Clinical trial NCT06166485: The Effect of Bath Applied in Two Different Sequences on Stress Level and Physiological Parameters in Term Babies
Official title: The Effect of Bath Applied in Two Different Sequences on Stress Level and Physiological Parameters in Term Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn
Keywords: baby health
stress
newborn bath
newborn
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 104
Sex: ALL
Minimum age (years): 37
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study was planned as a randomized controlled experimental study. Computer-assisted randomization will be used to create groups (https://www.randomizer.org/). Power analysis was performed using the G\*Power (v3.1.9) program to determine the sample size. The power of the study is expressed as 1-β (β = probability of type II error) and in general, studies must have 80% power.
Primary purpose: OTHER

Brief summary: In this study, the bath applied to term babies in two different orders (first washing the body and lastly the head, and the classical method in which the whole body is washed starting from the head first), the babies' stress level, physiological parameters (body temperature, pulse, respiration, O2 saturation), procedure time (time of bathing). ) was planned to determine its effect on the calming time of babies.

The effects of two different bathing methods given to healthy and term babies on the babies' stress level, physiological parameters (body temperature, pulse, respiration, O2 saturation), procedure time (bathing time), and calming time of the babies will be compared.

Detailed description: The researcher will briefly talk about the scope and content of the research by meeting with the parents of babies who meet the selection criteria to apply the first bath of term and healthy babies before discharge, at the earliest 6 hours after birth.

Healthy, term newborns will be divided into two groups, one group will be washed from body to head, and the other group will be washed from head to body, which is the traditional method. In the study, the stress levels of babies will be obtained by observing the newborns independently by two different observer nurses before, after and after the procedure, using the "Newborn Stress Scale", at the 5th, 15th and 30th minutes. Physiological parameters of the babies will be evaluated before the procedure, during the procedure, and at the 1st, 5th and 15th minutes after the procedure. Bathing will be done by the same person (researcher) for all babies in both the experimental and control groups.

Pulse oximeter and stopwatch will be used to measure physiological parameters (heart rate, oxygen saturation, calming time).

Eligibility criteria: Inclusion Criteria:

* 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
* Having a healthy term baby.

Exclusion Criteria:

* Meconium aspiration etc. washed immediately after birth for various reasons,
* Having various health problems,
* Their parents did not agree to participate in the study,
* Low birth weight and premature babies

Primary outcomes:
measure: Newborn stress scale
timeFrame: This scale evaluation will be applied to healthy, term babies who are hospitalized in the neonatal clinic within a 3-month period and the study will be conducted.
measure: Data collection form
timeFrame: The 36-question data collection form will be applied to the mother of the baby on whom the study will be conducted and to the observers making the evaluation within 3 months of data collection.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa
Study officials:
References:
citation: Huang Y, Zhou L, Abdillah H, Hu B, Jiang Y. Effects of swaddled and traditional tub bathing on stress and physiological parameters of preterm infants: A randomized clinical trial in China. J Pediatr Nurs. 2022 May-Jun;64:e154-e158. doi: 10.1016/j.pedn.2021.11.028. Epub 2021 Dec 23.
citation: Kusari A, Han AM, Virgen CA, Matiz C, Rasmussen M, Friedlander SF, Eichenfield DZ. Evidence-based skin care in preterm infants. Pediatr Dermatol. 2019 Jan;36(1):16-23. doi: 10.1111/pde.13725. Epub 2018 Dec 12.
citation: Fernandez D, Antolin-Rodriguez R. Bathing a Premature Infant in the Intensive Care Unit: A Systematic Review. J Pediatr Nurs. 2018 Sep-Oct;42:e52-e57. doi: 10.1016/j.pedn.2018.05.002. Epub 2018 May 18.
citation: Moser WJ, Bilka KR, Vrouwe SQ, Glick JC, Ramaiah V. Running water while bathing is a risk factor for pediatric scald burns. Burns. 2023 Nov;49(7):1714-1718. doi: 10.1016/j.burns.2023.03.014. Epub 2023 Mar 23.
citation: 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.
citation: 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.