Preterm BirthNCT04811742
Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn
A study testing bathing in people with Preterm Birth, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
Effect of immersion bathing and showering applications on comfort level and physiological parameters of Newborn Read more about this study
- Who is it for?
- Ages 37 to 40 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- bathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 40 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being a newborn born at the 37th gestational week and above,
- Completing 24 hours following the birth
- Having a stable condition (no tachycardia and bradycardia)
Who cannot join
- Having respiratory failure and distress (having respiratory rate between 30-60, not being monitored in the ventilator, having oxygen saturation of 90% and above, having no need for high concentrations of oxygen via methods such as Hood and CPAP)
- Having signs of infection, fever and hypothermia (having an ideal body temperature between 36-37.3 ℃)
- Having neurological problems (hypotonia, hypertonics, etc.), no history of convulsions, using no sedative medication, and having a normal cranial USG.
Trial locations and contacts
1 site in 1 country.
About this study
Effect of immersion bathing and showering applications on comfort level and physiological parameters of Newborn
Read the detailed description
This study aims to determine the effect of immersion bathing and showering on comfort levels and physiological parameters of newborns in neonatal intensive care units.
This is a randomized controlled experimental study. The sample consisted of a total of 69 newborns who were born at the 37th gestational week and above, were referred to the neonatal intensive care unit of a training and research hospital, and met the study inclusion criteria. Study groups were determined through randomization by throwing a dice (immersion bathing group:35, showering group:34). Environmental variables were kept the same for both groups. Physiological parameters (respiration, high heart rate, oxygen saturation, body temperature) and comfort levels of newborns in both groups were compared before, just after and 15 minutes after the bath. Their comfort levels were measured using the Newborn Comfort Behavior Scale (NCBS).
- Conditions
- Preterm Birth
- Being tested
- bathing
- Keywords
- Immersion bathing, showering, comfort, physiological parameters
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bathingOther
immerson bathing and showering
| Study group | Role | What they receive |
|---|---|---|
| immersion bathing group | Experimental | Immersion bathing was started by placing the baby's whole body, except for the head and neck, into a bathtub of warm water with a depth of 13-14 cm. The baby was shampooed and cleaned in the tub. Then, the baby was taken out of the water and rinsed over the tub. Finally, the baby was wrapped with a towel, taken to the radiant and dried, thus the process of bathing was completed. Receives: Other: bathing |
| showering group | Experimental | Shower was started by keeping the baby's face down and firmly gripping the baby from his/her armpit and head by one of the nurse's hands. The baby was washed under running water with the other hand. The second nurse assisted to ensure the flow of water. After the baby was rinsed, he/she was wrapped with a towel, taken to the radiant and dried, thus the process of bathing was completed. Receives: Other: bathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn Comfort Behavior Scale (NCBS)
The scale was developed by Dijk et al. (2009), and its Turkish validity and reliability study was performed by Kahraman et al. (2014). This is a five-point Likert type scale with six factors: alertness, calmness/agitation, respiratory response, physical movement, crying, muscle tone, and facial tension. The NCBS is used by nurses to assess the baby's comfort, pain and distress. Total score ranges from 6 to 30. A lower score indicates a higher newborn comfort level. A total score between 9-13 indicates that the baby is "comfortable", whereas a total score between 14-30 indicates that the baby has pain and distress, that is, is "uncomfortable" and needs comfort enhancing interventions.
Measured: 2 minute
Respiratory rate
Measured: 1 minute
heart rate
Measured: 1 minute
oxygen saturation
Measured: 1 minute
body tempreture
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Sep 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- A power analysis was performed to determine the sample size, which was calculated to include 31 newborns for each study group under the conditions of 0.05 significance level, 0.95 confidence interval and 0.95 power. Due to possible missing data, the sample size was increased by 10%, and the study was completed with a total of 69 newborns, including 35 in the immersion bathing group and 34 in the showering group.In this study, randomization by throwing a dice was used to allocate newborns into study groups. A dice was rolled for each newborn who met the study inclusion criteria, whereby the newborn was assigned to the immersion bathing group when an even number was observed, and to the showering group when an odd number was observed.
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülzade Uysal, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811742
- Sponsor's protocol ID
- 010
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- 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 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn
- ClinicalTrials.gov ID
- NCT04811742
- Acronym / sponsor ID
- 010
- Conditions
- Preterm Birth
- Keywords
- Immersion bathing, showering, comfort, physiological parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 23 Mar 2021 (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.
Effect of immersion bathing and showering applications on comfort level and physiological parameters of Newborn
Detailed description
This study aims to determine the effect of immersion bathing and showering on comfort levels and physiological parameters of newborns in neonatal intensive care units.
This is a randomized controlled experimental study. The sample consisted of a total of 69 newborns who were born at the 37th gestational week and above, were referred to the neonatal intensive care unit of a training and research hospital, and met the study inclusion criteria. Study groups were determined through randomization by throwing a dice (immersion bathing group:35, showering group:34). Environmental variables were kept the same for both groups. Physiological parameters (respiration, high heart rate, oxygen saturation, body temperature) and comfort levels of newborns in both groups were compared before, just after and 15 minutes after the bath. Their comfort levels were measured using the Newborn Comfort Behavior Scale (NCBS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A power analysis was performed to determine the sample size, which was calculated to include 31 newborns for each study group under the conditions of 0.05 significance level, 0.95 confidence interval and 0.95 power. Due to possible missing data, the sample size was increased by 10%, and the study was completed with a total of 69 newborns, including 35 in the immersion bathing group and 34 in the showering group.In this study, randomization by throwing a dice was used to allocate newborns into study groups. A dice was rolled for each newborn who met the study inclusion criteria, whereby the newborn was assigned to the immersion bathing group when an even number was observed, and to the showering group when an odd number was observed.
| Arm | Type | Receives |
|---|---|---|
| immersion bathing group | Experimental | Other: bathingImmersion bathing was started by placing the baby's whole body, except for the head and neck, into a bathtub of warm water with a depth of 13-14 cm. The baby was shampooed and cleaned in the tub. Then, the baby was taken out of the water and rinsed over the tub. Finally, the baby was wrapped with a towel, taken to the radiant and dried, thus the process of bathing was completed. |
| showering group | Experimental | Other: bathingShower was started by keeping the baby's face down and firmly gripping the baby from his/her armpit and head by one of the nurse's hands. The baby was washed under running water with the other hand. The second nurse assisted to ensure the flow of water. After the baby was rinsed, he/she was wrapped with a towel, taken to the radiant and dried, thus the process of bathing was completed. |
Who may qualify
- Ages
- 37 to 40 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Being a newborn born at the 37th gestational week and above,
- Completing 24 hours following the birth
- Having a stable condition (no tachycardia and bradycardia)
Key exclusion criteria (3 listed)
- Having respiratory failure and distress (having respiratory rate between 30-60, not being monitored in the ventilator, having oxygen saturation of 90% and above, having no need for high concentrations of oxygen via methods such as Hood and CPAP)
- Having signs of infection, fever and hypothermia (having an ideal body temperature between 36-37.3 ℃)
- Having neurological problems (hypotonia, hypertonics, etc.), no history of convulsions, using no sedative medication, and having a normal cranial USG.
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 |
|---|---|---|
| bathingimmerson bathing and showering | Other | immersion bathing group, showering group |
Primary outcome
Newborn Comfort Behavior Scale (NCBS)
Time frame: 2 minute
The scale was developed by Dijk et al. (2009), and its Turkish validity and reliability study was performed by Kahraman et al. (2014). This is a five-point Likert type scale with six factors: alertness, calmness/agitation, respiratory response, physical movement, crying, muscle tone, and facial tension. The NCBS is used by nurses to assess the baby's comfort, pain and distress. Total score ranges from 6 to 30. A lower score indicates a higher newborn comfort level. A total score between 9-13 indicates that the baby is "comfortable", whereas a total score between 14-30 indicates that the baby has pain and distress, that is, is "uncomfortable" and needs comfort enhancing interventions.
Respiratory rate
Time frame: 1 minute
heart rate
Time frame: 1 minute
oxygen saturation
Time frame: 1 minute
body tempreture
Time frame: 1 minute
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 23 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bathing in people with Preterm Birth, run by Okan University 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 3 inclusion and 3 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 23 Mar 2021. 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 Behavior Scale (NCBS) (time frame: 2 minute). The study lists 5 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 23 Mar 2021.