minute before the procedure, during the procedure, 2 minutes after the procedure and 5 minutes after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen saturation | Premature infants will be connected to a pulse oximeter monitor; oxygen saturation will be monitored before, during and after the procedure. | 1 minute before the procedure, during the procedure, 2 minutes after the procedure and 5 minutes after the procedure |
| Heart rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aynur Aytekin Ozdemir, Professor | İstanbul Medeniyet University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medeniyet University | Istanbul | Istanbul | 34862 | Turkey (Türkiye) |
Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
July through December of 2026
Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
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| Routine Treatment | Other | The preterm babies in this group are swaddled by the nurse with each baby's own blanket 2 minutes before the ROP examination. After these three non-pharmacological methods, the doctor will perform the ROP examination. |
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Premature infants will be connected to a pulse oximeter monitor; heart rate will be monitored before, during and after the procedure. |
| 1 minute before the procedure, iduring the procedure, 2 minutes after the procedure and 5 minutes after the procedure |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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