NCT04602130

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

September 17, 2020

Last Update Submit

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

EXPERIMENTAL

Massages 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.

Other: ControlOther: Sponge BathingOther: Tub Bathing

Sponge Bathing

EXPERIMENTAL

In 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

Other: ControlOther: MassageOther: Tub Bathing

Tub bathing

EXPERIMENTAL

In 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.

Other: ControlOther: MassageOther: Sponge Bathing

Control

NO INTERVENTION

The 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

ControlOTHER

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."

Also known as: Control Group
MassageSponge BathingTub bathing
MassageOTHER

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."

Also known as: Massage Group
Sponge BathingTub bathing

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."

Also known as: Sponge Bathing Group
MassageTub bathing

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."

Also known as: Tub Bathing Group
MassageSponge Bathing

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Study Sites (1)

Yeliz SUNA DAĞ

Malatya, 44000, Turkey (Türkiye)

Location

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: 22375955BACKGROUND
  • Ala, 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.

    RESULT
  • Ar 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.

  • Association of Women's Health Obstetric and Neonatal Nurses, & (AWHONN). (2013). Neonatal skin care: Evidence-based clinical practice guideline. Washington: AWHONN

    RESULT
  • Blume-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.

  • Bryanton 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.

  • Conk, Z., Başbakkal, Z., Bal Yılmaz, H., & Bolışık, B. (Eds.). (2013). Çocuk Sağlığı ve Hastalıkları Hemşireliği (Akademisye). Ankara.

    RESULT
  • Caka 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.

  • Çavuşoğlu, H. (2013). Çocuk Sağlığı ve Hastalıkları Hemşireliği (Sistem Ofs). Ankara.

    RESULT
  • Darmstadt GL, Dinulos JG. Neonatal skin care. Pediatr Clin North Am. 2000 Aug;47(4):757-82. doi: 10.1016/s0031-3955(05)70239-x.

  • Diego 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.

  • Diego 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.

  • Jain 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.

  • Kurtulan Bulut, H. (2009). Prematüre Bebeklerde İki Banyo Yönteminin Fizyolojik Ölçüm Sonuçlarına Etkisi. Dokuz Eylül Üniversitesi.

    RESULT
  • Lee 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.

  • 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.

  • Mangalgi, 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

    RESULT
  • Medves 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.

  • Morelius 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.

  • Smith 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.

  • Sülü Uğurlu, E. (2011). Aşı Uygulanan Bebeklerde Ağrının Giderilmesinde Bacak Masajının Etkisinin İncelenmesi. Dokuz Eylül Üniversitesi.

    RESULT
  • Tasdemir 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.

  • Törüner, E. ., & Lale, B. (2011). Çocuk sağlığı: temel hemşirelik yaklaşımları (Göktuğ yay). Ankara.

    RESULT
  • Varda 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.

  • Yıldız, S. (2008). İlk günden sonraki bakım. İçinde: Temel neonatoloji ve hemşirelik ilkeleri. (T. Dağoğlu & G. Görak, Eds.) (Nobel Tıp). İstanbul.

    RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Control GroupsMassage

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

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

Locations