Bathtub BathNCT06808958
The Effect of Bathtub Bath on Stress and Comfort in Infants Receiving Phototherapy
A study testing Experimental (Bathtub Bath) Group in people with Bathtub Bath, run by Erzincan Binali Yildirim Universitesi.
Trial summary
After intrauterine life, intensive care is a stressful environment for newborns who have to start their lives in the NICU. Many care practices in the NICU, including environmental factors (such as light, sound), heel prick blood collection, routine care, invasive interventions and bathing, are sources of stress for… Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Bathtub Bath
- What is being tested?
- Experimental (Bathtub Bath) Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Newborns with a gestational age of 37 weeks and above
- Birth weight of 2500 grams and above
- Having completed 24 hours after birth
- The newborn is hospitalized with a diagnosis of physiological hyperbilirubinemia and is receiving phototherapy
- No accompanying disease
- No accompanying treatment
Show all 16Show fewer
- Stable physiological parameters (no tachycardia and bradycardia)
- No respiratory failure or distress (respiratory rate between 30-60, not being monitored on a ventilator, oxygen saturation of 90% and above, no need for continuous high concentration oxygen with methods such as Hood, CPAP, etc.)
- The baby is hospitalized during data collection
- The parents are willing for the newborn to participate in the study Exclusion Criteria
- Preterms with a gestational age of 22-37 weeks,
- The newborn has another concomitant disease diagnosis
- Has been wiped or bathed in a tub within the last 12 hours
- Has been hospitalized with a diagnosis of pathological hyperbilirubinemia
- Has been given sedatives and/or muscle relaxants
- The parent does not want the newborn to participate in the study or wants/wants to withdraw from the study while the study is ongoing
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
After intrauterine life, intensive care is a stressful environment for newborns who have to start their lives in the NICU. Many care practices in the NICU, including environmental factors (such as light, sound), heel prick blood collection, routine care, invasive interventions and bathing, are sources of stress for newborns. At the same time, the physical structure of the NICU, that is, factors such as sound, light, odor, and the physiological and anatomical immaturity of newborn babies, routine care and invasive procedures can reduce the comfort of the baby. Controlling the factors that may cause stress in the infant in the NICU and reducing stress and increasing comfort at the same time may affect the baby's healing process and discharge process.
Recently, nursing care practices that reduce stress and increase comfort are at the forefront and have become an important concept today. In the literature, massage, kangaroo care, swaddling, listening to the mother's voice, listening to music, positioning, mother-scented hand simulation, breastfeeding, wrapping, bathing . Neonatal bathing is among the practices frequently performed by neonatal intensive care nurses to reduce the stress of the newborn and increase comfort Bathing is a basic skin care process for newborns. Bathing is known to have beneficial effects for infants. It is reported that bathing causes relaxation in muscles, is calming and relaxing, is effective in regulating body temperature and reducing pain, regulating blood circulation and respiratory system, and supporting parent-infant bonding (interaction).
Read more
Bathing is a basic skin care process for newborns. Bathing is known to have beneficial effects for infants. It is reported that bathing causes relaxation in muscles, is calming and relaxing, is effective in regulating body temperature and reducing pain, regulating blood circulation and respiratory system, and supporting parent-infant bonding (interaction). Bowles (2013) found that neonatal bathing exfoliates dead skin cells, re-moisturizes the skin surface, reduces infant stress and agitation to provide comfort, encourages flexion and containment, and eventually provides developmentally supportive care. In the literature, there are many studies showing that bathing is also effective in reducing bilirubin levels in infants hospitalized with hyperbilirubinemia in neonatal intensive care units.
Stimuli such as lighting, noise and pain from repeated medical interventions in the NICU can cause stress in infants. Excessive lighting can cause negative effects such as weight gain disorder, sleep disturbance and stress in infants. Since phototherapy light is not only a source of stress for the baby receiving phototherapy but also one of the important factors affecting the comfort level, the comfort of babies receiving phototherapy should be monitored frequently. The physical conditions of NICUs, physiologic and anatomic conditions of the infants receiving treatment, invasive interventions and care lead to a decrease in the comfort level of newborns. This situation negatively affects the discharge time and recovery of newborns. Therefore, this study will be conducted to examine the effect of bathtub bathing on stress level and comfort in infants receiving phototherapy in neonatal intensive care.
- Conditions
- Bathtub Bath
- Being tested
- Experimental (Bathtub Bath) Group
- Keywords
- Bathtub Bath, Infants, Phototherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental (Bathtub Bath) GroupBehavioural
The newborn's eyes will be covered with a phototherapy eye patch and placed in the baby's jeans and the treatment will be started. The position (face down and back down) is changed every two hours. And phototherapy is paused every three hours for feeding. Therefore, the bath will be given half an hour after the phototherapy application is completed before the two phototherapy sessions. The physiological parameters of the newborns will be evaluated 0 minutes before the bath. Then the bathtub bath application will be started. The bath application will be completed in a time not exceeding 5 minutes. Physiological parameters, stress and comfort will be assessed 15 minutes after bathing. Then, 15 minutes after starting the phototherapy session and 15 minutes before ending the phototherapy session, physiological parameters, stress and comfort will be assessed. The measured physiological parameters (respiratory rate, heart rate, oxygen saturation and body temperature), stress and comfort scor
| Study group | Role | What they receive |
|---|---|---|
| Experimental (Bathtub Bath) Group | Experimental | The newborn's eyes will be covered with a phototherapy eye patch and placed in the baby's jeans and the treatment will be started. Therefore, the bath will be given half an hour after the phototherapy application is completed before the two phototherapy sessions. The physiological parameters of the newborns will be evaluated 0 minutes before the bath. Then the bathtub bath application will be started. The bath application will be completed in a time not exceeding 5 minutes. Physiological parameters, stress and comfort will be assessed 15 minutes after bathing. Then, 15 minutes after starting the phototherapy session and 15 minutes before ending the phototherapy session, physiological parameters, stress and comfort will be assessed. The measured physiological parameters (respiratory rate, heart rate, oxygen saturation and body temperature), stress and comfort stress and comfort scores will be recorded on the Newborn Follow-up Form. Receives: Behavioral: Experimental (Bathtub Bath) Group |
| Control Group | No intervention | nformation about the newborns selected for the control group (gender of the baby, gestational week, delivery method, etc.) will be taken from the newborn file and recorded on the form containing the newborn's introductory information. Physiological parameter, stress and comfort assessments will be performed on the newborns in the control group without any different application, immediately before the phototherapy session starts, 0 minutes before, 15 minutes after starting and 15 minutes before the phototherapy session ends. The measured physiological parameters (respiratory rate, heart rate, oxygen saturation and body temperature), stress and comfort scores will be recorded on the Newborn Follow-up Form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn Stress Scale
The Newborn Stress Scale (NSS), developed by Ceylan and Bolışık (2017), consists of a total of 24 items on a 3-point Likert scale. The scale items include 8 subgroups including facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities, and posture, and each subgroup is evaluated between 0-2 points in the scoring. The minimum score is zero and the maximum score is 16 points. As the score increases, the baby's stress level increases.
Measured: Physiological parameters, stress and comfort will be assessed 15 minutes after bathing. Then, 15 minutes after starting the phototherapy session and 15 minutes before ending the phototherapy session, 0 minutes before, 15 minutes after starting and 15 min
Secondary outcomes (1)
Newborn Comfort Behavior Scale
The scale is a Likert-type scale developed to be used in the evaluation of sedation and comfort needs, pain and distress of newborns monitored in intensive care. Van Dijk et al. In 2009, the scale was revised and the COMFORTneo scale was validated and its reliability was established to measure only behavior in newborns without physiological parameters. The Neonatal Comfort Behavior Scale (NCBSS), whose validity and reliability were established by Kahraman, Başbakkal and Yalaz (2014), is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension and muscle tone.
Measured: 0 minutes before, 15 minutes after starting and 15 minutes before the phototherapy session ends. stress and comfort will be assessed 15 minutes after bathing. Then, 15 minutes after starting the phototherapy session and 15 minutes before ending the photo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start15 Feb 2025 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bathtub BathStudies 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
- Parallel groups
- Model description
- The newborn's eyes will be covered with a phototherapy eye patch and placed in the baby's jeans and the treatment will be started. The position (face down and back down) is changed every two hours. And phototherapy is paused every three hours for feeding. Therefore, the bath will be given half an hour after the phototherapy application is completed before the two phototherapy sessions. The physiological parameters of the newborns will be evaluated 0 minutes before the bath. Then the bathtub bath application will be started. The bath application will be completed in a time not exceeding 5 minutes. Physiological parameters, stress and comfort will be assessed 15 minutes after bathing. Then, 15 minutes after starting the phototherapy session and 15 minutes before ending the phototherapy session, physiological parameters, stress and comfort will be assessed. The measured physiological parameters (respiratory rate, heart rate, oxygen saturation and body temperature), stress and comfort scor
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan Binali Yildirim Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necla Kasımoğlu, Erzincan Binali Yildirim Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808958
- Sponsor's protocol ID
- 124567
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bathtub Bath on Stress and Comfort in Infants Receiving Phototherapy
- ClinicalTrials.gov ID
- NCT06808958
- Acronym / sponsor ID
- 124567
- Conditions
- Bathtub Bath
- Keywords
- Bathtub Bath, Infants, Phototherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Erzincan Binali Yildirim UniversitesiUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 5 Feb 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.
After intrauterine life, intensive care is a stressful environment for newborns who have to start their lives in the NICU. Many care practices in the NICU, including environmental factors (such as light, sound), heel prick blood collection, routine care, invasive interventions and bathing, are sources of stress for newborns. At the same time, the physical structure of the NICU, that is, factors such as sound, light, odor, and the physiological and anatomical immaturity of newborn babies, routine care and invasive procedures can reduce the comfort of the baby. Controlling the factors that may cause stress in the infant in the NICU and reducing stress and increasing comfort at the same time may affect the baby's healing process and discharge process.
Recently, nursing care practices that reduce stress and increase comfort are at the forefront and have become an important concept today. In the literature, massage, kangaroo care, swaddling, listening to the mother's voice, listening to music, positioning, mother-scented hand simulation, breastfeeding, wrapping, bathing . Neonatal bathing is among the practices frequently performed by neonatal intensive care nurses to reduce the stress of the newborn and increase comfort Bathing is a basic skin care process for newborns. Bathing is known to have beneficial effects for infants. It is reported that bathing causes relaxation in muscles, is calming and relaxing, is effective in regulating body temperature and reducing pain, regulating blood circulation and respiratory system, and supporting parent-infant bonding (interaction).
Bathing is a basic skin care process for newborns. Bathing is known to have beneficial effects for infants. It is reported that bathing causes relaxation in muscles, is calming and relaxing, is effective in regulating body temperature and reducing pain, regulating blood circulation and respiratory system, and supporting parent-infant bonding (interaction). Bowles (2013) found that neonatal bathing exfoliates dead skin cells, re-moisturizes the skin surface, reduces infant stress and agitation to provide comfort, encourages flexion and containment, and eventually provides developmentally supportive care. In the literature, there are many studies showing that bathing is also effective in reducing bilirubin levels in infants hospitalized with hyperbilirubinemia in neonatal intensive care units.
Stimuli such as lighting, noise and pain from repeated medical interventions in the NICU can cause stress in infants. Excessive lighting can cause negative effects such as weight gain disorder, sleep disturbance and stress in infants. Since phototherapy light is not only a source of stress for the baby receiving phototherapy but also one of the important factors affecting the comfort level, the comfort of babies receiving phototherapy should be monitored frequently. The physical conditions of NICUs, physiologic and anatomic conditions of the infants receiving treatment, invasive interventions and care lead to a decrease in the comfort level of newborns. This situation negatively affects the discharge time and recovery of newborns. Therefore, this study will be conducted to examine the effect of bathtub bathing on stress level and comfort in infants receiving phototherapy in neonatal intensive care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The newborn's eyes will be covered with a phototherapy eye patch and placed in the baby's jeans and the treatment will be started. The position (face down and back down) is changed every two hours. And phototherapy is paused every three hours for feeding. Therefore, the bath will be given half an hour after the phototherapy application is completed before the two phototherapy sessions. The physiological parameters of the newborns will be evaluated 0 minutes before the bath. Then the bathtub bath application will be started. The bath application will be completed in a time not exceeding 5 minutes. Physiological parameters, stress and comfort will be assessed 15 minutes after bathing. Then, 15 minutes after starting the phototherapy session and 15 minutes before ending the phototherapy session, physiological parameters, stress and comfort will be assessed. The measured physiological parameters (respiratory rate, heart rate, oxygen saturation and body temperature), stress and comfort scor
| Arm | Type | Receives |
|---|---|---|
| Experimental (Bathtub Bath) Group | Experimental | Behavioral: Experimental (Bathtub Bath) GroupThe newborn's eyes will be covered with a phototherapy eye patch and placed in the baby's jeans and the treatment will be started. Therefore, the bath will be given half an hour after the phototherapy application is completed before the two phototherapy sessions. The physiological parameters of the newborns will be evaluated 0 minutes before the bath. Then the bathtub bath application will be started. The bath application will be completed in a time not exceeding 5 minutes. Physiological parameters, stress and comfort will be assessed 15 minutes after bathing. Then, 15 minutes after starting the phototherapy session and 15 minutes before ending the phototherapy session, physiological parameters, stress and comfort will be assessed. The measured physiological parameters (respiratory rate, heart rate, oxygen saturation and body temperature), stress and comfort stress and comfort scores will be recorded on the Newborn Follow-up Form. |
| Control Group | No intervention | –nformation about the newborns selected for the control group (gender of the baby, gestational week, delivery method, etc.) will be taken from the newborn file and recorded on the form containing the newborn's introductory information. Physiological parameter, stress and comfort assessments will be performed on the newborns in the control group without any different application, immediately before the phototherapy session starts, 0 minutes before, 15 minutes after starting and 15 minutes before the phototherapy session ends. The measured physiological parameters (respiratory rate, heart rate, oxygen saturation and body temperature), stress and comfort scores will be recorded on the Newborn Follow-up Form. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Newborns with a gestational age of 37 weeks and above
- Birth weight of 2500 grams and above
- Having completed 24 hours after birth
- The newborn is hospitalized with a diagnosis of physiological hyperbilirubinemia and is receiving phototherapy
- No accompanying disease
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Experimental (Bathtub Bath) GroupThe newborn's eyes will be covered with a phototherapy eye patch and placed in the baby's jeans and the treatment will be started. The position (face down and back down) is changed every two hours. And phototherapy is paused every three hours for feeding. Therefore, the bath will be given half an hour after the phototherapy application is completed before the two phototherapy sessions. The physiological parameters of the newborns will be evaluated 0 minutes before the bath. Then the bathtub bath application will be started. The bath application will be completed in a time not exceeding 5 minutes. Physiological parameters, stress and comfort will be assessed 15 minutes after bathing. Then, 15 minutes after starting the phototherapy session and 15 minutes before ending the phototherapy session, physiological parameters, stress and comfort will be assessed. The measured physiological parameters (respiratory rate, heart rate, oxygen saturation and body temperature), stress and comfort scor | Behavioural | Experimental (Bathtub Bath) Group |
Primary outcome
Newborn Stress Scale
Time frame: Physiological parameters, stress and comfort will be assessed 15 minutes after bathing. Then, 15 minutes after starting the phototherapy session and 15 minutes before ending the phototherapy session, 0 minutes before, 15 minutes after starting and 15 min
The Newborn Stress Scale (NSS), developed by Ceylan and Bolışık (2017), consists of a total of 24 items on a 3-point Likert scale. The scale items include 8 subgroups including facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities, and posture, and each subgroup is evaluated between 0-2 points in the scoring. The minimum score is zero and the maximum score is 16 points. As the score increases, the baby's stress level increases.
1 secondary outcome
Newborn Comfort Behavior Scale
Time frame: 0 minutes before, 15 minutes after starting and 15 minutes before the phototherapy session ends. stress and comfort will be assessed 15 minutes after bathing. Then, 15 minutes after starting the phototherapy session and 15 minutes before ending the photo
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental (Bathtub Bath) Group in people with Bathtub Bath, run by Erzincan Binali Yildirim Universitesi.
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 16 inclusion and 0 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: opening soon, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NECLA KASIMOĞLU, Dr (05072275742, necla_24celik@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newborn Stress Scale (time frame: Physiological parameters, stress and comfort will be assessed 15 minutes after bathing. Then, 15 minutes after starting the phototherapy session and 15 minutes before ending the phototherapy session, 0 minutes before, 15 minutes after starting and 15 min). 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 5 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.