Effects of Oil and Dry Neonatal Massage on Hyperbilirubinemia and Comfort

NCT06630689 | Completed

• 1 other identifier: IU-SBF-MG-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The need for infant massage may come to the forefront as a part of routine care in the neonatal intensive care unit to reduce high bilirubin levels in newborns and to reduce the need for phototherapy treatment. This study was planned to investigate the effects of oily and dry neonatal massage on hyperbilirubinemia and comfort.

Conditions

Hyperbilirubinemia, Neonatal

Keywords

hyperbilirubinemia; massage; comfort; newborn

Outcome Measures

Primary Outcomes (2)

• Newborn Comfort Behavior Scale (COMFORTneo)

  The Newborn Comfort Behavior Scale, developed to determine sedation, need for comfort, pain or distress in infants followed in the NICU, is a five-point Likert-type scale. The five-point Likert-type scale consists of six parameters including alertness, calmness/agitation, respiratory response, crying, body movements, facial tension and muscle tone. In infants receiving mechanical ventilation, the "Respiratory Response" element is taken into account, and in those not receiving mechanical ventilation, the "Crying" element is taken into account.

  9 months

• Numerical Assessment Scales

  Numerical Assessment Scales are based on the observation of the researcher. Each item in the scale is scored from 1 to 5 and evaluated over a total score. The lowest score on the scale should be 6 and the highest score should be 30. If the total score obtained from the scale is between 9-13, it means that the newborn is comfortable, and if it is between 14-30, it means that the newborn is in pain or distress and therefore not comfortable.

  9 months

Study Arms (3)

control group

NO INTERVENTION

Babies in the control group will receive treatment and care according to neonatal intensive care unit procedures. No intervention will be applied.

Dry Full Body Massage Group

EXPERIMENTAL

Unlike the control group, dry whole body massage was applied to the babies who were followed up after completing the phototherapy treatment process.

Other: Dry Full Body Massage

Oil Full Body Massage Group

EXPERIMENTAL

Unlike the control group, the babies in this group received a full body oil massage. The full body oil massage was applied using pure baby olive oil.

Other: Oil Full Body Massage

Interventions

Dry Full Body Massage OTHER

Applying massage after phototherapy

Dry Full Body Massage Group

Oil Full Body Massage OTHER

Oil Full Body Massage

Oil Full Body Massage Group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being a term (37-42 weeks) newborn.
• The newborn's postnatal age is between 1st and 28th days
• The 1st and 5th Apgar score is between 7-10
• The newborn is fed orally
• The newborn's birth weight is 2500 grams and above
• Phototherapy treatment is terminated and followed up
• Receiving nutritional support for hyperbilirubinemia
• No health problems other than hyperbilirubinemia
• Stable general health status

Sponsors & Collaborators

• meral güven: lead
• Ataturk University: collaborator

Study Sites (1)

Igdir University

Iğdır, Merkez, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• meral güven

  Igdir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Since the study participants were newborns, the participants were naturally blinded to the study. Due to the nature of the study, the researcher who applied the nursing intervention to the experimental groups could not be blinded to which group the babies were assigned to. However, blinding was done for the other researchers and the statistical process in the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: research assistant

Model Details: The study consisted of 3 groups: control group, dry whole body massage group and oily whole body massage group.

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: October 8, 2024
• Study Start: September 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)