The Effect of Massage, Wipe Bathing and Tub Bathing on Physiological Measurements of Late Premature Newborns
1 other identifier
interventional
192
1 country
1
Brief Summary
Purpose: This randomized experimental study aimed to analyze the effect of massage, wipe bathing and tub bathing of late premature newborns on their physiological measurements. Design and Methods: . This randomized experimental study was conducted on 192 newborns at the gestational week of 34 or higher in the newborn intensive care unit of a university hospital. The researcher applied massage (n: 48), tub bathing (n: 48), and wipe bathing (n: 48) to the newborns. The control group (n: 48) received no intervention except for the routine clinical practices. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form." The statistical analysis was performed using percentages, means, and ANOVA test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFirst Submitted
Initial submission to the registry
September 17, 2020
CompletedFirst Posted
Study publicly available on registry
October 26, 2020
CompletedOctober 28, 2020
October 1, 2020
11 months
September 17, 2020
October 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in pulse
Nurses recorded the changes in pulse(HR) of newborns before, immediately after and 30 minutes after the intervention on the Newborn Follow up Survey.
30 minutes
Secondary Outcomes (3)
Changes in respiration
30 minutes
:Changes in oxygen saturation
30 minutes
Changes in body temperature
30 minutes
Study Arms (4)
Massage
EXPERIMENTALMassages were performed starting from the face, focused on the newborns forehead, and then around the eyes and cheeks with gentle touches. Then, newborns' chest area and the upper and lower extremities were massaged. Finally, newborns'were placed prone position and the back was massaged. Nurses recorded newborns' physiological measurements (pulse, respiration, oxygen saturation and body temperature) on the Newborn Follow-up Form.
Sponge Bathing
EXPERIMENTALIn the sponge bathing group, the newborns' eyes, faces (outward from the midline), around the ear and the back of the ear were wiped from the inside out with cotton wipes and dried. Then, the chest area and arms, abdomen and back, legs and feet, respectively, were wiped and dried. Finally, the genital area was cleaned, before diapering the newborn. Nurses recorded newborns' physiological measurements (pulse, respiration, oxygen saturation and body temperature) on the Newborn Follow-up Form
Tub bathing
EXPERIMENTALIn the tub bathing group, before being immersed in the tub, the newborns' faces and heads were cleaned outwards from the midline and dried. Then, the neck, chest, arms, back, legs and genital area were soaped, before the full body was rinsed and dried. Finally, umbilical cord care was performed, and the baby was diapered. Nurses recorded the newborns' physiological measurements (pulse, respiration, oxygen saturation and body temperature) on the Newborn Follow-up Form.
Control
NO INTERVENTIONThe newborns in the control group did not undergo any intervention other than standard clinical practices. All physiological measurements (pulse, respiration, oxygen saturation and body temperature) were performed by nurses and recorded on the Newborn Follow-up Form.
Interventions
The control group (n: 48) received no intervention except for the routine clinical practices. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form."
The researcher applied massage (n: 48) to the newborns. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form."
The researcher applied sponge bathing (n: 48) to the newborns. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form."
The researcher applied tub bathing (n: 48) to the newborns. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form."
Eligibility Criteria
You may qualify if:
- newborns who born at 34 weeks' gestation and over
- newborns who receiving routine care and who were stable (temperature \>36.5 °C, SpO2\> 95%, HR = 120-160 / min)
- newborns who had an apgar score of 7 or higher at the first minute after birth;
- newborns who at least 24 hours old
You may not qualify if:
- newborns with any health problems that prevent bathing (eg congenital anomaly, surgical intervention, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inonu Universitylead
Study Sites (1)
Yeliz SUNA DAĞ
Malatya, 44000, Turkey (Türkiye)
Related Publications (25)
Loring C, Gregory K, Gargan B, LeBlanc V, Lundgren D, Reilly J, Stobo K, Walker C, Zaya C. Tub bathing improves thermoregulation of the late preterm infant. J Obstet Gynecol Neonatal Nurs. 2012 Mar;41(2):171-179. doi: 10.1111/j.1552-6909.2011.01332.x. Epub 2012 Feb 29.
PMID: 22375955BACKGROUNDAla, H., Thaer, M., & Dina, S. (2010). The Effect of Timing of Initial Bath on Newborn's Temperature. Middle East Journal of Nursing, 4(3), 16-19.
RESULTAr I, Gozen D. Effects of Underrunning Water Bathing and Immersion Tub Bathing on Vital Signs of Newborn Infants: A Comparative Analysis. Adv Neonatal Care. 2018 Dec;18(6):E3-E12. doi: 10.1097/ANC.0000000000000484.
PMID: 30507829RESULTAssociation of Women's Health Obstetric and Neonatal Nurses, & (AWHONN). (2013). Neonatal skin care: Evidence-based clinical practice guideline. Washington: AWHONN
RESULTBlume-Peytavi U, Lavender T, Jenerowicz D, Ryumina I, Stalder JF, Torrelo A, Cork MJ. Recommendations from a European Roundtable Meeting on Best Practice Healthy Infant Skin Care. Pediatr Dermatol. 2016 May;33(3):311-21. doi: 10.1111/pde.12819. Epub 2016 Feb 26.
PMID: 26919683RESULTBryanton J, Walsh D, Barrett M, Gaudet D. Tub bathing versus traditional sponge bathing for the newborn. J Obstet Gynecol Neonatal Nurs. 2004 Nov-Dec;33(6):704-12. doi: 10.1177/0884217504270651.
PMID: 15561658RESULTConk, Z., Başbakkal, Z., Bal Yılmaz, H., & Bolışık, B. (Eds.). (2013). Çocuk Sağlığı ve Hastalıkları Hemşireliği (Akademisye). Ankara.
RESULTCaka SY, Gozen D. Effects of swaddled and traditional tub bathing methods on crying and physiological responses of newborns. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12202. Epub 2017 Nov 21.
PMID: 29160925RESULTÇavuşoğlu, H. (2013). Çocuk Sağlığı ve Hastalıkları Hemşireliği (Sistem Ofs). Ankara.
RESULTDarmstadt GL, Dinulos JG. Neonatal skin care. Pediatr Clin North Am. 2000 Aug;47(4):757-82. doi: 10.1016/s0031-3955(05)70239-x.
PMID: 10943256RESULTDiego MA, Field T, Hernandez-Reif M. Vagal activity, gastric motility, and weight gain in massaged preterm neonates. J Pediatr. 2005 Jul;147(1):50-5. doi: 10.1016/j.jpeds.2005.02.023.
PMID: 16027695RESULTDiego MA, Field T, Hernandez-Reif M. Temperature increases in preterm infants during massage therapy. Infant Behav Dev. 2008 Jan;31(1):149-52. doi: 10.1016/j.infbeh.2007.07.002. Epub 2007 Aug 9.
PMID: 17692385RESULTJain S, Kumar P, McMillan DD. Prior leg massage decreases pain responses to heel stick in preterm babies. J Paediatr Child Health. 2006 Sep;42(9):505-8. doi: 10.1111/j.1440-1754.2006.00912.x.
PMID: 16925535RESULTKurtulan Bulut, H. (2009). Prematüre Bebeklerde İki Banyo Yönteminin Fizyolojik Ölçüm Sonuçlarına Etkisi. Dokuz Eylül Üniversitesi.
RESULTLee HK. Effects of sponge bathing on vagal tone and behavioural responses in premature infants. J Clin Nurs. 2002 Jul;11(4):510-9. doi: 10.1046/j.1365-2702.2002.00594.x.
PMID: 12100647RESULTLin 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.
PMID: 26607061RESULTMangalgi, S., & Upadhya, N. (2014). Variation of Body Temperature After Sponge Bath in Stable Very Low Birth Weight Preterm Neonates. Indian J Child Health, 4(2), 221-224. https://doi.org/10.4158/EP13328.OR
RESULTMedves JM, O'Brien B. The effect of bather and location of first bath on maintaining thermal stability in newborns. J Obstet Gynecol Neonatal Nurs. 2004 Mar-Apr;33(2):175-82. doi: 10.1177/0884217504263081.
PMID: 15095796RESULTMorelius E, Hellstrom-Westas L, Carlen C, Norman E, Nelson N. Is a nappy change stressful to neonates? Early Hum Dev. 2006 Oct;82(10):669-76. doi: 10.1016/j.earlhumdev.2005.12.013. Epub 2006 Feb 28.
PMID: 16507341RESULTSmith SL, Haley S, Slater H, Moyer-Mileur LJ. Heart rate variability during caregiving and sleep after massage therapy in preterm infants. Early Hum Dev. 2013 Aug;89(8):525-9. doi: 10.1016/j.earlhumdev.2013.01.004. Epub 2013 Jan 27.
PMID: 23361061RESULTSülü Uğurlu, E. (2011). Aşı Uygulanan Bebeklerde Ağrının Giderilmesinde Bacak Masajının Etkisinin İncelenmesi. Dokuz Eylül Üniversitesi.
RESULTTasdemir HI, Efe E. The effect of tub bathing and sponge bathing on neonatal comfort and physiological parameters in late preterm infants: A randomized controlled trial. Int J Nurs Stud. 2019 Nov;99:103377. doi: 10.1016/j.ijnurstu.2019.06.008. Epub 2019 Jun 21.
PMID: 31442786RESULTTörüner, E. ., & Lale, B. (2011). Çocuk sağlığı: temel hemşirelik yaklaşımları (Göktuğ yay). Ankara.
RESULTVarda KE, Behnke RS. The effect of timing of initial bath on newborn's temperature. J Obstet Gynecol Neonatal Nurs. 2000 Jan-Feb;29(1):27-32. doi: 10.1111/j.1552-6909.2000.tb02753.x.
PMID: 10660274RESULTYıldız, S. (2008). İlk günden sonraki bakım. İçinde: Temel neonatoloji ve hemşirelik ilkeleri. (T. Dağoğlu & G. Görak, Eds.) (Nobel Tıp). İstanbul.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 17, 2020
First Posted
October 26, 2020
Study Start
January 1, 2018
Primary Completion
November 18, 2018
Study Completion
December 31, 2018
Last Updated
October 28, 2020
Record last verified: 2020-10