Bundling Gentle Body Massage Along With Regular Position Change Under Phototherapy
NCT ID: NCT05260138
Last Updated: 2022-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-08-20
2021-12-18
Brief Summary
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Hypothesis
Full-term neonates with hyperbilirubinemia who receive gentle body massage along with regular position change exhibit less bilirubin level and better clinical outcomes than those who don't.
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Detailed Description
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The control group received the conventional NICU care of infants undergoing phototherapy. Phototherapy was given by single Blue LEDs emitting light in a narrow spectrum (450-470 nm). Initially, phototherapy lamps were checked and adjusted at the height of 30 cm from the neonates who were kept naked in the incubator/crib except for the reproductive organs with shielded eyes. The neonates were positioned supine under the phototherapy. The treatment was given continuously, except while feeding and nursing for 30 minutes every 3 hours. The neonates' skin was cleaned with warm water without applying any sorts of ointments oils or creams. They were also observed for signs of dehydration.
The intervention group received all basic routine care in addition to regular position change from supine to laterals under the phototherapy every two hours. They also received gentle body massage
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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The intervention group
received all basic routine care in addition to regular position change and gentle body massage
Gentle Body message
The intervention group received gentle body massage twice/day and position change from supine to lateral every two hours under the phototherapy for three consecutive days in addition to routine NICU care.
The control group
received the conventional NICU care
Routine NICU Care
received the conventional NICU care of infants undergoing phototherapy. Phototherapy was given by single Blue LEDs emitting light in a narrow spectrum (450-470 nm). Initially, phototherapy lamps were checked and adjusted at the height of 30 cm from the neonates who were kept naked in the incubator/crib except for the reproductive organs with shielded eyes. The neonates were positioned supine under the phototherapy. The treatment was given continuously, except while feeding and nursing for 30 minutes every 3 hours. The neonates' skin was cleaned with warm water without applying any sorts of ointments oils or creams. They were also observed for signs of dehydration.
Interventions
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Gentle Body message
The intervention group received gentle body massage twice/day and position change from supine to lateral every two hours under the phototherapy for three consecutive days in addition to routine NICU care.
Routine NICU Care
received the conventional NICU care of infants undergoing phototherapy. Phototherapy was given by single Blue LEDs emitting light in a narrow spectrum (450-470 nm). Initially, phototherapy lamps were checked and adjusted at the height of 30 cm from the neonates who were kept naked in the incubator/crib except for the reproductive organs with shielded eyes. The neonates were positioned supine under the phototherapy. The treatment was given continuously, except while feeding and nursing for 30 minutes every 3 hours. The neonates' skin was cleaned with warm water without applying any sorts of ointments oils or creams. They were also observed for signs of dehydration.
Eligibility Criteria
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Inclusion Criteria
* receive enteral feeding (breast, bottle, or mixed feeding, gavage)
* Newly admitted
Exclusion Criteria
* Required mechanical ventilation
* Has acute phase of circulatory insufficiency
* Hemolytic disease
* Neurological disorders
* Congenital anomalies
* Neonatal sepsis Diarrhea
1 Day
28 Days
ALL
Yes
Sponsors
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Alexandria University
OTHER
Responsible Party
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Zohour Ibrahim Mahmoud Rashwan
Lecturer
Locations
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Faculty of Nursing
Alexandria, , Egypt
Countries
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References
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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.
Chen A, Du L, Xu Y, Chen L, Wu Y. The effect of blue light exposure on the expression of circadian genes: bmal1 and cryptochrome 1 in peripheral blood mononuclear cells of jaundiced neonates. Pediatr Res. 2005 Dec;58(6):1180-4. doi: 10.1203/01.pdr.0000183663.98446.05.
Donneborg ML, Knudsen KB, Ebbesen F. Effect of infants' position on serum bilirubin level during conventional phototherapy. Acta Paediatr. 2010 Aug;99(8):1131-4. doi: 10.1111/j.1651-2227.2010.01885.x. Epub 2010 Jun 2.
Field TM, Schanberg SM, Scafidi F, Bauer CR, Vega-Lahr N, Garcia R, Nystrom J, Kuhn CM. Tactile/kinesthetic stimulation effects on preterm neonates. Pediatrics. 1986 May;77(5):654-8.
Kato S, Iwata O, Yamada Y, Kakita H, Yamada T, Nakashima H, Sugiura T, Suzuki S, Togari H. Standardization of phototherapy for neonatal hyperbilirubinemia using multiple-wavelength irradiance integration. Pediatr Neonatol. 2020 Feb;61(1):100-105. doi: 10.1016/j.pedneo.2019.07.002. Epub 2019 Aug 12.
Other Identifiers
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170301221
Identifier Type: -
Identifier Source: org_study_id
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