The Effect of Infant Massage Applied at Different Durations on Comfort and Physiological Stability in Late Preterm Infants Receiving nCPAP

The study is planned to be conducted between August and June at the Neonatal Intensive Care Unit (NICU) of Tarsus State Hospital. The NICU at Tarsus State Hospital is a tertiary-care center that provides advanced neonatal care services and monitors premature and high-risk newborns. The care and treatment of preterm newborns receiving noninvasive mechanical ventilation support in the unit are provided through a multidisciplinary team approach. Since the unit where the study will be conducted monitors late-preterm newborns receiving nCPAP support, it provides a suitable clinical environment for the study.

Variables:

Dependent variables: Comfort level (COMFORTneo Scale score), Heart rate (HR), Respiratory rate, Oxygen saturation (SpO₂), Body temperature Independent variables: Massage duration (5 minutes / 10 minutes / control), Frequency of application (twice daily for 3 days) Control variables: Gestational age (34⁰/₇-36⁶/₇), Birth weight, Sex, Nutritional status Study Implementation and Data Collection The necessary ethical committee and institutional approvals will be obtained before the study begins. The necessary plans regarding the study process will be made at the Neonatal Intensive Care Unit of Tarsus State Hospital, where the study will be conducted; team coordination, the implementation schedule, and the data collection process will be determined in advance. The implementation steps of the study are listed below.

Pilot Study: A pilot study will be conducted prior to the main study to assess the feasibility of the data collection forms and the appropriateness of the research process. Newborns included in the pilot study will not be included in the research sample.

Consent Process: The parents of late-preterm newborns who meet the inclusion criteria for the study will be informed about the purpose of the study, the implementation process, the data collection stages, and potential situations that may arise during the massage intervention (such as desaturation, bradycardia, or tachycardia; in the event that signs of physiological instability are observed, the intervention will be immediately discontinued and the necessary clinical intervention will be provided). Written informed consent will be obtained from parents who agree to participate in the study. It will be clearly stated that parents may withdraw their consent to participate in the study at any time without providing a reason and without affecting their infant's care.

Recording of Demographic Information: The sociodemographic and clinical characteristics of the newborns included in the study-including gestational age, birth weight, sex, mode of delivery, Apgar score, nCPAP usage status, and clinical characteristics-will be recorded by the researcher using the Newborn Demographic Information Form. Pre-Test Measurements: The pre-procedure comfort levels of all newborns included in the study will be assessed using the COMFORTneo Scale by a trained nurse-who is different from the researcher administering the massage-in order to minimize observer bias. The same nurse will read the newborns' heart rate, respiratory rate, oxygen saturation, and body temperature from the monitor and record them on the Pre- and Post-Intervention Physiological Parameters and Comfort Monitoring Form.

Randomization: Newborns who have completed the baseline measurements will be randomly assigned in equal numbers to three groups-the first intervention group, the second intervention group, and the control group-using a computer-generated randomization list. It is planned to include 30 newborns in each group, with a total of 90 newborns targeted for inclusion in the study.

Group Interventions: Newborns in the intervention groups will receive massage based on the tactile/kinesthetic stimulation approach developed by Field et al. (1986). The massage sessions will be conducted by the researcher.

The massage sessions were scheduled in accordance with the standard feeding schedule of the neonatal intensive care unit; massages are planned to be performed twice daily-at 10:00 a.m. and 4:00 p.m.-at least one hour after feeding. Prior to each session, the newborn's hemodynamic stability will be assessed; during the session, heart rate, respiratory rate, and oxygen saturation levels will be monitored (dos Anjos et al., 2021). If desaturation, bradycardia, tachycardia, or signs of clinical instability are observed during the session, the massage will be stopped immediately and the clinical team will be notified.

• First intervention group: In addition to routine clinical care, newborns in this group will receive a 5-minute massage twice daily for 3 days. The massage will be performed in accordance with the "Massage Administration Protocol."
• Second intervention group: In addition to routine clinical care, 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."
• Control group: No additional interventions will be administered to the newborns in this group; only the clinic's routine care protocols will be followed. - Routine clinical care includes: maintaining nCPAP support; carrying out treatment and monitoring procedures in accordance with physicians' orders; administering enteral nutrition; ensuring proper positioning; providing oral and skin care; monitoring vital signs; implementing infection control measures; and providing developmental care.

Recording Final Measurements: After the completion of each massage session, the same nurse who performed the initial measurements will reassess the newborns' comfort levels using the COMFORTneo Scale (Appendix 2); heart rate, respiratory rate, oxygen saturation, and body temperature values 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 provided in Appendix 3.

Massage Protocol The massage will be performed in accordance with the Field massage technique, which is widely used in the literature for preterm newborns (Field et al., 1986; Diego and Field, 2009). During the session, the newborn's tolerance level will be taken into account, and the massage will be adjusted based on the newborn's behavioral cues.

Natural cold-pressed olive oil will be used during the massage to lubricate the skin and reduce friction-related skin irritation (Bal Yılmaz, 2019; Jabraeile et al., 2016). Oil will not be applied to the face. The sessions will be conducted in an environment where the incubator temperature is maintained at 32-34°C to preserve the newborn's thermal stability. Rhythmic, moderate-pressure tactile stimulation will be applied to the face, chest, upper extremities, lower extremities, and back of the newborns in both supine and prone positions, in accordance with the tactile/kinesthetic stimulation approach developed by Field and colleagues.

The massage will utilize effleurage, petrissage, and friction techniques involving light pressure. Throughout the procedure, the newborns' heart rate, respiratory rate, and oxygen saturation levels will be monitored. If desaturation, bradycardia, tachycardia, or signs of physiological stress are observed during the procedure, the session will be terminated (Field, 2014; dos Anjos et al., 2021).

Routine clinical care: Routine clinical care includes the continuation of nCPAP support; the implementation of treatment and monitoring procedures in accordance with physicians' orders; nutritional care; repositioning; oral and skin care; monitoring of vital signs; infection control measures; and developmental care. No massage therapy will be provided to the control group as part of this study.

Inclusion criteria

• Newborns must:
• Be between 34⁰/₇ and 36⁶/₇ weeks of gestation,
• Be receiving nCPAP support,
• Be hemodynamically stable,
• Have started enteral feeding,
• Have no congenital anomalies,
• Their parents must voluntarily agree to participate in the study and provide written informed consent.

Exclusion criteria

• Newborns who:
• 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,
• Whose clinical condition is not suitable for massage,
• Who have a dermatological condition that could compromise skin integrity or a skin lesion that could interfere with massage,
• Who have medical device-related pressure injuries caused by nCPAP.