About this trial
Aim: The aim of this study is to investigate the effects of massage administered for varying durations on comfort levels and physiological stability in late-preterm newborns receiving nCPAP. Method: The study will be conducted between Agust 2026 and June 2027 at the Neonatal Intensive Care Unit of Tarsus State Hospital with late preterm infants who will receive nCPAP therapy. Late preterm infants scheduled to receive nCPAP therapy (a total of 90 infants) will be divided into three groups (intervention group 1: 30; intervention group 2: 30; control group: 30). The pre-procedure comfort levels of all newborns will be assessed using the COMFORTneo Scale. In addition, the infants' heart rate, respiratory rate, oxygen saturation, and body temperature will be recorded. In addition to standard clinical procedures, newborns in the first intervention group will receive massage for 5 minutes twice daily for 3 days, in addition to routine clinical care. Newborns in the second intervention group will receive massage for 10 minutes twice daily for 3 days, in addition to routine clinical care. Newborns in the control group will not receive any additional intervention; only the clinic's routine care protocols will be followed.
After each massage session is completed, the newborns' comfort levels will be reassessed using the COMFORTneo Scale; heart rate, respiratory rate, oxygen saturation, and body temperature will be recorded. This procedure will be repeated for each session throughout the 3-day intervention period, and all measurements will be recorded on the follow-up form.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Be between 34⁰/₇ and 36⁶/₇ weeks of gestation,
Be receiving nCPAP support,
Be hemodynamically stable,
Have started enteral feeding,
Disqualifiers
Are receiving invasive mechanical ventilation,
Have undergone a surgical procedure,
Have a neurological disorder or a serious congenital anomaly,
Are receiving sedatives or neuromuscular blocking agents,
Trial design
Crossover
Treatments tested in this trial
1. İntervention group
Other interventionIn addition to routine clinical care, newborns in this group will receive a 5-minute massage twice a day for 3 days. The massage will be performed in accordance with the "Massage Administration Protocol.
2. İntervention group
Other interventionIn addition to routine clinical care, the newborns in this group will receive a 10-minute massage twice daily for 3 days. The massage will be performed in accordance with the "Massage Administration Protocol.
Treatment groups
Trial outcomes
Primary outcomes
NEWBORN INFORMATIONAL FORM
The form, prepared by the researcher in accordance with the literature, will consist of questions regarding the newborn's gestational age, birth weight, sex, mode of delivery, Apgar score, nCPAP usage status, and clinical characteristics (Karnati, 2020; Kahraman et al., 2020). The form is planned to include questions designed to assess the newborn's sociodemographic and clinical characteristics.
COMFORTNEO SCALE
The COMFORTneo Scale was developed by Van Dijk et al. (2009) to assess pain, stress, and comfort levels in preterm infants. The scale consists of a total of six parameters: level of alertness, calmness/agitation, respiratory response, crying, body movements, and facial tension. Each item is scored on a scale of 1 to 5, and the total possible score ranges from 6 to 30. A higher score on the scale indicates increased stress and distress in the newborn, while lower scores indicate a higher level of comfort.
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