Neonatal Care Neonatal Comfort Swaddled Bathing Wipe BathingWS-Bath RCTNCT06887686
The Effect of Wiping and Swaddling Bath Methods Applied in the Neonatal Intensive Care Unit on Neonatal Comfort: a Randomized Controlled Trial
A study testing Swaddled Bath Intervention Wipe Bath Intervention in people with Neonatal Care Neonatal Comfort Swaddled Bathing Wipe Bathing, run by Gamze Gocmen at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted as a randomized controlled trial to examine the effects of different bathing methods on neonatal comfort. The study will take place in the Neonatal Intensive Care Unit (NICU) of İzmir Tepecik Training and Research Hospital, with a total sample size of 64 neonates who meet the inclusion… Read more about this study
- Who is it for?
- Ages 2 to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Care Neonatal Comfort Swaddled Bathing Wipe Bathing
- What is being tested?
- Swaddled Bath Intervention Wipe Bath Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2024to 3 Mar 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 2 to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born at 37 weeks of gestation or later
- Aged between 2 and 7 days
- Born after 24 hours
- Stable physiological parameters
- Spontaneous respiration
- Birth weight ≥ 2000 grams
- No skin problems that would prevent the administration of swaddle or wipe bath
- Both vaginal and cesarean deliveries are accepted
Who cannot join
- Using sedative or muscle relaxant medications
- Previously exposed to any bath method
- On mechanical ventilation
- Diagnosed with sepsis
- Within the first 78 hours post-operatively
- Having a central catheter
Show all 9Show fewer
- Having disrupted skin integrity
- Having cranial hemorrhage
- Major congenital, chromosomal, or neurological anomalies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Tepecik Training and Research Hospital
Izmir
About this study
Official title: This Study Complies with the Requirements of the Final Rule (42 CFR Part 11) for Clinical Trials with a Start Date of January 18, 2017, or Later, Including the Registration and Reporting of Results As Per the Applicable Regulations.
This study will be conducted as a randomized controlled trial to examine the effects of different bathing methods on neonatal comfort. The study will take place in the Neonatal Intensive Care Unit (NICU) of İzmir Tepecik Training and Research Hospital, with a total sample size of 64 neonates who meet the inclusion criteria.
Neonates born at 37 weeks or later, with stable physiological parameters, and receiving their first bath will be included. Those diagnosed with sepsis, on mechanical ventilation, or with impaired skin integrity will be excluded.
The swaddled bath will be applied to the intervention group, while the wipe bath will be applied to the control group. Neonatal comfort levels will be assessed by a second nurse at 10 and 60 minutes after bathing. Data collection will utilize the COMFORT Neo scale, and statistical analyses will be performed using IBM SPSS. T-tests, ANOVA, and correlation tests will be used to compare the effects of bathing methods on neonatal comfort.
Read the detailed description
This study is designed as a randomized controlled trial to compare the effects of swaddled bathing and wipe bathing on neonatal comfort in Neonatal Intensive Care Units (NICUs). The study will be conducted in the NICU of İzmir Tepecik Training and Research Hospital, and after obtaining ethical approval, 64 neonates meeting the inclusion criteria will be enrolled.
As part of the study, the swaddled bath will be applied to the intervention group, while the wipe bath will be applied to the control group. The bathing procedures will be carried out by the researcher according to standard protocols. Neonatal comfort levels will be assessed by a second nurse working in the NICU at 10 and 60 minutes after bathing, using the COMFORT Neo scale.
Data Analysis:
Collected data will be analyzed using IBM SPSS Statistical Package Program. Descriptive statistics (mean, percentage, standard deviation) will be calculated, and t-tests, ANOVA, and correlation analysis will be conducted to evaluate differences between the groups.
Ethical Considerations:
Prior to the study, approval will be obtained from the Non-Interventional Research Ethics Committee of İzmir Tepecik Training and Research Hospital. Additionally, parents of the neonates will be provided with detailed information about the study, and informed consent will be obtained.
This study aims to contribute to the standardization of bathing methods in NICUs and to determine the most effective technique for improving neonatal comfort.
- Being tested
- Swaddled Bath Intervention Wipe Bath Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swaddled Bath Intervention Wipe Bath InterventionBehavioural
Swaddled Bath Intervention:
In the swaddled bath group, infants are gently wrapped in a soft towel or blanket to maintain a flexed position. They are then immersed in warm water at an appropriate temperature to regulate body temperature. This intervention is designed to reduce stress and pain, particularly for premature infants, and helps to relax the baby's muscles, stabilize body temperature, and increase overall comfort. It is expected to show a more significant effect on physiological and behavioral stabilization than less invasive methods.
Wipe Bath Intervention:
In the wipe bath group, infants are gently wiped with a cloth soaked in warm water. This method is less invasive than the swaddled bath, aiming to maintain body temperature while providing a milder level of relaxation. The wipe bath is effective for skin cleansing but may not provide the same comfort or stress-reducing effects as the swaddled bath. The expected physiological effects, such as body temperature stabilizatio
| Study group | Role | What they receive |
|---|---|---|
| Swaddled Bath Group Wipe Bath Group | Experimental | Swaddled Bath Group:
In this group, infants are wrapped in a soft towel or blanket to maintain a flexed position and then immersed in warm water at an appropriate temperature. The swaddled bath is designed to reduce stress and pain, especially for premature infants. It promotes relaxation, stabilizes the body temperature, and enhances the infant's comfort by reducing crying. The wrapping creates a secure and calming environment that mimics the comforting sensations of the womb, helping to soothe the infant's physiological and behavioral responses.
Wipe Bath Group:
In this group, infants are gently wiped with a cloth soaked in warm water. The wipe bath helps maintain body temperature, but it is less invasive than the swaddled bath and does not have the same calming effects. This method is primarily used for cleaning the baby's skin, while not providing as much relaxation or physiological stabilization as the swaddled bath. Although effective for hygiene purposes, it has a milder imp Receives: Behavioral: Swaddled Bath Intervention Wipe Bath Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn comfort (measured with the KONFOR Neo scale)
Measured: Data collection will include comfort assessments at the 10th and 60th minutes after the bath.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start4 Mar 2024
- Primary completion4 Sep 2024
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Care Neonatal Comfort Swaddled Bathing Wipe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gamze Gocmen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gamze Gocmen, Ege University
- Investigators
- Aysun Ekşioğlu, Doç. Dr., Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887686
- Sponsor's protocol ID
- 2024/01-19
- Acronym
- WS-Bath RCT
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Study Complies with the Requirements of the Final Rule (42 CFR Part 11) for Clinical Trials with a Start Date of January 18, 2017, or Later, Including the Registration and Reporting of Results As Per the Applicable Regulations.
- ClinicalTrials.gov ID
- NCT06887686
- Acronym / sponsor ID
- WS-Bath RCT / 2024/01-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Gamze GocmenUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 20 Mar 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.
This study will be conducted as a randomized controlled trial to examine the effects of different bathing methods on neonatal comfort. The study will take place in the Neonatal Intensive Care Unit (NICU) of İzmir Tepecik Training and Research Hospital, with a total sample size of 64 neonates who meet the inclusion criteria.
Neonates born at 37 weeks or later, with stable physiological parameters, and receiving their first bath will be included. Those diagnosed with sepsis, on mechanical ventilation, or with impaired skin integrity will be excluded.
The swaddled bath will be applied to the intervention group, while the wipe bath will be applied to the control group. Neonatal comfort levels will be assessed by a second nurse at 10 and 60 minutes after bathing. Data collection will utilize the COMFORT Neo scale, and statistical analyses will be performed using IBM SPSS. T-tests, ANOVA, and correlation tests will be used to compare the effects of bathing methods on neonatal comfort.
Detailed description
This study is designed as a randomized controlled trial to compare the effects of swaddled bathing and wipe bathing on neonatal comfort in Neonatal Intensive Care Units (NICUs). The study will be conducted in the NICU of İzmir Tepecik Training and Research Hospital, and after obtaining ethical approval, 64 neonates meeting the inclusion criteria will be enrolled.
As part of the study, the swaddled bath will be applied to the intervention group, while the wipe bath will be applied to the control group. The bathing procedures will be carried out by the researcher according to standard protocols. Neonatal comfort levels will be assessed by a second nurse working in the NICU at 10 and 60 minutes after bathing, using the COMFORT Neo scale.
Data Analysis:
Collected data will be analyzed using IBM SPSS Statistical Package Program. Descriptive statistics (mean, percentage, standard deviation) will be calculated, and t-tests, ANOVA, and correlation analysis will be conducted to evaluate differences between the groups.
Ethical Considerations:
Prior to the study, approval will be obtained from the Non-Interventional Research Ethics Committee of İzmir Tepecik Training and Research Hospital. Additionally, parents of the neonates will be provided with detailed information about the study, and informed consent will be obtained.
This study aims to contribute to the standardization of bathing methods in NICUs and to determine the most effective technique for improving neonatal comfort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Swaddled Bath Group Wipe Bath Group | Experimental | Behavioral: Swaddled Bath Intervention Wipe Bath InterventionSwaddled Bath Group: In this group, infants are wrapped in a soft towel or blanket to maintain a flexed position and then immersed in warm water at an appropriate temperature. The swaddled bath is designed to reduce stress and pain, especially for premature infants. It promotes relaxation, stabilizes the body temperature, and enhances the infant's comfort by reducing crying. The wrapping creates a secure and calming environment that mimics the comforting sensations of the womb, helping to soothe the infant's physiological and behavioral responses. Wipe Bath Group: In this group, infants are gently wiped with a cloth soaked in warm water. The wipe bath helps maintain body temperature, but it is less invasive than the swaddled bath and does not have the same calming effects. This method is primarily used for cleaning the baby's skin, while not providing as much relaxation or physiological stabilization as the swaddled bath. Although effective for hygiene purposes, it has a milder imp |
Who may qualify
- Ages
- 2 to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Born at 37 weeks of gestation or later
- Aged between 2 and 7 days
- Born after 24 hours
- Stable physiological parameters
- Spontaneous respiration
Key exclusion criteria (9 listed)
- Using sedative or muscle relaxant medications
- Previously exposed to any bath method
- On mechanical ventilation
- Diagnosed with sepsis
- Within the first 78 hours post-operatively
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 |
|---|---|---|
| Swaddled Bath Intervention Wipe Bath InterventionSwaddled Bath Intervention: In the swaddled bath group, infants are gently wrapped in a soft towel or blanket to maintain a flexed position. They are then immersed in warm water at an appropriate temperature to regulate body temperature. This intervention is designed to reduce stress and pain, particularly for premature infants, and helps to relax the baby's muscles, stabilize body temperature, and increase overall comfort. It is expected to show a more significant effect on physiological and behavioral stabilization than less invasive methods. Wipe Bath Intervention: In the wipe bath group, infants are gently wiped with a cloth soaked in warm water. This method is less invasive than the swaddled bath, aiming to maintain body temperature while providing a milder level of relaxation. The wipe bath is effective for skin cleansing but may not provide the same comfort or stress-reducing effects as the swaddled bath. The expected physiological effects, such as body temperature stabilizatio | Behavioural | Swaddled Bath Group Wipe Bath Group |
Primary outcome
Newborn comfort (measured with the KONFOR Neo scale)
Time frame: Data collection will include comfort assessments at the 10th and 60th 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 20 Mar 2025.
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.
Aysun Ekşioğlu, Doç. Dr. principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swaddled Bath Intervention Wipe Bath Intervention in people with Neonatal Care Neonatal Comfort Swaddled Bathing Wipe Bathing, run by Gamze Gocmen 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 9 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 20 Mar 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?
Newborn comfort (measured with the KONFOR Neo scale) (time frame: Data collection will include comfort assessments at the 10th and 60th minutes after the bath.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2025.