NCT06661408

Brief Summary

This study will be conducted in a randomized controlled experimental research design with pretest, posttest control group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

September 17, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

October 28, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

September 17, 2024

Last Update Submit

October 25, 2024

Conditions

Keywords

NewbornBathingPrimiparEducation

Outcome Measures

Primary Outcomes (3)

  • Knowledge Level of Mothers on Newborn Bathing

    The Newborn Bathing Knowledge Test was developed by the researchers based on the literature to determine the knowledge levels of mothers about newborn bathing. In the knowledge test, there are a total of 20 questions under 10 main topics including "bath time, bathing materials, ambient temperature, water temperature, umbilical cord care, soap and shampoo use, maintaining newborn body temperature, bathing procedure sequence, safety during bathing, drying after bathing and dressing". The questions were prepared in multiple-choice and true/false design, and each question had only one correct answer. The women\'s answers to the questions were evaluated after the completion of the test and each correctly answered question was evaluated as five points and the total score ranged from 0-100. The higher the score obtained from the knowledge test, the higher the women\'s level of knowledge about newborn bathing.

    average 3 months

  • Anxiety level of women

    Anxiety level of women will be assessed by using Spielberger\'s State Anxiety Inventory. The scale was developed to measure the state anxiety levels of normal and abnormal individuals and adapted into Turkish by Öner and Le Compte. It is a self-assessment type scale consisting of short statements. The State Anxiety Inventory was developed to measure a person\'s anxiety at a specific moment and consists of 20 items. In the evaluation of the scale, it is accepted that those who score below 36 have no anxiety, those who score between 37 and 42 have mild anxiety and those who score 42 and above have high anxiety.

    average 3 months

  • Womens bonding levels

    Womens bonding level will be assessed using the Postpartum Bonding Questionnaire (PBQ). The PBQ was first developed to assess mother-infant attachment. It was revised to identify problems in the mother-infant relationship. The scale was adapted into Turkish by Dişsiz et al. in 2024. The six-point Likert-type scale has 21 items to measure the mothers attachment to the infant within a year. As the score obtained from the scale increases, the mothers bonding to the baby decreases.

    average 3 months

Study Arms (3)

Control Group

NO INTERVENTION

Pregnant women in the control group will be subjected to the routine hospital protocol without any other intervention. Pregnant women in this group are verbally informed about bathing during outpatient clinic follow-ups. After completing the post-test questions, the newborn bath application video will be transmitted to the women in this group on their phones and the disadvantageous situation of this group will be tried to be reduced.

Intervention group 1

EXPERIMENTAL

The women assigned to this group will be shown the newborn bath application video prepared by the researchers in groups of 2-4 people in the form of a projection presentation.

Behavioral: Intervention group 1

Intervention group 2

EXPERIMENTAL

In groups of 2, the researcher will first explain the stages of newborn bathing application by the researcher in the form of a projection presentation, and then the pregnant women will be provided to perform the newborn bathing application on the newborn bathing model and tools simultaneously with the researcher.

Behavioral: Intervention group 2

Interventions

The women assigned to this group will be shown the newborn bath application video prepared by the researchers in groups of 2-4 people in the form of a projection presentation.

Intervention group 1

In groups of 2, the researcher will first explain the stages of newborn bathing application by the researcher in the form of a projection presentation, and then the pregnant women will be provided to perform the newborn bathing application on the newborn bathing model and tools simultaneously with the researcher.

Intervention group 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Can speak and understand Turkish,
  • years of age or older,
  • Literate,
  • Primiparous,
  • In the third trimester of pregnancy,
  • A singleton pregnancy,
  • No psychiatric illness,
  • Who have not received any training on newborn bathing before,
  • Her baby was not diagnosed with a fetal anomaly,
  • With a smartphone and internet,
  • Residing in the province of Kahramanmaras and
  • Who agreed to participate in the research

You may not qualify if:

  • Preterm labor (\<37 weeks gestation),
  • Stillbirth,
  • The baby needs intensive care or is hospitalized,
  • The baby has a low birth weight (\<2500 grams),
  • The one whose baby\'s first bath was given by someone else,
  • A newborn bathing program was organized at the pregnancy school.
  • Wishing to leave at any stage of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

Related Publications (16)

  • WHO Recommendations on Postnatal Care of the Mother and Newborn. Geneva: World Health Organization; 2013 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK190086/

    PMID: 24624481BACKGROUND
  • Sarkar R, Basu S, Agrawal RK, Gupta P. Skin care for the newborn. Indian Pediatr. 2010 Jul;47(7):593-8. doi: 10.1007/s13312-010-0132-0.

    PMID: 20683112BACKGROUND
  • Roxanne B, Laura VDB, Yannic VG, Natacha VC, Luka VL, Kuipers YJ. Validation of the postpartum bonding questionnaire: A cross-sectional study among Flemish mothers. Midwifery. 2022 Apr;107:103280. doi: 10.1016/j.midw.2022.103280. Epub 2022 Feb 8.

    PMID: 35182820BACKGROUND
  • Öner N, Le Compte A. Süreksiz Durumluk/Sürekli Kaygı Envanteri El Kitabı. s: 1-26, 1. Basım Boğaziçi Üniversitesi Yayınları, İstanbul, 1983.

    BACKGROUND
  • Keten Edis E. Sağlık & Bilim 2022: Hemşirelik- IV. s. 95-103, 1. Basım, Efe Akademik Yayıncılık, İstanbul, 2022.

    BACKGROUND
  • Kayom VO, Kakuru A, Kiguli S. Newborn Care Practices among Mother-Infant Dyads in Urban Uganda. Int J Pediatr. 2015;2015:815938. doi: 10.1155/2015/815938. Epub 2015 Dec 2.

    PMID: 26713096BACKGROUND
  • Getachew G, Ibrahim IM, Mulugeta Y, Ahmed KY. Early newborn bathing and associated factors among mothers in Afar Region, Northeast Ethiopia. J Trop Pediatr. 2022 Dec 5;69(1):fmac117. doi: 10.1093/tropej/fmac117.

    PMID: 36625889BACKGROUND
  • Garcia Bartels N, Mleczko A, Schink T, Proquitte H, Wauer RR, Blume-Peytavi U. Influence of bathing or washing on skin barrier function in newborns during the first four weeks of life. Skin Pharmacol Physiol. 2009;22(5):248-57. doi: 10.1159/000235552. Epub 2009 Aug 18.

    PMID: 19690450BACKGROUND
  • Dissiz M, Bayri Bingol F, Demirgoz Bal M, Karacam Yilmaz ZD, Karakoc A, Bilgin Z. The Turkish version of the Postpartum Bonding Questionnaire (PBQ): Examination of the validity and reliability and scale structure. J Pediatr Nurs. 2024 Jul-Aug;77:131-139. doi: 10.1016/j.pedn.2024.03.012. Epub 2024 Mar 21.

    PMID: 38518689BACKGROUND
  • Dağoğlu T, Ovalı F. Yenidoğanın cilt bakımı. Neonatoloji. s.167-74, 2. Basım, Nobel Tıp Kitabevleri, İstanbul, 2007.

    BACKGROUND
  • Çalışır H, Güler F. Riskli Yenidoğanların cilt bakımında kanıta dayalı uygulamalar. Türkiye Klinikleri Hemşirelik Bilimleri Dergisi 2011; 3(2).

    BACKGROUND
  • Brockington IF, Oates J, George S, Turner D., Vostanis P, Sullivan M, ve ark. Screening questionnaire for mother-infant bonding disorders. Archives Of Women's Mental Health 2001; 3(4):133-140.

    BACKGROUND
  • Brandon D, Hill CM, Heimall L, Lund CH, Kuller J, McEwan T, New K. Neonatal skin care: evidence-based clinical practice guideline. Washington DC: Association of Women's Health, Obstetric and Neonatal Nurses 2018.

    BACKGROUND
  • Boran S, Kahriman İ, Polat SD. Exploring newborn bathing practices among mothers in the postpartum period. Genel Sağlık Bilimleri Dergisi 2024; 6(2):239-254.

    BACKGROUND
  • Blume-Peytavi U, Cork MJ, Faergemann J, Szczapa J, Vanaclocha F, Gelmetti C. Bathing and cleansing in newborns from day 1 to first year of life: recommendations from a European round table meeting. J Eur Acad Dermatol Venereol. 2009 Jul;23(7):751-9. doi: 10.1111/j.1468-3083.2009.03140.x.

    PMID: 19646134BACKGROUND
  • American Academy of Pediatricks 2023. https://www.healthychildren.org/English/ages-stages/baby/bathing-skin-care/Pages/Bathing-Your-Newborn.aspx: Erişim Tarihi: 19.08.2024.

    BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled experimental research
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 17, 2024

First Posted

October 28, 2024

Study Start

December 15, 2024

Primary Completion

July 15, 2025

Study Completion

August 15, 2025

Last Updated

October 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations