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

August 15, 2026 updated by: Duygu Sonmez Duzkaya, Tarsus University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fadime Kısa, BsC

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5-minute massage session group
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
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.
Experimental: 10-minute massage session group
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
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.
No Intervention: Control Group
No additional interventions will be administered to the newborns in this group; only the clinic's routine care protocols will be followed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NEWBORN INFORMATIONAL FORM
Time Frame: 1 day
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
Time Frame: Day 1, Day 2, Day 3
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tarsus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 25, 2026

Primary Completion (Estimated)

March 10, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

August 6, 2026

First Submitted That Met QC Criteria

August 15, 2026

First Posted (Actual)

August 19, 2026

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 15, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026/09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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