- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07917871
Effects of Environmental Comfort and Oral Motor Stimulation on Comfort and Oral Feeding Readiness in Preterm Infants
Effects of Environmental Comfort and Oral Motor Stimulation Interventions on Comfort and Oral Feeding Readiness in Preterm Infants: An Experimental Study
This study aims to evaluate the effects of short-term environmental comfort interventions and oral motor stimulation on comfort and oral feeding readiness in preterm infants. A total of 84 preterm infants who are clinically stable and transitioning to oral feeding will be assigned to one of four groups: massage, white noise, oral stimulation, or routine care (control). Before the intervention, infant comfort and oral feeding readiness will be assessed using the Premature Infant Comfort Scale and the Preterm Oral Feeding Readiness Assessment Scale (POFRAS). Infants in the intervention groups will receive a single 5-minute session of massage, white noise, or oral stimulation before their first oral feeding, while infants in the control group will receive routine care. Comfort and oral feeding readiness will be assessed during the study to compare the effects of the interventions. The study will also examine the relationship between comfort and oral feeding readiness in preterm infants.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
This experimental study will be conducted with preterm infants receiving care in the Neonatal Intensive Care Unit of Cerrahpaşa Faculty of Medicine Hospital. The study will include 84 preterm infants born between 28 and 37 weeks of gestation who are clinically stable and in the process of transitioning to oral feeding. Eligible infants will be randomly assigned to one of four study groups: massage, white noise, oral stimulation, or routine care (control). Before the assigned intervention, descriptive and clinical information will be recorded, and the infants will be assessed using the Premature Infant Comfort Scale and the Preterm Oral Feeding Readiness Assessment Scale (POFRAS). In the massage group, infants will receive a 5-minute session consisting of gentle and rhythmic tactile stimulation. In the white noise group, white noise at an intensity of 40-60 dB will be provided for 5 minutes. In the oral stimulation group, infants will receive a 5-minute oral motor stimulation intervention involving gentle stimulation of the lips, cheeks, palate, gums, and tongue, with non-nutritive sucking when appropriate. Infants assigned to the control group will receive routine neonatal care without an additional study intervention. The assigned intervention will be administered once before the infant's first oral feeding. Following the intervention period, the infant's comfort and oral feeding readiness will be evaluated according to the study assessment schedule, and the first oral feeding will be performed when oral feeding has been clinically authorized by the physician. The study will compare comfort and oral feeding readiness among the intervention and control groups and will examine the relationship between comfort and oral feeding readiness in preterm infants.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Aysegul Simsek, PhD
- Telefonszám: +905413155774
- E-mail: asimsek@marmara.edu.tr
Tanulmányi helyek
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Istanbul, Törökország (Türkiye)
- Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine Hospital
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Kapcsolatba lépni:
- Dilara Karaköse, CN
- Telefonszám: +90 507 879 87 57
- E-mail: dilara.karakose1@iuc.edu.tr
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Preterm infants born between 28 and 37 weeks of gestation
- Clinically stable preterm infants
- Infants for whom the physician has decided to initiate oral feeding
- Infants transitioning to oral feeding
- Written informed consent provided by a parent or legal guardian
Exclusion Criteria:
- Congenital anomalies or neurological disorders that may affect oral feeding
- Severe respiratory or cardiac problems that may prevent oral feeding
- Clinical instability that prevents participation in the study interventions or oral feeding
- Withdrawal of parental or legal guardian consent
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: Massage
Infants assigned to this group will receive a single 5-minute massage intervention before their first oral feeding. The intervention will include gentle, rhythmic tactile stimulation of the back and shoulders, followed by gentle stroking and touch. |
A single 5-minute massage session will be administered before the infant's first oral feeding. The intervention will include gentle rhythmic stroking of the back and shoulders, gentle downward stroking of the back, slow rhythmic touch to the shoulder or head area, and gentle hand contact over the abdominal area. |
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Kísérleti: White Noise
Infants assigned to this group will be exposed to white noise at an intensity of 40-60 dB for 5 minutes before their first oral feeding. No additional care or procedure will be performed during the white noise intervention. |
White noise at an intensity of 40-60 dB will be provided for 5 minutes before the infant's first oral feeding. The sound source will be positioned approximately 30-50 cm from the infant's bed. No additional care or procedure will be performed during the intervention. |
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Kísérleti: Oral Stimulation
Infants assigned to this group will receive a single 5-minute oral motor stimulation intervention before their first oral feeding. The intervention will include gentle stimulation of the lips, inner cheeks, palate, gums, and tongue, with non-nutritive sucking when appropriate. |
A single 5-minute oral motor stimulation session will be administered before the infant's first oral feeding. The intervention will include gentle stimulation of the lips, inner cheeks, palate, gums, and tongue. Non-nutritive sucking using a sterile finger or pacifier may be provided when appropriate. |
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Aktív összehasonlító: Routine Care
Infants assigned to the control group will receive routine neonatal care without an additional study intervention before their first oral feeding. |
Infants assigned to the control group will receive routine neonatal care without additional massage, white noise, or oral motor stimulation as part of the study intervention. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in Premature Infant Comfort Scale Score
Időkeret: Within 1 minute before the start of the intervention, within 1 minute after the completion of the 5-minute intervention (before the first oral feeding), and within 1 minute after the completion of the first oral feeding.
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Developed by Monique and her colleagues, this is an observation-based scale used to assess the comfort level of premature infants. The scale was adapted into Turkish by Dilek Küçük Alemdar and Fatma Güdücü Tüfekçi (2015) in Turkey, and a validity and reliability study was conducted. The scale consists of a total of 7 items: level of alertness, agitation, crying, physical movement, muscle tone, facial expressions, and heart rate. Each item is rated on a scale of 1 to 5, and the total score ranges from 7 to 35. There are no reverse-scored items on the scale. Factor analysis conducted as part of the construct validity assessment determined that the scale exhibits a unifactorial structure, explaining 57.7% of the total variance. The scale's Cronbach's alpha reliability coefficient was reported as 0.88. |
Within 1 minute before the start of the intervention, within 1 minute after the completion of the 5-minute intervention (before the first oral feeding), and within 1 minute after the completion of the first oral feeding.
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Change in Preterm Oral Feeding Readiness Assessment Scale Score
Időkeret: Within 1 minute before the start of the intervention (initial assessment) and within 1 minute after the completion of the 5-minute intervention (before the start of the first oral feeding).
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Developed by Cristina Ide Fujinaga and colleagues (2007) to assess how ready preterm infants are for the transition to oral feeding, the scale underwent a clinical validity study in 2013. The Turkish validity and reliability study of the scale was conducted by Çamur and Çetinkaya (2021). The scale consists of a total of 18 items, each of which is scored on a scale of 0, 1, or 2. The total possible score ranges from 0 to 36. There are no reverse-scored items on the scale. The scale covers areas such as behavioral status, oral-motor posture, reflexes, and sucking behavior; while its subdimensions are not explicitly named, they are clinically grouped under five headings: corrected gestational age, behavioral organization, oral posture, reflex assessment, and non-nutritive sucking. In the Turkish adaptation, the optimal cutoff score for the scale was reported as 29, and the Cronbach's alpha internal consistency coefficient was found to be 0.87. |
Within 1 minute before the start of the intervention (initial assessment) and within 1 minute after the completion of the 5-minute intervention (before the start of the first oral feeding).
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Time to Initiate Post-intervention Oral Feeding
Időkeret: The time elapsed (in minutes) from the completion of the five-minute intervention until the start of the first oral feeding up to 20 minutes
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The time to initiation of the first oral feeding in preterm infants will be defined as the duration from the completion of the 5-minute intervention until the start of the first oral feeding. This duration will be recorded in minutes and compared across groups. The first oral feeding will be administered to infants determined by a physician to be ready for oral feeding. |
The time elapsed (in minutes) from the completion of the five-minute intervention until the start of the first oral feeding up to 20 minutes
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Aysegul Simsek, PhD, Marmara University
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Urogenitális betegségek
- Női urogenitális betegségek és terhességi szövődmények
- Szülészeti munka, koraszülött
- Szülészeti szövődmények
- Terhességi szövődmények
- Viselkedés
- Viselkedés, állat
- Koraszülés
- Táplálkozási viselkedés
- Terápiás kezelés
- Kiegészítő terápiák
- Fizikoterápiás módszerek
- Rehabilitáció
- Terápia, lágyszöveti
- Izom -csontrendszeri manipulációk
- Masszázs
Egyéb vizsgálati azonosító számok
- MU-SBF-2025-173
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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