Newborn BathingNewbornBathingNCT06661408
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
A study testing Intervention group 1 and Intervention group 2 in people with Newborn Bathing and Primiparous Pregnant Women, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted in a randomized controlled experimental research design with pretest, posttest control group. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Newborn Bathing, Primiparous Pregnant Women, Anxiety
- What is being tested?
- Intervention group 1 and Intervention group 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Can speak and understand Turkish,
- 18 years of age or older,
- Literate,
- Primiparous,
- In the third trimester of pregnancy,
- A singleton pregnancy,
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University
Kahramanmaraş
About this study
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.
- Conditions
- Newborn Bathing, Primiparous Pregnant Women, Anxiety, Bonding, Knowledge
- Being tested
- Intervention group 1, Intervention group 2
- Keywords
- Newborn, Bathing, Primipar, Education
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group 1Behavioural
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 2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Intervention group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: average 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Newborn BathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled experimental research
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağla KILIÇ, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661408
- Sponsor's protocol ID
- 185
- Other IDs
- TUBITAK or KSU BAP
- Acronym
- NewbornBathing
- Status last verified
- Aug 2024
- First submitted
- 17 Sep 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Health Organisation (WHO) (2013) Guidelines Approved by the Guidelines Review Committee, in WHO recommendations on postnatal care of the mother and newborn. https://www.who.int/publications/i/item/9789241506649 Erişim Tarihi: 19.08.2024.
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 20683112Roxanne 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 35182820Öner 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 26713096Getachew 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 36625889Garcia 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 19690450Dissiz 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 38518689Dağoğlu 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06661408
- Acronym / sponsor ID
- NewbornBathing / 185
- Conditions
- Newborn Bathing, Primiparous Pregnant Women, Anxiety, Bonding, Knowledge
- Keywords
- Newborn, Bathing, Primipar, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted in a randomized controlled experimental research design with pretest, posttest control group.
Detailed description
This study will be conducted in a randomized controlled experimental research design with pretest, posttest control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled experimental research
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Intervention group 1The 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 2 | Experimental | Behavioral: Intervention group 2In 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Can speak and understand Turkish,
- 18 years of age or older,
- Literate,
- Primiparous,
- In the third trimester of pregnancy,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention group 1The 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. | Behavioural | Intervention group 1 |
| Intervention group 2In 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. | Behavioural | Intervention group 2 |
Primary outcome
Knowledge Level of Mothers on Newborn Bathing
Time frame: average 3 months
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.
Anxiety level of women
Time frame: average 3 months
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.
Womens bonding levels
Time frame: average 3 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Results publicationWorld Health Organisation (WHO) (2013) Guidelines Approved by the Guidelines Review Committee, in WHO recommendations on postnatal care of the mother and newborn. https://www.who.int/publications/i/item/9789241506649 Erişim Tarihi: 19.08.2024.
- Results publication: PubMed 20683112Sarkar 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.
- Results publication: PubMed 35182820Roxanne 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.
- Results publicationÖner N, Le Compte A. Süreksiz Durumluk/Sürekli Kaygı Envanteri El Kitabı. s: 1-26, 1. Basım Boğaziçi Üniversitesi Yayınları, İstanbul, 1983.
- Results publicationKeten Edis E. Sağlık & Bilim 2022: Hemşirelik- IV. s. 95-103, 1. Basım, Efe Akademik Yayıncılık, İstanbul, 2022.
- Results publication: PubMed 26713096Kayom 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.
- Results publication: PubMed 36625889Getachew 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.
- Results publication: PubMed 19690450Garcia 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.
- Results publication: PubMed 38518689Dissiz 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.
- Results publicationDağoğlu T, Ovalı F. Yenidoğanın cilt bakımı. Neonatoloji. s.167-74, 2. Basım, Nobel Tıp Kitabevleri, İstanbul, 2007.
- Results publicationÇalışır H, Güler F. Riskli Yenidoğanların cilt bakımında kanıta dayalı uygulamalar. Türkiye Klinikleri Hemşirelik Bilimleri Dergisi 2011; 3(2).
- Results publicationBrockington 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.
- Individual participant dataSharing planned: No
Related trials for Newborn Bathing
Not yet recruiting
Effectiveness of GEMPO E-Education on Fathers' Self-Efficacy and Ability in Newborn Care
Fathers' Self-Efficacy and Ability in Newborn Care
Recruiting
Non-Pharmacological Methods in Heel Lance
Heel Lance Procedures
Not yet recruiting
THE EFFECT OF BATHING METHODS APPLIED TO NEWBORNS ON VITAL SIGNS
Healthy Newborns
Not yet recruiting
The Effect of Lullaby During Bath Time on Mother-Infant Bonding, Postpartum Depression, and Parental Self-Efficacy in Infants
Newborn Infant, Bonding
Recruiting
Test of Aquatic Mobility of SMA Infants
Infantile Spinal Muscular Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group 1 and Intervention group 2 in people with Newborn Bathing and Primiparous Pregnant Women, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge Level of Mothers on Newborn Bathing (time frame: average 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06661408, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.