The Effect of Bath Applied in Two Different Sequences on Stress Level and Physiological Parameters in Term Babies
Phase: NA
Conditions: Newborn
Sponsor: Istanbul University - Cerrahpasa

 
 
 
 
 
 TR Istanbul University-Cerrahpaşa ID: İstanbulUCEdu  
  Study Protocol: June 1, 2023 
the effect of two different bathing methods on vital parameters 
oath stress levels in preterm babies . 
 Clinical Trial Number:  NCT06166485 

 
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                                    WORKING PROTOCOL 
Title / Date 
 The effect of bathing applied in two different orders on stress level and 
physiological parameters in term babies / 01.06.2023 
Approval of the education 
officer of the unit( s ) where the 
study will be carried out. 
Newborn Clinic 
Name and surname of the 
responsible investigator, e-mail 
address, mobile phone, 
signature 
Prof. dr . SEVİL İNAL 
inalsevil@gmail.com 
05334332824 
 
Assistant researcher name and 
surname, e-mail address, 
mobile phone, signature 
Ayşe Dilan Koöak 
aysedilankocak@gmail.com 
05345011210 
Assistant researcher name and 
surname, e-mail address, 
mobile phone, signature 
 
Financial agreements between 
the sponsor, principal 
investigator or research site 
 
main purpose, 
Secondary purpose, if any 
hypothesis ( es ) 
Main Purpose: This study was planned to determine the effect of bathing 
applied in two different orders (first the body and then the head, and the 
classical method of washing the whole body, starting from the head) on the 
stress level and physiological parameters of term babies. 
 
Hypotheses: 
-H0 Stress levels and physiological parameters of babies are similar in 
bathing methods performed from head to toe or head to toe. 
-H1. Babies' stress levels are higher when bathing in a sequence from head 
to toe compared to bathing where the head is left until the end. 
-H2. When bathing is performed in a sequence from head to toe, the baby's 
physiological parameters are more negatively affected than when the bath 
is left from head to end. 
-H3. In the bathing method in which the head is washed first, the time for 
babies to calm down is longer than in the method in which the head is 
washed last. 
-H4. The procedure time in the bath where the head is left last is shorter 
than in the bath method where the head is washed first. 
 
Medical condition/area of 
treatment investigated 
In this study; The effect of bathtub baths applied in two different orders on 
the stress level and physiological parameters of term babies will be 
investigated. No treatment will be applied. The research to be conducted is 
one of the baby care practices that are among the independent functions of 
the researchers who will conduct the research. The effect of baby bath 
applied with two different methods on healthy babies' stress level, 
physiological parameters, babies' calming time and procedure time will be 
investigated. 

 
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of the population to be 
examined (acceptance and 
exclusion criteria, age range by 
gender, termination criteria of 
the study when necessary) 
identification of subgroups, if 
any ) 
Criteria for inclusion in the research ; 
- The baby's body weight is between 2.5 - 4 kg 
- The baby's Apgar score is >7 
- The baby does not have any health problems 
- Their parents agree to participate in the study 
-Determined as a healthy term baby 
Exclusion criteria from the study ; 
- Meconium aspiration etc. washed immediately after birth for various 
reasons, 
- Having various health problems, 
-Their parents did not agree to participate in the study, 
-It was decided to exclude low birth weight and premature babies from the 
scope of the research. 
Independent variables; 
Traditional bathtub bathing from head to toe and bathtub bathing methods 
where the head is left last 
Dependent variables; 
Stress level of babies, physiological parameters (body temperature, pulse, 
respiration, O 2 saturation ), procedure time (bathing time), time for babies 
to calm down 
Design features (clinical trial / 
retrospective study / case) 
sample size, determination of 
the number of centers, study 
duration, 
if any randomization method 
and its importance 
Blindness method and its 
importance, if any 
This study was planned as a randomized controlled experimental study. 
Computer-assisted randomization will be used to create groups 
(https://www.randomizer.org/). To determine the sample size, power 
analysis was performed using the G* Power (v3. 1.9 ) program. The power 
of the study is expressed as 1-β (β = probability of type II error), and in 
general, studies must have 80% power. According to Cohen's (1988) effect 
size coefficients; Assuming that the evaluations to be made between two 
independent groups would have a medium effect size (d = 0.5), it was 
determined that there should be at least 64 people in each group, according 
to the calculation made using the t test. 
Address of the clinic, 
laboratory, other medical units 
and institutions, if any, 
from cases , processing of 
data/keeping records, 
evaluation criteria, 
quality control and quality 
assurance 
No samples will be taken from the babies forming the sample group. 
Statistical method to be applied 
The data obtained in the study were compiled using SPSS (Statistical 
Package for Social Sciences ) for Windows 25.0 program. In evaluating 
the data; Descriptive statistical methods will be used for number, 
percentage, min-max , mean and standard deviation values. 
 
The compliance of the obtained data with normal distribution will be 
tested. Compliance with normal distribution can be examined with the QQ 
Plot drawing ( Chan , 2003:280-285). In addition, normal distribution of 
the data used depends on the skewness and kurtosis values being between 
±3 ( Shao , 2002). 
In normally distributed data, when comparing quantitative data, 
independent t test will be applied for the difference between two 
independent groups, when comparing two dependent stages, dependent t 
test will be applied, and when comparing more than two dependent stages, 
analysis of variance in repeated measurements (MIX ANOVA ) will be 
applied and in case of a difference, Bonferroni will be applied to determine 
the group that makes the difference. will be used. Chi square analysis will 
be used to test the relationship between categorical variables. 

 
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List of publications: at least 2 
(copies will be on file) 
- Kuller , J. M. (2014). Update on newborn bathing _ newborn oath baby 
Nursing Reviews , 14(4), 166-170. 
-Lund, C. , Kuller , J., & Durand , D. J. (2020). Baby's first bath : Changes 
in skin barrier function after bathing full term _ newborns with water etc 
liquid baby cleaner . Pediatric Dermatology , 37(1), 115-119. 
-Ar, I. , & Gözen, D. (2018). Effects of underrunning water bathing oath 
immersion tub bathing on vital signs of newborn infants : a comparative 
analysis . Advances in Neonatal Care , 18(6), E3-E12. 
-Mohamed , SS A. , Faheim , SS, Farg , DSS, & Hassan, HE The 
relationship between Trunk-to-Head Bathing oath the Traditional Head-to-
Trunk Bathing on Newborns ' Outcome . 
-Johnson, E ., & Hunt , R. (2019). Infant skin care : updates oath 
recommendations . Current Opinion in Pediatrics , 31(4), 476-481. 
- Edraki , M ., Paran , M., Montaseri , S., Nejad , MR, & Montaseri , Z. 
(2014). comparing the effects of swaddled oath conventional bathing 
methods on body temperature oath crying duration in premature infants : a 
randomized clinical trial . Journal of caring sciences , 3(2), 83. 
-Huang , Y. , Zhou , L., Abdillah , H., Hu, B., & Jiang , Y. (2022). Effects 
of swaddled oath traditional tub bathing on stress oath physiological 
parameters of preterm infants : A randomized clinical trials in China . 
Journal of Pediatrics Nursing , 64, e154-e158. 
-Burdall , O. , Willgress , L., & Goad , N. (2019). Neonatal skin care : 
developments in care to maintain neonatal barrier function oath prevention 
of diaper dermatitis . Pediatric dermatology , 36(1), 31-35. 
-Lund, C. (2016). Bathing oath beyond : current bathing controversies for 
newborn infants . Advances in Neonatal Care , 16, S13-S20. 
-LEE, H.K. (2002). effects of sponge bathing on vagal tone oath 
behavioral responses in premature infants . Journal of clinical nursing , 
11(4), 510-519. 
-Şerbetçi, G. (2019). Determination of postpartum belly and skin care 
applications ( Master's thesis , Istanbul Medipol University Institute of 
Health Sciences). 
-Dağ, Y.S. (2017). Examining the effect of bathing and massage on 
hyperbilirubinemia in newborns ( Master's thesis , İnönü University 
Institute of Health Sciences). 
-Ceylan, S. S. , & Bolışık , ZB (2022). Baby Bathing in Neonatal Intensive 
Care Units: Recommendations for Neonatal Nurses. 
-So , H.S. , You , MA, Mun, JY, Hwang , MJ, Kim, HK, Pyeon , SJ, ... & 
Chang , BH (2014). Effect of trunk‐to‐head bathing on physiological 
responses in newborns . Journal of Obstetric , Gynecologic & Neonatal 
Nursing , 43(6), 742-751. 
-Uçar, E. , & Çınar, N. (2016). Newborn's First Bath: When Should It Be 
Done ? YILDIRIM BEYAZIT UNIVERSITY NURSING E-JOURNAL, 
3(1). 
-Kelly , P.A. , Classen , KA, Crandall , CG, Crenshaw , JT, Schaefer , SA, 
Wade , DA, ... & Fossee , KR (2018). Effect of timing _ _ first bath on a 
healthy newborn's temperature . Journal of Obstetric , Gynecologic & 
Neonatal Nursing , 47(5), 608-619. 
-Çaka, S. Y ., & Gözen, D. (2018). Effects of swaddled oath traditional tub 
bathing methods on crying oath physiological responses of newborns . 

 
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journal for Specialists in Pediatric Nursing , 23(1), e12202. 
-Ceylan, S. S. , & BOLIŞIK, B. (2017). Newborn Stress Scale 
Examination of Psychometric Properties. Acıbadem University Journal of 
Health Sciences, (2), 97-103. 
 
 
Relevant sources have been added to the bibliography file. 
 
 Summary of findings from 
studies conducted / supporting 
information for this study 
So et al. in 2014, investigating the effect of trunk-to-head bathing on the 
body temperature, heart rate and oxygen saturation of newborns compared 
to traditional head-to-torso bathing, it was found that stable and healthy 
term newborns bathed from trunk to head had lower body temperature 
before bathing than those bathed from head to trunk. It has been 
determined that they return to their temperatures faster ( So , HS et al. 
2014). 
 
 
In 2014, by Edraki et al., 50 premature babies in the neonatal intensive 
care unit were divided into two groups, experimental and control, by 
random distribution method. The babies in the experimental group were 
washed with the swaddle bath method, and the babies in the control group 
were washed with the traditional bath method. Body temperature was 
measured 10 minutes before and 10 minutes after bathing. Babies' faces 
were filmed during bathing to record their cries. The average temperature 
loss in newborns bathed with swaddle baths was lower than those bathed 
with traditional bathing methods. It was found to be significantly less than 
in newborns . Additionally, it was observed that the duration of crying was 
significantly less in the experimental group than in the control group. 
Considering the positive effect of swaddling on maintaining body 
temperature and reducing stress, it was concluded that it can be used as a 
suitable bathing method in the NICU ( Edraki, M. et al.). 
 
Mohamed et al. to compare the effect of trunk-to-head bathing with 
traditional head- to-trunk bathing on the body temperature, heart rate, and 
oxygen saturation of newborns , it was found that trunk-to-head bathing 
had positive effects on newborns' body temperature, heart rate, and oxygen 
saturation compared to traditional head-to-trunk bathing. ( Mohamed , SS 
A et al. 2018). 
 
The results of this limited number of studies are particularly healthy and at 
term. There are no consistent results regarding the order in which 
newborns should be bathed. This suggests that there is a need for well-
designed randomized controlled studies on this subject. Based on this 
literature review, this study was planned to determine the effect of bathing 
applied in two different orders (washing the body first and the head last, 
and the classical method of washing the whole body starting from the head 
first) on stress level, physiological parameters and crying duration in term 
babies. 
 

 
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Publication policy 
The research will be carried out in line with universal ethical principles. 
Parents of babies who meet the sample selection criteria will be 
interviewed and informed about the purpose and scope of the research, and 
their written consent will be obtained. Babies of parents who agree to 
participate in the study and who meet the sample selection criteria will be 
included in the study . The information obtained from the research will be 
used only as research data, the personal information of the baby and its 
parents will never be included, and confidentiality rules will be strictly 
followed.