The Effect of Newborn Massage on Comfort Level and Vital Signs

NCT06529263 | Completed

• 1 other identifier: E-10840098-772.02-7436
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Newborn

Keywords

Newborn; infant massage; vital signs; comfort

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (2)

Massage group

EXPERIMENTAL

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

Control group

NO INTERVENTION

is the group without intervention

Interventions

newborn massage OTHER

Newborn massage is one of the complementary treatment methods that support the treatment and contribute to the development of the baby

Massage group

Eligibility Criteria

• Age: 1 Day - 7 Days
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

Study Officials

• Aysel Kokcu Dogan

  Faculty Member

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., Asst. Prof.

Model Details: Randomized controlled experimental study

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 31, 2024
• Study Start: January 3, 2023
• Primary Completion: December 25, 2023
• Study Completion: September 15, 2024
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)