Clinical trial NCT06706804: The Effect of Wiping Bath Training on Early Bathing, Body Temperature and Umbilical Cord Fall Time in Newborns
Official title: The Effect of Wiping Bath Training on Early Bathing, Body Temperature and Umbilical Cord Fall Time in Newborns: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wiping Bath
Education
Newborn
Keywords: Education
Newborn
Newborn bathing
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to examine the effects of wiping bath training on early bathing, body temperature and umbilical cord shedding time in newborns. This study was planned in a randomized controlled experimental research design. The study will be conducted with pregnant women who applied to the pregnancy schools of Kahramanmaraş Necip Fazıl City Hospital Gynecology and Obstetrics Additional Service building. When calculating the sample size, a similar study previously conducted on the subject was taken as a reference and the G\*Power 3.1.9.7 program was used (Ayyıldız et al, 2015). In the calculation made; the sample size of the study was found to be at least 36, and considering the parametric distribution, it was planned to complete the study with a total of 60 people, 30 in each group. Considering the possible case losses (10%), it is planned to include a total of 66 women (intervention group: 33, control group: 33). In the study, women will be assigned to groups according to the previously determined randomization number sequences, and then the Pregnant Information Form will be filled out by the participants using the face-to-face interview method. The determined practices will be carried out according to the group to which the participants are assigned. The hospital's pregnancy information class will be used for the training, and if there is another planned training in the pregnancy school, an empty room determined by the hospital administration will be used. The pregnant women in the intervention group will be explained the newborn wiping and bathing application stages by the researcher in groups of 2-3 people on a newborn model, and then the pregnant women will be asked to apply the bath individually on the model. The pregnant women in the control group will be subject to routine hospital protocol and no other intervention will be made. After the birth, the participants will be called by phone and the "Newborn Characteristics Information Form" will be filled out by phone and the participants will be asked to provide information by phone message after the umbilical cord falls off. After the umbilical cord falls off, the participants will be called by phone and the first bath time, umbilical cord falling off time and the body temperature of their babies (before the bath, immediately after the bath and 10 minutes after the bath) will be recorded by asking the mothers on the given follow-up form.

Detailed description: This study will be conducted in a randomized controlled experimental research design.

Eligibility criteria: Inclusion Criteria

* Infants of women who can speak and understand Turkish,
* who are literate, who are between 38-40 weeks of gestation,
* who have a healthy pregnancy,
* who can be followed up in the postpartum period by obtaining contact information, -who have a thermometer that can measure their baby's temperature at home, ---
* whose mothers do not have chronic-systemic diseases, hepatitis, acquired immunodeficiency syndrome and genital infections,
* who voluntarily agree to participate in the study and give written informed consent will be included in the study.

Exclusion Criteria

* Newborns with a gestational age below 37 weeks,
* birth weight below 2500 grams,
* premature rupture of membranes in the mother,
* congenital defects,
* need for intensive care or hospitalization,
* impaired skin integrity or skin problems and newborns whose mothers could not be contacted after birth will be excluded from the study.

Primary outcomes:
measure: Early Bathing Rate
timeFrame: 2 weeks after birth
measure: Newborn Body Temperature
timeFrame: 2 weeks after birth
measure: The duration of umbilical cord fall
timeFrame: 2 weeks after birth
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gupta P, Nagesh K, Garg P, Thomas J, Suryawanshi P, Sethuraman G, Hazarika RD, Verma RJ, Kumar CS, Kumari S, Taneja S, Chavhan V, Thakor P, Pandita A. Evidence-Based Consensus Recommendations for Skin Care in Healthy, Full-Term Neonates in India. Pediatric Health Med Ther. 2023 Aug 25;14:249-265. doi: 10.2147/PHMT.S414091. eCollection 2023.
citation: Gozen D, Caka SY, Besirik SA, Perk Y. First bathing time of newborn infants after birth: A comparative analysis. J Spec Pediatr Nurs. 2019 Apr;24(2):e12239. doi: 10.1111/jspn.12239. Epub 2019 Mar 19.