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Completed

NCT Number: NCT06529263

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.

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Key information

Conditions

Newborn

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

newborn massage

Other

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

Primary outcomes

  1. Body temperature

    Time frame: Measurements were taken before and after the newborn massage 2 times a day for 4 days.

    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).

  2. Pulse

    Time frame: Measurements were taken before and after the newborn massage 2 times a day for 4 days.

    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).

  3. Respiration

    Time frame: Measurements were taken before and after the newborn massage 2 times a day for 4 days.

    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).

  4. Understanding Pulse Oximetry

    Time frame: Measurements were taken before and after the newborn massage 2 times a day for 4 days.

    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).

  5. Newborn comfort behaviors scale

    Time frame: Measurements were taken before and after the newborn massage 2 times a day for 4 days.

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 31, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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