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

NCT07773896 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-08-19

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Tarsus University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
1 Day
Max Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-25
Primary Completion
2027-03-10
Completion
2027-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07773896 on ClinicalTrials.gov