The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy

Hyperbilirubinemia, Neonatal Clinical Trial

Official title:

The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05356273
• Other study ID #: 2021/84
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: September 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: It has been reported in the current literature that massage has various positive physiological effects on the newborn. Also baby massage; It increases the collection and excretion of waste products such as bilirubin by accelerating the flow of blood, lymph and tissue fluids. Our aim is to investigate the effect of infant massage on hyperbilirubinemia in newborns receiving phototherapy. Method: The population of the study consisted of babies who were hospitalized in Istanbul Haseki Training and Research Hospital Neonatal Intensive Care Unit between October 2021 and January 2022 and needed phototherapy. Transcutaneous bilirubin device and data collection form were used to obtain the data. 61 newborns who met the study criteria were randomly divided into experimental (n=30) and control (n=31) groups. Phototherapy was applied to all babies twice a day. In addition to phototherapy, infant massage was applied to the experimental group for 10 minutes just before the phototherapy. Bilirubin level measurements were made 2 hours after the end of phototherapy for both groups. Diaper changes for both groups were carried out 8 times a day, every 3 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

Inclusion Criteria:

• Born between 37-42 gestational weeks
• Birth weight between 2500-4000gr
• 1st and 5th Apgar score between 7-10
• Needing phototherapy treatment
• Diagnosed with indirect hyperbilirubinemia 24 hours or more after birth
• Orally fed
• No health problems other than indirect hyperbilirubinemia
• Newborns who has stable vital signs

Exclusion Criteria:

• ABO blood incompatibility or Rh incompatibility
• Diagnosed with direct hyperbilirubinemia
• Newborns who has skin anomaly
• Needing fluid replacement
• Newborns with gastrointestinal disorders

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal

Intervention

Procedure:
• Baby massage
Starting from the baby's face first, then the abdomen and chest, back, upper extremities and finally the lower extremities were massaged with semi-circular movements, respectively.

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (17)

Ahmadipour S, Mardani M, Mohsenzadeh A, Baharvand P, Nazeri MG. The Lowering of Bilirubin Levels in Full-Term Newborns by the Effect of Combined Massage Therapy and Phototherapy Practice. Am J Perinatol. 2019 Apr 18. doi: 10.1055/s-0039-1685493. [Epub ahe — View Citation

Amos RC, Jacob H, Leith W. Jaundice in newborn babies under 28 days: NICE guideline 2016 (CG98). Arch Dis Child Educ Pract Ed. 2017 Aug;102(4):207-209. doi: 10.1136/archdischild-2016-311556. Epub 2017 Feb 8. — View Citation

Anderson NB, Calkins KL. Neonatal Indirect Hyperbilirubinemia. Neoreviews. 2020 Nov;21(11):e749-e760. doi: 10.1542/neo.21-11-e749. Review. — View Citation

Basiri-Moghadam M, Basiri-Moghadam K, Kianmehr M, Jani S. The effect of massage on neonatal jaundice in stable preterm newborn infants: a randomized controlled trial. J Pak Med Assoc. 2015 Jun;65(6):602-6. — View Citation

Dalili H, Sheikhi S, Shariat M, Haghnazarian E. Effects of baby massage on neonatal jaundice in healthy Iranian infants: A pilot study. Infant Behav Dev. 2016 Feb;42:22-6. doi: 10.1016/j.infbeh.2015.10.009. Epub 2015 Nov 29. — View Citation

Eghbalian F, Rafienezhad H, Farmal J. The lowering of bilirubin levels in patients with neonatal jaundice using massage therapy: A randomized, double-blind clinical trial. Infant Behav Dev. 2017 Nov;49:31-36. doi: 10.1016/j.infbeh.2017.05.002. Epub 2017 J — View Citation

Garg BD, Kabra NS, Balasubramanian H. Role of massage therapy on reduction of neonatal hyperbilirubinemia in term and preterm neonates: a review of clinical trials. J Matern Fetal Neonatal Med. 2019 Jan;32(2):301-309. doi: 10.1080/14767058.2017.1376316. E — View Citation

Gözen D, Yilmaz ÖE, Dur S, Çaglayan S, Tastekin A. Transcutaneous bilirubin levels of newborn infants performed abdominal massage: A randomized controlled trial. J Spec Pediatr Nurs. 2019 Apr;24(2):e12237. doi: 10.1111/jspn.12237. Epub 2019 Feb 28. — View Citation

Korkmaz G, Esenay FI. Effects of Massage Therapy on Indirect Hyperbilirubinemia in Newborns Who Receive Phototherapy. J Obstet Gynecol Neonatal Nurs. 2020 Jan;49(1):91-100. doi: 10.1016/j.jogn.2019.11.004. Epub 2019 Dec 6. — View Citation

Lei M, Liu T, Li Y, Liu Y, Meng L, Jin C. Effects of massage on newborn infants with jaundice: A meta-analysis. Int J Nurs Sci. 2018 Jan 31;5(1):89-97. doi: 10.1016/j.ijnss.2018.01.004. eCollection 2018 Jan 10. Review. Erratum in: Int J Nurs Sci. 2020 Dec — View Citation

Lin CH, Yang HC, Cheng CS, Yen CE. Effects of infant massage on jaundiced neonates undergoing phototherapy. Ital J Pediatr. 2015 Nov 25;41:94. doi: 10.1186/s13052-015-0202-y. — View Citation

Lori Kenari R, Aziznejadroshan P, Haghshenas Mojaveri M, Hajian-Tilaki K. Comparing the effect of kangaroo mother care and field massage on serum bilirubin level of term neonates with hyperbilirubinemia under phototherapy in the neonatal ward. Caspian J I — View Citation

Mitra S, Rennie J. Neonatal jaundice: aetiology, diagnosis and treatment. Br J Hosp Med (Lond). 2017 Dec 2;78(12):699-704. doi: 10.12968/hmed.2017.78.12.699. Review. — View Citation

Montgomery P, Grant S, Mayo-Wilson E, Macdonald G, Michie S, Hopewell S, Moher D; CONSORT-SPI Group. Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension. Trials. 2018 Jul 31;19(1):407. doi: 10.1186/s13063-018-2733-1. — View Citation

Olusanya BO, Kaplan M, Hansen TWR. Neonatal hyperbilirubinaemia: a global perspective. Lancet Child Adolesc Health. 2018 Aug;2(8):610-620. doi: 10.1016/S2352-4642(18)30139-1. Epub 2018 Jun 28. Review. — View Citation

Pace EJ, Brown CM, DeGeorge KC. Neonatal hyperbilirubinemia: An evidence-based approach. J Fam Pract. 2019 Jan/Feb;68(1):E4-E11. Review. — View Citation

Zhang M, Wang L, Wang Y, Tang J. The influence of massage on neonatal hyperbilirubinemia: a meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2019 Sep;32(18):3109-3114. doi: 10.1080/14767058.2018.1455183. Epub 2018 Apr 9. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bilirubin levels	decreasing bilirubin levels within intervention times	72 hours
Secondary	Stool frequency	increasing stool frequency within intervention times	72 hours