Infant BehaviorNCT07109908
Stress Level, Skin Moisture and Physiological Parameters in the First Bath of Newborns
A study testing Wiping Bath, Wrapping Bath and Showering Bath in people with Infant Behavior, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Objectıve: The aim of this study was to determine the effect of wipe (WG), shower (SG) and tub bath (TG) on stress level, skin moisture and physiological parameters used during the first bath in newborns hospitalized in the Neonatal Intensive Care Unit (NICU). Read more about this study
- Who is it for?
- Ages 1 month to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Behavior
- What is being tested?
- Wiping Bath, Wrapping Bath and Showering Bath
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Nov 2024
- 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 1 month to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Birth weight of 2500 g or more
- Body temperature within the normal range (36-37.3°C)
- Respiratory rate between 30-60 breaths per minute
- Oxygen saturation above 85%
- Absence of neurological problems (e.g., hypotonia, hypertonia)
- Absence of congenital defects
- No dermatological problems
- Parental consent and voluntary participation in the research
Who cannot join
- Presence of respiratory failure or distress
- Requirement for ventilator support
- Continuous need for high-concentration oxygen via methods such as hood or CPAP
- History of convulsions
- Clinical evidence of infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Wiping, Showering and Wrapping Bath Used During the First Bath on Stress Level, Skin Moisture and Physiological Parameters in Neonates Hospitalized in the Neonatal Intensive Care Unit
Objectıve: The aim of this study was to determine the effect of wipe (WG), shower (SG) and tub bath (TG) on stress level, skin moisture and physiological parameters used during the first bath in newborns hospitalized in the Neonatal Intensive Care Unit (NICU).
Hypotheses of the Research
Read more
Hypothesis 01,2,3: There is no difference between wiping baths, wrapping baths and shower baths in terms of their effects on thermoregulation, stress level, skin moisture and physiological parameters of newborns.
Hypothesis 11: Newborns who are given a wrap-up bath have a lower stress level than if they are swept and showered.
Hypothesis 12: Newborns who are given a wrap-up bath have better skin moisture levels than newborns who are wiped and showered.
Hypothesis 13: Physiological parameters (body temperature, heart peak, respiratory rate, oxygen saturation) of newborns who are given a wrap bath are less affected than wiping and showering.
Read the detailed description
Bathing in newborns is an important midwifery/nursing practice that not only cleans the baby's skin, but also relaxes the baby (Tambunan and Mediani, 2019; da Fonseca Filho et al., 2017), supports immune system development (Burdall et al., 2019), and contributes to the preservation of skin integrity (Lima et al., 2020). If the appropriate method is not chosen in bathing in newborns and the bath is not performed under appropriate conditions, it may adversely affect the adaptation of the newborn to the extrauterine environment, physiological parameters and stress level. Therefore; the bath should be applied in a warm environment, in a safe and peaceful way, and with the appropriate method (Lima et al., 2020). In addition to performing bathing in the appropriate way, midwives/nurses should take appropriate precautions by observing the physiological parameters and stress responses of infants (Huang et al., 2022; Tambunan et al., 2022).
In newborns, wrap-around bath, wipe bath and shower bath methods are frequently used. Wiping bath is the process of wiping the baby's skin. The wrap-around bathtub bath method is to clean the baby by wrapping it with a soft towel or blanket and placing it in a bathtub filled with water at the appropriate temperature, preserving the flexion and midline position. A bath in the form of a shower is the process of bathing the newborn under running water (Ceylan and Bolışık, 2022; Karakul and Dogan, 2020).
- Conditions
- Infant Behavior
- Being tested
- Wiping Bath, Wrapping Bath, Showering Bath
- Medical subject headings
- Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wiping BathBehavioural
The babies in this group were given the first bath in the form of wiping baths. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns.
The newborn's clothes except the diaper are removed, the newborn is wrapped in a towel, the newborn's face and body are wiped clean with a skin cleanser and cotton cloth compatible with the baby's skin, the diaper is removed and the genital area is wiped, the baby's body is wiped with a cloth moistened with water (37-39 oc), the body is dried, the baby's body is wrapped in a dry towel, the baby's head is washed with a shampoo compatible with the baby's skin, the baby's head is dried and a hat is put on, The newborn was dressed in clothes.
Wrapping BathBehavioural
The first bath of the babies in this group was in the form of a wrap-up bath, in which the baby was wrapped and placed in the bathtub. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns.
The newborn's clothes were removed, the newborn was wrapped in a towel, the newborn was slowly immersed in water wrapped in a towel in a bathtub with a maximum of 7 cm of water at the appropriate temperature (37-39 oC), the towel was gently opened and the baby's body was gently cleaned with a suitable cleansing product and a cotton swab, including the torso, legs and genital area, the baby's head was wetted and washed with a shampoo compatible with the baby's skin, the baby's head was rinsed by pouring water from the hairline, The baby's torso was gently removed from the bathtub and rinsed, the newborn baby was dried and then dressed in clothes.
Showering BathBehavioural
The first bath of the babies in this group was in the form of a shower bath. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns.
The newborn's clothes are removed, the newborn's body is soaked with water at the appropriate temperature (37-39 oC) under running water, the body is washed with the appropriate skin cleanser and cotton cloth, the head is washed with the appropriate shampoo for the baby's skin, the whole body is rinsed under running water, the whole body is dried with a towel and the clothes are dressed.
| Study group | Role | What they receive |
|---|---|---|
| Wiping Bath | Experimental | The babies in this group were given the first bath in the form of wiping baths. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns.
The newborn's clothes except the diaper are removed, the newborn is wrapped in a towel, the newborn's face and body are wiped clean with a skin cleanser and cotton cloth compatible with the baby's skin, the diaper is removed and the genital area is wiped, the baby's body is wiped with a cloth moistened with water (37-39 oc), the body is dried, the baby's body is wrapped in a dry towel, the baby's head is washed with a shampoo compatible with the baby's skin, the baby's head is dried and a hat is put on, The newborn was dressed in clothes. Receives: Behavioral: Wiping Bath |
| Wrapping Bath | Experimental | The first bath of the babies in this group was in the form of a wrap-up bath, in which the baby was wrapped and placed in the bathtub. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns.
The newborn's clothes were removed, the newborn was wrapped in a towel, the newborn was slowly immersed in water wrapped in a towel in a bathtub with a maximum of 7 cm of water at the appropriate temperature (37-39 oC), the towel was gently opened and the baby's body was gently cleaned with a suitable cleansing product and a cotton swab, including the torso, legs and genital area, the baby's head was wetted and washed with a shampoo compatible with the baby's skin, the baby's head was rinsed by pouring water from the hairline, The baby's torso was gently removed from the bathtub and rinsed, the newborn baby was dried and then dressed in clothes. Receives: Behavioral: Wrapping Bath |
| Showering Bath | Experimental | The first bath of the babies in this group was in the form of a shower bath. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns.
The newborn's clothes are removed, the newborn's body is soaked with water at the appropriate temperature (37-39 oC) under running water, the body is washed with the appropriate skin cleanser and cotton cloth, the head is washed with the appropriate shampoo for the baby's skin, the whole body is rinsed under running water, the whole body is dried with a towel and the clothes are dressed. Receives: Behavioral: Showering Bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological Variables Follow-up Form
Developed by researchers based on the literature (Taşdemir, 2017; Tibik and Şener, 2024) this form, physiological variables of the newborn; heart rate (min), respiratory rate (min), oxygen saturation value (%SpO2%), body temperature (°C) and neonatal skin condition score were used to record the evaluation results. The physiological parameters of the newborn were evaluated three times in each group: just before, immediately after bathing and 30 minutes after bathing.
Measured: Just before bathing, just after bathing, and 30 minutes after bathing
Skin Moisture Tracking Form
Developed by researchers based on the literature (Çeçen, 2023; Taşdemir and Efe, 2025). Skin moisture monitoring was measured with a skin moisture meter and recorded in the form. Skin moisture measurement was made by the same nurse from the determined areas (forehead, abdomen, forearm and upper leg) just before the bath and at the 6th, 12th hour and 24th hour after the bath. The Skin Moisture Meter is used to measure the amount of moisture at any point of the body only by contact with the skin, with its precise measurement feature. The humidity measurement of the device is in the range of 0% - 99.9%. The moisture meter weighs 40° and works effectively at ambient temperatures between 5° and 40° C (Konar et al., 2020).
Measured: 6th hour, 12th hour and 24th hour just before and after bath
Neonatal Stress Scale
The neonatal stress scale was developed by Ceylan and Bolışık (2017) to assess the stress level in premature babies. The scale includes 8 subgroups including facial expression, body color, respiration, activity level, consolation, muscle tone, extremities and posture and consists of a total of 24 items in 3-point Likert type. In scoring, each subgroup is evaluated between 0-2 points. The score obtained from the scale is a minimum of 0 points and a maximum of 16 points. An increase in the score indicates that the baby's stress level has increased. Cronbach's Alpha values of the scale ranged from 0.65 to 0.81 for Observer 1 and 0.69 to 0.78 for Observer 2 (Ceylan and Bolışık 2017). The stress level of the newborns was evaluated 5 times through the Neonatal Stress Scale, 10 minutes before bathing, during the bath, immediately after the bath, 15 minutes after the bath, and 30 minutes after the bath.
Measured: 10 min before bathing, during bathing, just after bathing, 15 and 30 min after bathing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Jan 2024
- Primary completion30 Jan 2024
- Study completion30 Nov 2024
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 Infant BehaviorStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Guney, Istanbul University - Cerrahpasa
- Investigators
- demet güney, MSc., Principal investigator, https://sbf.kastamonu.edu.tr/index.php/boeluemler/ebelik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109908
- Sponsor's protocol ID
- Kastamonu Unıversity
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burdall O, Willgress L, Goad N. Neonatal skin care: Developments in care to maintain neonatal barrier function and prevention of diaper dermatitis. Pediatr Dermatol. 2019 Jan;36(1):31-35. doi: 10.1111/pde.13714. Epub 2018 Dec 2.
PubMed 30506880Cinar N, Yalnizoglu Caka S, Uslu Yuvaci H. Effect of newborn bathing training with the swaddled and tub bathing methods given to primiparous pregnant women on the mother's experience, satisfaction and newborn's stress during the first bathing of the newborn at home: A mixed method study. Jpn J Nurs Sci. 2020 Oct;17(4):e12363. doi: 10.1111/jjns.12363. Epub 2020 Aug 25.
PubMed 32844590de Freitas P, Bueno M, Holditch-Davis D, Santos HP, Kimura AF. Biobehavioral Responses of Preterm Infants to Conventional and Swaddled Tub Baths: A Randomized Crossover Trial. J Perinat Neonatal Nurs. 2018 Oct/Dec;32(4):358-365. doi: 10.1097/JPN.0000000000000336.
PubMed 29782435Edraki M, Paran M, Montaseri S, Razavi Nejad M, Montaseri Z. Comparing the effects of swaddled and conventional bathing methods on body temperature and crying duration in premature infants: a randomized clinical trial. J Caring Sci. 2014 Jun 1;3(2):83-91. doi: 10.5681/jcs.2014.009. eCollection 2014 Jun.
PubMed 25276751Fernandez 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 29779763Higuchi S, Yoshida S, Minematsu T, Hatano Y, Notsu A, Ichinose T. Comparison of the Effects of Bathing and the Dry Technique on the Skin Condition of Early Neonates: A Prospective Observational Study. Ann Dermatol. 2023 Aug;35(4):256-265. doi: 10.5021/ad.22.098.
PubMed 37550226Konar MC, Islam K, Roy A, Ghosh T. Effect of Virgin Coconut Oil Application on the Skin of Preterm Newborns: A Randomized Controlled Trial. J Trop Pediatr. 2020 Apr 1;66(2):129-135. doi: 10.1093/tropej/fmz041.
PubMed 31257430
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Wiping, Showering and Wrapping Bath Used During the First Bath on Stress Level, Skin Moisture and Physiological Parameters in Neonates Hospitalized in the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07109908
- Acronym / sponsor ID
- Kastamonu Unıversity
- Conditions
- Infant Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 7 Aug 2025 (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.
Objectıve: The aim of this study was to determine the effect of wipe (WG), shower (SG) and tub bath (TG) on stress level, skin moisture and physiological parameters used during the first bath in newborns hospitalized in the Neonatal Intensive Care Unit (NICU).
Hypotheses of the Research
Hypothesis 01,2,3: There is no difference between wiping baths, wrapping baths and shower baths in terms of their effects on thermoregulation, stress level, skin moisture and physiological parameters of newborns.
Hypothesis 11: Newborns who are given a wrap-up bath have a lower stress level than if they are swept and showered.
Hypothesis 12: Newborns who are given a wrap-up bath have better skin moisture levels than newborns who are wiped and showered.
Hypothesis 13: Physiological parameters (body temperature, heart peak, respiratory rate, oxygen saturation) of newborns who are given a wrap bath are less affected than wiping and showering.
Detailed description
Bathing in newborns is an important midwifery/nursing practice that not only cleans the baby's skin, but also relaxes the baby (Tambunan and Mediani, 2019; da Fonseca Filho et al., 2017), supports immune system development (Burdall et al., 2019), and contributes to the preservation of skin integrity (Lima et al., 2020). If the appropriate method is not chosen in bathing in newborns and the bath is not performed under appropriate conditions, it may adversely affect the adaptation of the newborn to the extrauterine environment, physiological parameters and stress level. Therefore; the bath should be applied in a warm environment, in a safe and peaceful way, and with the appropriate method (Lima et al., 2020). In addition to performing bathing in the appropriate way, midwives/nurses should take appropriate precautions by observing the physiological parameters and stress responses of infants (Huang et al., 2022; Tambunan et al., 2022).
In newborns, wrap-around bath, wipe bath and shower bath methods are frequently used. Wiping bath is the process of wiping the baby's skin. The wrap-around bathtub bath method is to clean the baby by wrapping it with a soft towel or blanket and placing it in a bathtub filled with water at the appropriate temperature, preserving the flexion and midline position. A bath in the form of a shower is the process of bathing the newborn under running water (Ceylan and Bolışık, 2022; Karakul and Dogan, 2020).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wiping Bath | Experimental | Behavioral: Wiping BathThe babies in this group were given the first bath in the form of wiping baths. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns. The newborn's clothes except the diaper are removed, the newborn is wrapped in a towel, the newborn's face and body are wiped clean with a skin cleanser and cotton cloth compatible with the baby's skin, the diaper is removed and the genital area is wiped, the baby's body is wiped with a cloth moistened with water (37-39 oc), the body is dried, the baby's body is wrapped in a dry towel, the baby's head is washed with a shampoo compatible with the baby's skin, the baby's head is dried and a hat is put on, The newborn was dressed in clothes. |
| Wrapping Bath | Experimental | Behavioral: Wrapping BathThe first bath of the babies in this group was in the form of a wrap-up bath, in which the baby was wrapped and placed in the bathtub. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns. The newborn's clothes were removed, the newborn was wrapped in a towel, the newborn was slowly immersed in water wrapped in a towel in a bathtub with a maximum of 7 cm of water at the appropriate temperature (37-39 oC), the towel was gently opened and the baby's body was gently cleaned with a suitable cleansing product and a cotton swab, including the torso, legs and genital area, the baby's head was wetted and washed with a shampoo compatible with the baby's skin, the baby's head was rinsed by pouring water from the hairline, The baby's torso was gently removed from the bathtub and rinsed, the newborn baby was dried and then dressed in clothes. |
| Showering Bath | Experimental | Behavioral: Showering BathThe first bath of the babies in this group was in the form of a shower bath. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns. The newborn's clothes are removed, the newborn's body is soaked with water at the appropriate temperature (37-39 oC) under running water, the body is washed with the appropriate skin cleanser and cotton cloth, the head is washed with the appropriate shampoo for the baby's skin, the whole body is rinsed under running water, the whole body is dried with a towel and the clothes are dressed. |
Who may qualify
- Ages
- 1 month to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Birth weight of 2500 g or more
- Body temperature within the normal range (36-37.3°C)
- Respiratory rate between 30-60 breaths per minute
- Oxygen saturation above 85%
- Absence of neurological problems (e.g., hypotonia, hypertonia)
Key exclusion criteria (5 listed)
- Presence of respiratory failure or distress
- Requirement for ventilator support
- Continuous need for high-concentration oxygen via methods such as hood or CPAP
- History of convulsions
- Clinical evidence of infection
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 |
|---|---|---|
| Wiping BathThe babies in this group were given the first bath in the form of wiping baths. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns. The newborn's clothes except the diaper are removed, the newborn is wrapped in a towel, the newborn's face and body are wiped clean with a skin cleanser and cotton cloth compatible with the baby's skin, the diaper is removed and the genital area is wiped, the baby's body is wiped with a cloth moistened with water (37-39 oc), the body is dried, the baby's body is wrapped in a dry towel, the baby's head is washed with a shampoo compatible with the baby's skin, the baby's head is dried and a hat is put on, The newborn was dressed in clothes. | Behavioural | Wiping Bath |
| Wrapping BathThe first bath of the babies in this group was in the form of a wrap-up bath, in which the baby was wrapped and placed in the bathtub. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns. The newborn's clothes were removed, the newborn was wrapped in a towel, the newborn was slowly immersed in water wrapped in a towel in a bathtub with a maximum of 7 cm of water at the appropriate temperature (37-39 oC), the towel was gently opened and the baby's body was gently cleaned with a suitable cleansing product and a cotton swab, including the torso, legs and genital area, the baby's head was wetted and washed with a shampoo compatible with the baby's skin, the baby's head was rinsed by pouring water from the hairline, The baby's torso was gently removed from the bathtub and rinsed, the newborn baby was dried and then dressed in clothes. | Behavioural | Wrapping Bath |
| Showering BathThe first bath of the babies in this group was in the form of a shower bath. The bathing application was carried out by the midwife working in the unit and experienced in bathing newborns. The newborn's clothes are removed, the newborn's body is soaked with water at the appropriate temperature (37-39 oC) under running water, the body is washed with the appropriate skin cleanser and cotton cloth, the head is washed with the appropriate shampoo for the baby's skin, the whole body is rinsed under running water, the whole body is dried with a towel and the clothes are dressed. | Behavioural | Showering Bath |
Primary outcome
Physiological Variables Follow-up Form
Time frame: Just before bathing, just after bathing, and 30 minutes after bathing
Developed by researchers based on the literature (Taşdemir, 2017; Tibik and Şener, 2024) this form, physiological variables of the newborn; heart rate (min), respiratory rate (min), oxygen saturation value (%SpO2%), body temperature (°C) and neonatal skin condition score were used to record the evaluation results. The physiological parameters of the newborn were evaluated three times in each group: just before, immediately after bathing and 30 minutes after bathing.
Skin Moisture Tracking Form
Time frame: 6th hour, 12th hour and 24th hour just before and after bath
Developed by researchers based on the literature (Çeçen, 2023; Taşdemir and Efe, 2025). Skin moisture monitoring was measured with a skin moisture meter and recorded in the form. Skin moisture measurement was made by the same nurse from the determined areas (forehead, abdomen, forearm and upper leg) just before the bath and at the 6th, 12th hour and 24th hour after the bath. The Skin Moisture Meter is used to measure the amount of moisture at any point of the body only by contact with the skin, with its precise measurement feature. The humidity measurement of the device is in the range of 0% - 99.9%. The moisture meter weighs 40° and works effectively at ambient temperatures between 5° and 40° C (Konar et al., 2020).
Neonatal Stress Scale
Time frame: 10 min before bathing, during bathing, just after bathing, 15 and 30 min after bathing
The neonatal stress scale was developed by Ceylan and Bolışık (2017) to assess the stress level in premature babies. The scale includes 8 subgroups including facial expression, body color, respiration, activity level, consolation, muscle tone, extremities and posture and consists of a total of 24 items in 3-point Likert type. In scoring, each subgroup is evaluated between 0-2 points. The score obtained from the scale is a minimum of 0 points and a maximum of 16 points. An increase in the score indicates that the baby's stress level has increased. Cronbach's Alpha values of the scale ranged from 0.65 to 0.81 for Observer 1 and 0.69 to 0.78 for Observer 2 (Ceylan and Bolışık 2017). The stress level of the newborns was evaluated 5 times through the Neonatal Stress Scale, 10 minutes before bathing, during the bath, immediately after the bath, 15 minutes after the bath, and 30 minutes after the bath.
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 7 Aug 2025.
- Background: PubMed 30506880Burdall O, Willgress L, Goad N. Neonatal skin care: Developments in care to maintain neonatal barrier function and prevention of diaper dermatitis. Pediatr Dermatol. 2019 Jan;36(1):31-35. doi: 10.1111/pde.13714. Epub 2018 Dec 2.
- Background: PubMed 32844590Cinar N, Yalnizoglu Caka S, Uslu Yuvaci H. Effect of newborn bathing training with the swaddled and tub bathing methods given to primiparous pregnant women on the mother's experience, satisfaction and newborn's stress during the first bathing of the newborn at home: A mixed method study. Jpn J Nurs Sci. 2020 Oct;17(4):e12363. doi: 10.1111/jjns.12363. Epub 2020 Aug 25.
- Background: PubMed 29782435de Freitas P, Bueno M, Holditch-Davis D, Santos HP, Kimura AF. Biobehavioral Responses of Preterm Infants to Conventional and Swaddled Tub Baths: A Randomized Crossover Trial. J Perinat Neonatal Nurs. 2018 Oct/Dec;32(4):358-365. doi: 10.1097/JPN.0000000000000336.
- Background: PubMed 25276751Edraki M, Paran M, Montaseri S, Razavi Nejad M, Montaseri Z. Comparing the effects of swaddled and conventional bathing methods on body temperature and crying duration in premature infants: a randomized clinical trial. J Caring Sci. 2014 Jun 1;3(2):83-91. doi: 10.5681/jcs.2014.009. eCollection 2014 Jun.
- 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 37550226Higuchi S, Yoshida S, Minematsu T, Hatano Y, Notsu A, Ichinose T. Comparison of the Effects of Bathing and the Dry Technique on the Skin Condition of Early Neonates: A Prospective Observational Study. Ann Dermatol. 2023 Aug;35(4):256-265. doi: 10.5021/ad.22.098.
- Background: PubMed 31257430Konar MC, Islam K, Roy A, Ghosh T. Effect of Virgin Coconut Oil Application on the Skin of Preterm Newborns: A Randomized Controlled Trial. J Trop Pediatr. 2020 Apr 1;66(2):129-135. doi: 10.1093/tropej/fmz041.
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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.
demet güney, MSc. principal investigator
https://sbf.kastamonu.edu.tr/index.php/boeluemler/ebelik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wiping Bath, Wrapping Bath and Showering Bath in people with Infant Behavior, 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 8 inclusion and 5 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 7 Aug 2025. 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?
Physiological Variables Follow-up Form (time frame: Just before bathing, just after bathing, and 30 minutes after bathing). 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 NCT07109908, 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 7 Aug 2025.