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Not yet recruitingNCT06661408NewbornBathingUpdated Oct 28, 2024

The Effects of Video-Based and Practical Newborn Bathing Education Provided to Primiparous Pregnant Women During the Third Trimester on Knowledge, Anxiety, and Bonding During the First Bath: a Randomized Controlled Trial

An interventional study of Intervention group 1 and Intervention group 2 in Newborn Bathing, Primiparous Pregnant Women and Anxiety, sponsored by Kahramanmaras Sutcu Imam University. Not yet recruiting at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-28.

Sponsored by Kahramanmaras Sutcu Imam University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Newborn Bathing
  • Primiparous Pregnant Women
  • Anxiety
  • Bonding
  • Knowledge

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Keywords

  • Newborn
  • Bathing
  • Primipar
  • Education
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's planned enrollment of 144 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Kahramanmaras Sutcu Imam University is the lead sponsor of 192 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Can speak and understand Turkish,
  • 18 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
144 participants (estimated)

Study arms

  • No intervention
    Control Group

    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.

  • Experimental
    Intervention group 1

    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

  • Experimental
    Intervention group 2

    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

  • BehavioralIntervention group 1

    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.

  • BehavioralIntervention group 2

    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.

06

What researchers measure

Primary outcomes

  1. 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\&#39;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\&#39;s level of knowledge about newborn bathing.

    Time frame: average 3 months

  2. Anxiety level of women

    Anxiety level of women will be assessed by using Spielberger\&#39;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\&#39;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.

    Time frame: average 3 months

  3. 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.

    Time frame: average 3 months

07

Study locations

1 site
  • Kahramanmaras Sutcu Imam University
    Kahramanmaras, Turkey
08

References and documents

Publications

  • 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/ PubMed 24624481 ↗
  • 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. PubMed 20683112 ↗
  • 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. PubMed 35182820 ↗
  • Öner N, Le Compte A. Süreksiz Durumluk/Sürekli Kaygı Envanteri El Kitabı. s: 1-26, 1. Basım Boğaziçi Üniversitesi Yayınları, İstanbul, 1983.
  • Keten Edis E. Sağlık & Bilim 2022: Hemşirelik- IV. s. 95-103, 1. Basım, Efe Akademik Yayıncılık, İstanbul, 2022.
  • 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. PubMed 26713096 ↗
  • 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. PubMed 36625889 ↗
  • 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. PubMed 19690450 ↗
  • 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. PubMed 38518689 ↗
  • Dağoğlu T, Ovalı F. Yenidoğanın cilt bakımı. Neonatoloji. s.167-74, 2. Basım, Nobel Tıp Kitabevleri, İstanbul, 2007.
  • Çalışır H, Güler F. Riskli Yenidoğanların cilt bakımında kanıta dayalı uygulamalar. Türkiye Klinikleri Hemşirelik Bilimleri Dergisi 2011; 3(2).
  • 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.
  • 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.
  • 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.
  • 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. PubMed 19646134 ↗
  • 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.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06661408
Lead sponsor
Kahramanmaras Sutcu Imam University
Responsible party
Çağla KILIÇ (Research Assistant, Kahramanmaras Sutcu Imam University) — Principal investigator
First posted
Oct 28, 2024
Start date
Dec 15, 2024 (estimated)
Primary completion
Jul 15, 2025 (estimated)
Completion
Aug 15, 2025 (estimated)
Last update
Oct 28, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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