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

NCT07773896 | Not Yet Recruiting

• 1 other identifier: 2026/09
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal; Preterm

Keywords

nCPAP; massage

Outcome Measures

Primary Outcomes (2)

• 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.

  1 day

• 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.

  Day 1, Day 2, Day 3

Study Arms (3)

5-minute massage session group

EXPERIMENTAL

In 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."

Other: 1. İntervention group

10-minute massage session group

EXPERIMENTAL

In addition to routine clinical care, newborns in this group will receive a 10-minute massage twice a day for 3 days. The massage will be performed in accordance with the "Massage Administration Protocol.

Other: 2. İntervention group

Control Group

NO INTERVENTION

No additional interventions will be administered to the newborns in this group; only the clinic's routine care protocols will be followed.

Interventions

1. İntervention group OTHER

In 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.

5-minute massage session group

2. İntervention group OTHER

In 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.

10-minute massage session group

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus University

Mersin, 33400, Turkey (Türkiye)

Location

Related Publications (11)

• https://doi.org/10.3389/fpsyg.2019.02298 McCarty, D. B., Zukowsky, K., & Hockenberry, M. (2023). Developmental care interventions in neonatal intensive care units. Journal of Pediatric Nursing, 69, 45-52.

  BACKGROUND

• Hillman NH, Kallapur SG, Jobe AH. Physiology of transition from intrauterine to extrauterine life. Clin Perinatol. 2012 Dec;39(4):769-83. doi: 10.1016/j.clp.2012.09.009.

  PMID: 23164177 BACKGROUND

• Guimarães, H., Rocha, G., & Pissarra, S. (2019). Nasal CPAP complications in preterm infants. Journal of Neonatal Nursing, 25(3), 125-131.

  BACKGROUND

• Field T. Pediatric Massage Therapy Research: A Narrative Review. Children (Basel). 2019 Jun 6;6(6):78. doi: 10.3390/children6060078.

  PMID: 31174382 BACKGROUND

• De Paoli AG, Davis PG, Faber B, Morley CJ. Devices and pressure sources for administration of nasal continuous positive airway pressure (NCPAP) in preterm neonates. Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD002977. doi: 10.1002/14651858.CD002977.pub2.

  PMID: 18254011 BACKGROUND

• Coughlin M, Gibbins S, Hoath S. Core measures for developmentally supportive care in neonatal intensive care units: theory, precedence and practice. J Adv Nurs. 2009 Oct;65(10):2239-48. doi: 10.1111/j.1365-2648.2009.05052.x.

  PMID: 19686402 BACKGROUND

• Cheong, J. L. Y., Spittle, A. J., Burnett, A. C., Anderson, P. J., & Doyle, L. W. (2020). Preterm birth and neurodevelopmental outcomes. Clinics in Perinatology, 47(1), 1-14.

  BACKGROUND

• Behnke, J., Lemyre, B., & Laughon, M. (2019). Non-invasive respiratory support in neonates. Current Opinion in Pediatrics, 31(2), 220-226.

  BACKGROUND

• Acolet D, Modi N, Giannakoulopoulos X, Bond C, Weg W, Clow A, Glover V. Changes in plasma cortisol and catecholamine concentrations in response to massage in preterm infants. Arch Dis Child. 1993 Jan;68(1 Spec No):29-31. doi: 10.1136/adc.68.1_spec_no.29.

  PMID: 8439193 BACKGROUND

• Asadollahi, M., Eskandari, N., & Hasanpour, M. (2016). Effects of developmental care on preterm infant outcomes: A review study. International Journal of Pediatrics, 4(10), 3711-3720.

  BACKGROUND

• Arham M, Wroblewska-Seniuk K. Short- and Long-Term Consequences of Late-Preterm and Early-Term Birth. Children (Basel). 2025 Jul 9;12(7):907. doi: 10.3390/children12070907.

  PMID: 40723099 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Duygu SÖNMEZ DÜZKAYA, PhD

CONTACT

++903246000033; duygusduzkaya@tarsus.edu.tr

Fadime Kısa, BsC

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 19, 2026
• Study Start: September 25, 2026
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Locations

TU (1)