NewbornNCT06166485
The Effect of Bath Applied in Two Different Sequences on Stress Level and Physiological Parameters in Term Babies
A study testing take a bath in people with Newborn, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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)… Read more about this study
- Who is it for?
- Ages 37 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Newborn
- What is being tested?
- take a bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jul 2023to 21 Sep 2023
- 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 37 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Newborn
- Being tested
- take a bath
- Keywords
- baby health, stress, newborn bath, newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
take a bathOther
The effects of two different bathtub bath methods on physiological parameters will be compared in babies divided into 2 different groups.
| Study group | Role | What they receive |
|---|---|---|
| 1st group babies where the head is washed first and then the whole body | Active comparator | The effects of washing the head first and then the whole body on the physiological parameters (oxygen level, pulse, body temperature, calming time, stress level) of the first group babies will be examined. Receives: Other: take a bath |
| 2nd group babies, where the whole body is washed first and the head is washed last. | Active comparator | The effects on the physiological parameters (oxygen level, pulse, body temperature, calming time, stress level) of the second group of babies, where the whole body is washed first and the head last, will be examined. Receives: Other: take a bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn stress scale
This scale can evaluate the stress level in newborns.Scale items are grouped into 8 subgroups.These subgroups consist of a total of 24 items in a 3-point Likert type, including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture.In scoring, each subgroup is evaluated between 0-2 points. A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the baby's stress level increases.
Measured: 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.
Data collection form
The form consists of 4 sections and 36 questions in total. The first part of the form is a 7-question form to collect demographic and obstetric information of mothers who agreed to participate in the study. The second part is a 9-question form in which information about the baby to be included in the study is collected. In the third section, it is a form with 15 questions in which information about the application is collected. In the fourth section, it is a form with 5 questions in which information regarding the evaluation of the baby with the stress scale is collected.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start18 Jul 2023
- Primary completion20 Sep 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for NewbornStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Dilan Koçak, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166485
- Sponsor's protocol ID
- IstanbulUCEdu
- Status last verified
- Dec 2023
- First submitted
- 3 Oct 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34953663Kusari 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.
PubMed 30548578Fernandez 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.
PubMed 29779763Moser 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.
PubMed 37193613Ar 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.
PubMed 30507829Tasdemir 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.
PubMed 31442786Kocak AD, Inal S. The effect of bath applied in two different sequences on stress level and physiological parameters in term babies. J Pediatr Nurs. 2026 Mar-Apr;87:50-57. doi: 10.1016/j.pedn.2025.12.025. Epub 2026 Jan 7.
PubMed 41505829
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bath Applied in Two Different Sequences on Stress Level and Physiological Parameters in Term Babies
- ClinicalTrials.gov ID
- NCT06166485
- Acronym / sponsor ID
- IstanbulUCEdu
- Conditions
- Newborn
- Keywords
- baby health, stress, newborn bath, newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 12 Dec 2023 (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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1st group babies where the head is washed first and then the whole body | Active comparator | Other: take a bathThe effects of washing the head first and then the whole body on the physiological parameters (oxygen level, pulse, body temperature, calming time, stress level) of the first group babies will be examined. |
| 2nd group babies, where the whole body is washed first and the head is washed last. | Active comparator | Other: take a bathThe effects on the physiological parameters (oxygen level, pulse, body temperature, calming time, stress level) of the second group of babies, where the whole body is washed first and the head last, will be examined. |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| take a bathThe effects of two different bathtub bath methods on physiological parameters will be compared in babies divided into 2 different groups. | Other | 1st group babies where the head is washed first and then the whole body, 2nd group babies, where the whole body is washed first and the head is washed last. |
Primary outcome
Newborn stress scale
Time frame: 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.
This scale can evaluate the stress level in newborns.Scale items are grouped into 8 subgroups.These subgroups consist of a total of 24 items in a 3-point Likert type, including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture.In scoring, each subgroup is evaluated between 0-2 points. A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the baby's stress level increases.
Data collection form
Time frame: 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.
The form consists of 4 sections and 36 questions in total. The first part of the form is a 7-question form to collect demographic and obstetric information of mothers who agreed to participate in the study. The second part is a 9-question form in which information about the baby to be included in the study is collected. In the third section, it is a form with 15 questions in which information about the application is collected. In the fourth section, it is a form with 5 questions in which information regarding the evaluation of the baby with the stress scale is collected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 34953663Huang 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.
- Background: PubMed 30548578Kusari 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.
- Background: PubMed 29779763Fernandez 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.
- Background: PubMed 37193613Moser 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.
- Background: PubMed 30507829Ar 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.
- Background: PubMed 31442786Tasdemir 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.
- Derived from this study: PubMed 41505829Kocak AD, Inal S. The effect of bath applied in two different sequences on stress level and physiological parameters in term babies. J Pediatr Nurs. 2026 Mar-Apr;87:50-57. doi: 10.1016/j.pedn.2025.12.025. Epub 2026 Jan 7.
- Individual participant dataSharing planned: No
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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 take a bath in people with Newborn, run by Istanbul University - Cerrahpasa 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 3 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Newborn stress scale (time frame: 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.). The study lists 2 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 NCT06166485, which also lists 7 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 3 Jan 2024.