StressNCT06171997
The Effect of Safe Swaddling After Bathing on Stress and Comfort in Newborns
A study testing Swaddling after bath group in people with Stress and Comfort, run by Funda Kardas Ozdemir at 1 site in Turkey (Türkiye).
Trial summary
The research will be conducted experimentally in the form of randomized controlled studies to determine the effect of safe swaddling of newborns after bathing on stress and comfort. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- What is being tested?
- Swaddling after bath group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 15 Feb 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 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The week of gestation is between 37 and 41 weeks,
- Birth weight being 2500 g and above,
- Having spontaneous breathing,
- Its physiological parameters are stable,
- Having completed the first 24 hours of life,
- No invasive interventions should be made before the bathing process.
Who cannot join
- Preterms with a gestational age of 22-37 weeks,
- Connected to mechanical ventilator,
- Those who have been wiped or bathed in the last 12 hours,
- Within the first 78 hours of the post-operative period,
- With central catheter,
- Diagnosed with sepsis,
- Those who use sedative and/or muscle relaxants,
- Those with congenital, chromosomal anomalies,
Trial locations and contacts
1 site in 1 country.
About this study
The research will be conducted experimentally in the form of randomized controlled studies to determine the effect of safe swaddling of newborns after bathing on stress and comfort. The population of the research consists of newborns receiving treatment and care in the Neonatal Intensive Care Unit of a State Hospital located in the north of Turkey, and the sample consists of 72 babies who meet the sample selection criteria. Descriptive Characteristics Form, Newborn Stress Scale and Newborn Comfort Behavior Scale were used to collect data. Babies will be bathed in the bathtub and then swaddled. The baby will be placed in the incubator and kept for 15 minutes. After 15 minutes, the swaddle will be opened quietly and slowly, without disturbing the body posture. Stress and comfort scores will be given by two observers by video recording the babies before bathing, before swaddling and after swaddling.
Read the detailed description
Baby bathing is a nursing intervention with individual benefits. Today, there are ongoing discussions about when the infant bath, which is an important part of skin care, should be done first. However, the World Health Organization recommends not bathing newborns for the first 24 hours and waiting until vital signs stabilized. Postponing the bathing of newborns to 48 hours after birth is both effective in maintaining the baby's body temperature and improves skin integrity. Since the thermoregulation abilities of newborns are very limited, it is necessary to maintain body temperature, provide appropriate environmental conditions and warming after bathing.
Although the bathing process, which is an important part of hospital care, protects the health of the newborn, it is also a stressful action for babies and stress symptoms are observed in these babies after bathing. Swaddling the baby in stressful situations such as bathing contributes to the baby's self-calming. The swaddling technique mimics the uterus for newborns and is a technique that ensures the continuation of the intrauterine environment.
Neonatal nursing has come to the forefront in recent years with the development of strategies that increase comfort and has become a frequently used concept in neonatal intensive care units.Among the interventions frequently applied by pediatric nurses to increase comfort are practices such as relaxing positioning, massage, bathing, and wrapping.The practices of nurses to increase the comfort level of the baby and reduce stress with practices with increased level of evidence are very important in terms of nursing care and physical and neuromotor development of the bab.In the light of all this information, this study was planned to investigate the effect of safe swaddling after bathing on stress and comfort in newborns.
- Being tested
- Swaddling after bath group
- Keywords
- Newborn, Bath, Swaddling, Stress, Comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swaddling after bath groupOther
The babies were bathed in the bathtub. Then swaddling was done. The baby was taken into the incubator and waited for 15 minutes. At the end of 15 minutes, the swaddle was opened quietly and slowly, without disturbing the body posture. Stress and comfort scores were given by two observers by video recording the babies before bathing, before swaddling and after swaddling.
Newborns' stress will be assessed with the Newborn Stress Scale and their comfort with the Newborn Comfort Behavior Scale.
| Study group | Role | What they receive |
|---|---|---|
| Swaddling after bath group | Experimental | Newborns in this group will be swaddled safely after bath. Receives: Other: Swaddling after bath group |
| No swaddling after bath group | No intervention | No action will be taken after bath. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in stress
The Newborn Stress scale will be used to evaluate stress in babies. The scale consists of 8 subgroups including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities and posture, and a total of 24 items in a 3-point Likert type. In scoring, each subgroup is evaluated between 0-2 points. The minimum score obtained from the scale is 0 points and the maximum is 16 points. An increase in the score indicates that the baby's stress level has increased. A change in stress is expected through safe swaddling after bathing compared to before bathing.
Measured: 15th minute after the procedure
change in comfort
Newborn Comfort Behavior Scale (COMFORTneo) will be used to evaluate comfort in babies. It has been stated that the lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6 and the highest score is 30. High scores indicate that the baby is not comfortable and needs interventions to provide comfort. A change in comfort is expected after bathing compared to before bathing through safe swaddling.
Measured: 15th minute after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start15 Feb 2022
- Primary completion15 Dec 2023
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- 36 baby in experimental group and 36 baby in control group, a total of 72 bany will be included in the study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Funda Kardas Ozdemir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Funda Kardas Ozdemir, Kafkas University
- Investigators
- Kübra Sevgi, RN, Principal investigator, Kafkas UniversityFunda Kardaş Özdemir, PhD, Study director, Kafkas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171997
- Sponsor's protocol ID
- Funda1
- Status last verified
- Dec 2023
- First submitted
- 24 Nov 2023
- Last updated
- 28 Jan 2026
- 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Safe Swaddling After Bathing on Stress and Comfort in Newborns
- ClinicalTrials.gov ID
- NCT06171997
- Acronym / sponsor ID
- Funda1
- Keywords
- Newborn, Bath, Swaddling, Stress, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Funda Kardas OzdemirUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 15 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.
The research will be conducted experimentally in the form of randomized controlled studies to determine the effect of safe swaddling of newborns after bathing on stress and comfort. The population of the research consists of newborns receiving treatment and care in the Neonatal Intensive Care Unit of a State Hospital located in the north of Turkey, and the sample consists of 72 babies who meet the sample selection criteria. Descriptive Characteristics Form, Newborn Stress Scale and Newborn Comfort Behavior Scale were used to collect data. Babies will be bathed in the bathtub and then swaddled. The baby will be placed in the incubator and kept for 15 minutes. After 15 minutes, the swaddle will be opened quietly and slowly, without disturbing the body posture. Stress and comfort scores will be given by two observers by video recording the babies before bathing, before swaddling and after swaddling.
Detailed description
Baby bathing is a nursing intervention with individual benefits. Today, there are ongoing discussions about when the infant bath, which is an important part of skin care, should be done first. However, the World Health Organization recommends not bathing newborns for the first 24 hours and waiting until vital signs stabilized. Postponing the bathing of newborns to 48 hours after birth is both effective in maintaining the baby's body temperature and improves skin integrity. Since the thermoregulation abilities of newborns are very limited, it is necessary to maintain body temperature, provide appropriate environmental conditions and warming after bathing.
Although the bathing process, which is an important part of hospital care, protects the health of the newborn, it is also a stressful action for babies and stress symptoms are observed in these babies after bathing. Swaddling the baby in stressful situations such as bathing contributes to the baby's self-calming. The swaddling technique mimics the uterus for newborns and is a technique that ensures the continuation of the intrauterine environment.
Neonatal nursing has come to the forefront in recent years with the development of strategies that increase comfort and has become a frequently used concept in neonatal intensive care units.Among the interventions frequently applied by pediatric nurses to increase comfort are practices such as relaxing positioning, massage, bathing, and wrapping.The practices of nurses to increase the comfort level of the baby and reduce stress with practices with increased level of evidence are very important in terms of nursing care and physical and neuromotor development of the bab.In the light of all this information, this study was planned to investigate the effect of safe swaddling after bathing on stress and comfort in newborns.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 36 baby in experimental group and 36 baby in control group, a total of 72 bany will be included in the study.
| Arm | Type | Receives |
|---|---|---|
| Swaddling after bath group | Experimental | Other: Swaddling after bath groupNewborns in this group will be swaddled safely after bath. |
| No swaddling after bath group | No intervention | –No action will be taken after bath. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The week of gestation is between 37 and 41 weeks,
- Birth weight being 2500 g and above,
- Having spontaneous breathing,
- Its physiological parameters are stable,
- Having completed the first 24 hours of life,
Key exclusion criteria (8 listed)
- Preterms with a gestational age of 22-37 weeks,
- Connected to mechanical ventilator,
- Those who have been wiped or bathed in the last 12 hours,
- Within the first 78 hours of the post-operative period,
- With central catheter,
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 |
|---|---|---|
| Swaddling after bath groupThe babies were bathed in the bathtub. Then swaddling was done. The baby was taken into the incubator and waited for 15 minutes. At the end of 15 minutes, the swaddle was opened quietly and slowly, without disturbing the body posture. Stress and comfort scores were given by two observers by video recording the babies before bathing, before swaddling and after swaddling. Newborns' stress will be assessed with the Newborn Stress Scale and their comfort with the Newborn Comfort Behavior Scale. | Other | Swaddling after bath group |
Primary outcome
change in stress
Time frame: 15th minute after the procedure
The Newborn Stress scale will be used to evaluate stress in babies. The scale consists of 8 subgroups including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities and posture, and a total of 24 items in a 3-point Likert type. In scoring, each subgroup is evaluated between 0-2 points. The minimum score obtained from the scale is 0 points and the maximum is 16 points. An increase in the score indicates that the baby's stress level has increased. A change in stress is expected through safe swaddling after bathing compared to before bathing.
change in comfort
Time frame: 15th minute after the procedure
Newborn Comfort Behavior Scale (COMFORTneo) will be used to evaluate comfort in babies. It has been stated that the lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6 and the highest score is 30. High scores indicate that the baby is not comfortable and needs interventions to provide comfort. A change in comfort is expected after bathing compared to before bathing through safe swaddling.
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 28 Jan 2026.
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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.
Kübra Sevgi, RN principal investigator
Kafkas University
Funda Kardaş Özdemir, PhD study director
Kafkas 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 Swaddling after bath group in people with Stress and Comfort, run by Funda Kardas Ozdemir 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 6 inclusion and 8 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 28 Jan 2026. 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?
change in stress (time frame: 15th minute after the procedure). 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?
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 Jan 2026.