PretermNCT05135429
Effect of Bathing on Pain, Sleep and Vital Signs of Premature Babies
A study testing Bathing in people with Preterm, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a randomized controlled experimental study to determine the effect of bathing given to premature babies on pain, sleep and vital signs. The data of the study were obtained from premature newborns born at 34 weeks and above, who were hospitalized in Selcuk University Hospital Neonatal… Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Preterm
- What is being tested?
- Bathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 4 Sep 2021
- 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 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The gestational age of the baby is 34 weeks and above
- Ability to maintain body temperature
- No contraindication for post-surgical bathing
- Not using any analgesic medication
- Body weight of 2000 g and above
- Baby's oxygen need is less than 30%
- No nutritional intolerance
- Parents' willingness to participate in the research
Who cannot join
- The gestational age of the premature baby is less than 34 weeks.
- Inability to maintain body temperature
- Contraindication of bathing
- Body weight less than 2000 g
- Oxygen requirement greater than 30%
- Presence of nutritional intolerance
- Contraindication of bathing due to clinical course
- Parents' refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted as a randomized controlled experimental study to determine the effect of bathing given to premature babies on pain, sleep and vital signs. The data of the study were obtained from premature newborns born at 34 weeks and above, who were hospitalized in Selcuk University Hospital Neonatal Intensive Care Unit between 1 June and 31 August 2020. The sample size was determined as 64 premature newborns. "Interview and Observation Form, Neonatal Pain/Agitation, Sedation Scale" was used for data collection. The data were evaluated with the SPSS 21.0 package program using percentage, mean, standard deviation, chi-square, t test, Anova and Tukey advanced analysis test.
The research was carried out in the following order. All permissions were obtained for data collection. Individual characteristics were obtained from family members and recorded in the questionnaire. Before the procedure, the pain levels of the newborns were evaluated and recorded. The status of babies in the study or control group was randomly determined according to the hospitalization day (www.randomizer.com).
Read more
The newborns in the study group were given a baby bath. The baby's body temperature, pulse, respiration, systolic and diastolic blood pressure, saturation, oxygen demand, and N-PASS scores were evaluated and recorded by two observers before the bath, at the 15th, 30th and 60th minutes after the bath.
No intervention was given to the newborns in the control group. However, body temperature, pulse, respiration, systolic and diastolic blood pressure, saturation, oxygen demand and N-PASS scores were evaluated and recorded in accordance with the measurement intervals of the newborns in the study group.
Cohen's kappa analysis was performed to assess interobserver agreement. Since the inter-observer agreement was found to be excellent (k=0.85), analysis was performed with an observer evaluation.
All newborns were measured at the same time of the day.
Read the detailed description
The research will be carried out in the second and third level Neonatal Intensive Care Unit of X University Medical Faculty Hospital. 52 nurses and three neonatologists work in the unit. 12 nurses (in-clinical training nurse, nutrition nurse) work during the day and 10 nurses at night. The average number of babies per nurse for care is three. Second and third level patients are hospitalized in the clinic. The total number of beds is 45, with 36 beds at the third level and nine beds at the second level. The average number of babies admitted to the unit and treated is 55/550 monthly/yearly. (Due to the Covid 19 epidemic, the number of hospitalized patients is less than in previous years.)
Outside the unit, there are mother-baby adjustment rooms where the resting needs of mothers are met. There is no restriction on visiting hours for mothers in the clinic, mothers can see and take care of their babies whenever participants want 24/7. Before the Covid 19 epidemic, fathers had visiting hours, but during the epidemic, father visits were abolished.
The sample size was calculated with the G*Power 3.1.5 program with 95% power and 10% difference at 0.05 significance level. The sample size was determined as 64 newborns, 32 children for each group. At the end of the study, Post Hoc power analysis will be performed in order to determine the adequacy of the number of newborns included in the study. When it is determined that 95% power is reached, the data collection process will be terminated.
Randomization of control and study groups; The status of the children to be included in the study in the control or study group will be determined by using "stratification and randomization methods with blocks", taking into account the hospital registration numbers and gender of the newborns. Accordingly, children will be stratified as "girls and boys" for the gender variable. 32 premature newborns will be included in each of the research groups. Since the newborns and their families do not meet each other during the data collection process, the interaction of the newborns in the study and control groups with each other will be prevented.
- Conditions
- Preterm
- Being tested
- Bathing
- 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
The data of the study were obtained from premature newborns born at 34 weeks and above, who were hospitalized.
| Study group | Role | What they receive |
|---|---|---|
| Bathing group | Experimental | Newborn bathing will be done by the same nurse for each newborn in the study group. Since the evening hours are thought to be calmer for the baby bath, the hours between 22:00-24:00 will be chosen. Each newborn will be disinfected with only water beforehand and showered in the sinks used to wash the baby in the clinic. Bath time will be limited to two minutes. Newborns will be dried and dressed immediately after bathing. Monitor probes for monitor follow-ups and blood pressure cuffs will be connected to prevent extra touching during measurements. Receives: Other: Bathing |
| control group | No intervention | Newborns in the control group will not receive any intervention. However, body temperature, pulse, respiration, systolic and diastolic blood pressure, saturation, oxygen demand and N-PASS scores will be evaluated and recorded in accordance with the measurement intervals of the newborns in the study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Evaluation of the change in the pain status of the newborn according to the initial value with Neonatal Pain Agitation And Sedation Scale (N-PASS) just before the bath, 15, 30 and 60 minutes after the bath.
N-PASS, which consists of two separate sections measuring the sedation level and pain level of the baby; It consists of 5 sub-parameters including crying and restlessness, behavior-state, facial expression, hands and feet, body tension and vital signs. A score between 0 and +2 is given for each behavioral and physiological criterion in the evaluation of pain, and between 0 and -2 in the evaluation of sedation. If the baby was born before 30 weeks of gestation, +1 point is added to the total score in the pain assessment. The total pain score ranges from 0 to +11, and the total sedation score ranges from 0 to 10. A high score indicates that the severity of pain is high.
Measured: 60 minutes
sleep time
Measuring the sleep time of the newborn with a stopwatch evaluation
Measured: two hours
body temperature
Evaluation of the change in the temperature of the newborn according to the initial value with a thermometer 15, 30 and 60 minutes after bathing, just before bathing.
Measured: 60 minutes
pulse rate
Evaluation of the newborn's heart rate 15, 30 and 60 minutes after bathing, with a thermometer just before bathing, according to the baseline value.
Measured: 60 minutes
respiratory rate
Evaluation of the change in the respiratory rate of the newborn at 15, 30 and 60 minutes after the bath, by observation (during 1 minute) just before the bath, relative to the baseline value.
Measured: 60 minutes
Blood pressure
Evaluation of the change in blood pressure of the newborn at 15, 30 and 60 minutes after the bath, with a sphygmomanometer just before the bath, according to the baseline value.
Measured: 60 minutes
oxygen saturation
Evaluation of the change in oxygen saturation of the newborn 15, 30 and 60 minutes after the bath, with a saturation device just before the bath, according to the initial value.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Jun 2021
- Primary completion31 Aug 2021
- Study completion4 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Sonay Turkmen, Assoc. Prof, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135429
- Sponsor's protocol ID
- Newborn
- Status last verified
- Nov 2021
- First submitted
- 4 Oct 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bathing on Pain, Sleep and Vital Signs of Premature Babies
- ClinicalTrials.gov ID
- NCT05135429
- Acronym / sponsor ID
- Newborn
- Conditions
- Preterm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 4 Sep 2021 (actual)
- First posted
- 26 Nov 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.
This study was conducted as a randomized controlled experimental study to determine the effect of bathing given to premature babies on pain, sleep and vital signs. The data of the study were obtained from premature newborns born at 34 weeks and above, who were hospitalized in Selcuk University Hospital Neonatal Intensive Care Unit between 1 June and 31 August 2020. The sample size was determined as 64 premature newborns. "Interview and Observation Form, Neonatal Pain/Agitation, Sedation Scale" was used for data collection. The data were evaluated with the SPSS 21.0 package program using percentage, mean, standard deviation, chi-square, t test, Anova and Tukey advanced analysis test.
The research was carried out in the following order. All permissions were obtained for data collection. Individual characteristics were obtained from family members and recorded in the questionnaire. Before the procedure, the pain levels of the newborns were evaluated and recorded. The status of babies in the study or control group was randomly determined according to the hospitalization day (www.randomizer.com).
The newborns in the study group were given a baby bath. The baby's body temperature, pulse, respiration, systolic and diastolic blood pressure, saturation, oxygen demand, and N-PASS scores were evaluated and recorded by two observers before the bath, at the 15th, 30th and 60th minutes after the bath.
No intervention was given to the newborns in the control group. However, body temperature, pulse, respiration, systolic and diastolic blood pressure, saturation, oxygen demand and N-PASS scores were evaluated and recorded in accordance with the measurement intervals of the newborns in the study group.
Cohen's kappa analysis was performed to assess interobserver agreement. Since the inter-observer agreement was found to be excellent (k=0.85), analysis was performed with an observer evaluation.
All newborns were measured at the same time of the day.
Detailed description
The research will be carried out in the second and third level Neonatal Intensive Care Unit of X University Medical Faculty Hospital. 52 nurses and three neonatologists work in the unit. 12 nurses (in-clinical training nurse, nutrition nurse) work during the day and 10 nurses at night. The average number of babies per nurse for care is three. Second and third level patients are hospitalized in the clinic. The total number of beds is 45, with 36 beds at the third level and nine beds at the second level. The average number of babies admitted to the unit and treated is 55/550 monthly/yearly. (Due to the Covid 19 epidemic, the number of hospitalized patients is less than in previous years.)
Outside the unit, there are mother-baby adjustment rooms where the resting needs of mothers are met. There is no restriction on visiting hours for mothers in the clinic, mothers can see and take care of their babies whenever participants want 24/7. Before the Covid 19 epidemic, fathers had visiting hours, but during the epidemic, father visits were abolished.
The sample size was calculated with the G*Power 3.1.5 program with 95% power and 10% difference at 0.05 significance level. The sample size was determined as 64 newborns, 32 children for each group. At the end of the study, Post Hoc power analysis will be performed in order to determine the adequacy of the number of newborns included in the study. When it is determined that 95% power is reached, the data collection process will be terminated.
Randomization of control and study groups; The status of the children to be included in the study in the control or study group will be determined by using "stratification and randomization methods with blocks", taking into account the hospital registration numbers and gender of the newborns. Accordingly, children will be stratified as "girls and boys" for the gender variable. 32 premature newborns will be included in each of the research groups. Since the newborns and their families do not meet each other during the data collection process, the interaction of the newborns in the study and control groups with each other will be prevented.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bathing group | Experimental | Other: BathingNewborn bathing will be done by the same nurse for each newborn in the study group. Since the evening hours are thought to be calmer for the baby bath, the hours between 22:00-24:00 will be chosen. Each newborn will be disinfected with only water beforehand and showered in the sinks used to wash the baby in the clinic. Bath time will be limited to two minutes. Newborns will be dried and dressed immediately after bathing. Monitor probes for monitor follow-ups and blood pressure cuffs will be connected to prevent extra touching during measurements. |
| control group | No intervention | –Newborns in the control group will not receive any intervention. However, body temperature, pulse, respiration, systolic and diastolic blood pressure, saturation, oxygen demand and N-PASS scores will be evaluated and recorded in accordance with the measurement intervals of the newborns in the study group. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The gestational age of the baby is 34 weeks and above
- Ability to maintain body temperature
- No contraindication for post-surgical bathing
- Not using any analgesic medication
- Body weight of 2000 g and above
Key exclusion criteria (8 listed)
- The gestational age of the premature baby is less than 34 weeks.
- Inability to maintain body temperature
- Contraindication of bathing
- Body weight less than 2000 g
- Oxygen requirement greater than 30%
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 |
|---|---|---|
| BathingThe data of the study were obtained from premature newborns born at 34 weeks and above, who were hospitalized. | Other | Bathing group |
Primary outcome
Pain Score
Time frame: 60 minutes
Evaluation of the change in the pain status of the newborn according to the initial value with Neonatal Pain Agitation And Sedation Scale (N-PASS) just before the bath, 15, 30 and 60 minutes after the bath. N-PASS, which consists of two separate sections measuring the sedation level and pain level of the baby; It consists of 5 sub-parameters including crying and restlessness, behavior-state, facial expression, hands and feet, body tension and vital signs. A score between 0 and +2 is given for each behavioral and physiological criterion in the evaluation of pain, and between 0 and -2 in the evaluation of sedation. If the baby was born before 30 weeks of gestation, +1 point is added to the total score in the pain assessment. The total pain score ranges from 0 to +11, and the total sedation score ranges from 0 to 10. A high score indicates that the severity of pain is high.
sleep time
Time frame: two hours
Measuring the sleep time of the newborn with a stopwatch evaluation
body temperature
Time frame: 60 minutes
Evaluation of the change in the temperature of the newborn according to the initial value with a thermometer 15, 30 and 60 minutes after bathing, just before bathing.
pulse rate
Time frame: 60 minutes
Evaluation of the newborn's heart rate 15, 30 and 60 minutes after bathing, with a thermometer just before bathing, according to the baseline value.
respiratory rate
Time frame: 60 minutes
Evaluation of the change in the respiratory rate of the newborn at 15, 30 and 60 minutes after the bath, by observation (during 1 minute) just before the bath, relative to the baseline value.
Blood pressure
Time frame: 60 minutes
Evaluation of the change in blood pressure of the newborn at 15, 30 and 60 minutes after the bath, with a sphygmomanometer just before the bath, according to the baseline value.
oxygen saturation
Time frame: 60 minutes
Evaluation of the change in oxygen saturation of the newborn 15, 30 and 60 minutes after the bath, with a saturation device just before the bath, according to the initial value.
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 26 Nov 2021.
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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, run by Karamanoğlu Mehmetbey 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 8 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 26 Nov 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?
Pain Score (time frame: 60 minutes). The study lists 7 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 26 Nov 2021.