The Effect of Newborn Massage on Comfort Level and Vital Signs

This study was planned as a randomized, controlled, experimental study to examine the effect of neonatal massage on the comfort level and vital signs of newborn babies.An answer to the question "Does massage applied to infants in the neonatal period have an effect on vital signs and comfort level?" will be sought.

Study Overview

• Status: Completed
• Conditions: Newborn
• Intervention / Treatment: Other: newborn massage

Detailed Description

The sample of the study consisted of a total of 60 infants, 30 in the experimental group and 30 in the control group, who were hospitalized in the Neonatal Intensive Care Unit of a City Hospital between December 2022 and April 2023, whose parents' written and verbal consent was obtained for participation in the study after being informed, and who met the inclusion criteria. "Data Collection Form", 'Life Findings Assessment Form' and 'Newborn Comfort Behaviors Scale' prepared by the researchers were used as data collection tools. Newborns in the experimental group were massaged twice a day for 15 minutes 30 minutes after feeding and routine care for 4 days. The data obtained in the study will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 program.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Beykoz
    • Istanbul, Beykoz, Turkey (Türkiye), 34810
      • Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Gestational age between 37-42 weeks,
• Birth weight of 2500 grams and above,
• The infant was hospitalized in the Neonatal Intensive Care Unit during data collection,
• Completion of 24 hours after birth

Exclusion Criteria:

• Gestational age below 37 weeks,
• Birth weight below 2500 grams,
• Refusal of the parent to participate in the study,
• The baby is on mechanical ventilation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Massage group; is the newborn massage group.The experimental group was massaged twice a day for 15 minutes 30 minutes after feeding and routine care for 4 days.	Other: newborn massage; Newborn massage is one of the complementary treatment methods that support the treatment and contribute to the development of the baby
No Intervention: Control group; is the group without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body temperature	Measurements were taken at 10.00 am in the morning. After 30 minutes, neonatal massage was performed. The newborn massage lasted 15 minutes. Measurements were taken again 30 minutes after the massage. Measurements were taken at 22.00 in the evening. Newborn massage lasted 15 minutes. Measurements were taken again 30 minutes after the massage was finished (Measurements were taken before and after the massage performed 2 times a day).	Measurements were taken before and after the newborn massage 2 times a day for 4 days.
Pulse	Measurements were taken at 10.00 am in the morning. After 30 minutes, neonatal massage was performed. The newborn massage lasted 15 minutes. Measurements were taken again 30 minutes after the massage. Measurements were taken at 22.00 in the evening. Newborn massage lasted 15 minutes. Measurements were taken again 30 minutes after the massage was finished (Measurements were taken before and after the massage performed 2 times a day).	Measurements were taken before and after the newborn massage 2 times a day for 4 days.
Respiration	Measurements were taken at 10.00 am in the morning. After 30 minutes, neonatal massage was performed. The newborn massage lasted 15 minutes. Measurements were taken again 30 minutes after the massage. Measurements were taken at 22.00 in the evening. Newborn massage lasted 15 minutes. Measurements were taken again 30 minutes after the massage was finished (Measurements were taken before and after the massage performed 2 times a day).	Measurements were taken before and after the newborn massage 2 times a day for 4 days.
Understanding Pulse Oximetry	Measurements were taken at 10.00 am in the morning. After 30 minutes, neonatal massage was performed. The newborn massage lasted 15 minutes. Measurements were taken again 30 minutes after the massage. Measurements were taken at 22.00 in the evening. Newborn massage lasted 15 minutes. Measurements were taken again 30 minutes after the massage was finished (Measurements were taken before and after the massage performed 2 times a day).	Measurements were taken before and after the newborn massage 2 times a day for 4 days.
Newborn comfort behaviors scale	Measurements were taken at 10.00 am in the morning. After 30 minutes, neonatal massage was performed. The newborn massage lasted 15 minutes. Measurements were taken again 30 minutes after the massage. Measurements were taken at 22.00 in the evening. Newborn massage lasted 15 minutes. Measurements were taken again 30 minutes after the massage was finished (Measurements were taken before and after the massage performed 2 times a day). The comfort levels of newborn babies before and after massage were checked. Evaluation was made using the neonatal comfort scale. The lowest score that can be obtained from the Neonatal Comfort Behavior Scale is 6 and the highest score is 30. If the total score of the scale is between 14-30, it is emphasized that the baby has pain or distress, the baby is uncomfortable and needs interventions to provide comfort.	Measurements were taken before and after the newborn massage 2 times a day for 4 days.

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Study Director: Aysel Kokcu Dogan, faculty member

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Actual): December 25, 2023
• Study Completion (Actual): September 15, 2024

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: comfort; Newborn; vital signs; infant massage
• Other Study ID Numbers: E-10840098-772.02-7436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No