VitalNCT06872476
Bed Baths' Impact on Blood Gases and Vital Signs in Children
A study testing bed bath and bed bath with heat in people with Vital and Blood Gases, run by Nuh Naci Yazgan University.
Trial summary
Study Overview: This randomized cross-over study investigated the effects of bed baths on the vital signs and blood gas values of children. The children received two bed baths: one under a heater and the other at room temperature. The order of the bed baths was randomized. Read more about this study
- Who is it for?
- Ages 2 months to 3 years
- Conditions the study is for
- Vital, Blood Gases
- What is being tested?
- bed bath and bed bath with heat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2015to 15 Mar 2018
- 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 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who are hospitalized for respiratory failures and in mechanical ventilators,
- having normal body temperatures
Who cannot join
- Total Parenterally Nutrition
- any chronic diseases
- any disease or condition which bathing would cause problems
About this study
Official title: Influence of Bed Baths on Blood Gases and Vital Signs Given Under Heat to Children: Randomized Cross-Over Study
Study Overview:
This randomized cross-over study investigated the effects of bed baths on the vital signs and blood gas values of children. The children received two bed baths: one under a heater and the other at room temperature. The order of the bed baths was randomized.
Read more
Methods:
The study involved children aged 1-36 months hospitalized in the Pediatric Intensive Care Unit (PICU). The bed baths were administered by a research nurse and assistant staff between 16:00 and 24:00 on weekends. The vital signs and capillary blood gas values (pH, PaO2, PaCO2, HCO3-) were measured three times: before, immediately after, and one hour after the bath. Data on heart rate, blood pressure, SpO2, and blood gas values were collected using specialized equipment.
Heating and Bathing Process:
For the heated bed bath, two heaters were positioned 50-60 cm above the child's bed, and the bath was conducted using soapy water at 37-40°C, followed by clear water.
Population:
The study was conducted in the PICU of a children's hospital, including children aged 1-36 months who were on mechanical ventilation, had normal body temperatures, and did not have chronic diseases. A total of 12 children participated over a period of two years.
Statistical Analysis:
Data were analyzed using IBM SPSS Statistics. Descriptive statistics such as percentages, averages, and standard deviations were used. The normality of the data was assessed, and repeated measurements were analyzed using ANOVA.
Read the detailed description
Methods/Methodology This study was conducted in a randomized cross-over study. Study Design and Procedures In the study, children were given bed baths twice. One of the bed baths was done under heater and the other at room temperature. Which bed bath would be given first was determined by simple randomization (by lottery method). The bed baths of children participating in the study were given by a research nurse and an assistant staff. Children's bed baths are routinely given between 16:00 and 24:00 on weekends. Children who need a bed bath on weekdays are given a wiping bath by the caring nurse. The bed bath was performed in approximately at 21-240C room temperature in 20 to 25 minutes, with soapy water at 37-400C followed by clear water. The bed baths which were performed at under two heaters located 50-60 centimeters away from the bed of the children.
Measurements Applied at the Clinic The vital signs and capillary (right hand, middle finger) blood gas values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath.
- Heart Rate Heart rates were measured using a PVM-2701 monitor (Nihon Kohden Corp., Tokyo, Japan).
- Blood Pressure Blood pressures were measured manually over a period of one minute by a nursing team.
- pH, PaO2, PaCO2 and HCO3- Measurements For all patients, pH, PaO2, PaCO2 and HCO3- measurements were recorded from capillary blood samples, using an ABL800 FLLEX blood gas analyzer (Radiometer Medical A/S, Brønshøj, Denmark).
- SpO2 Measurements SpO2 was measured non-invasively using a PVM-2701 monitor (Nihon Kohden, Corp.). The saturation probe was applied to the patient's right palm. Daily measurements were recorded throughout each patient's stay in the Pediatric Intensive Care Unit (PICU).
- Patient Warming To heat the environment during bathing, the heating devices (Patient Warming System, Nellcor) were fixed 50-60 centimeters upwards from the bed on two sides, both left and right Population and Samples The study was conducted in the PICU of the Children's Health Hospital affiliated with the Central Anatolian Public Hospitals Association. The intensive care unit where the study was conducted is an 8-bed 3rd degree PICU that cares for children between the ages of 1 month and 18 years. The data collection process took 2 years due to the long-term hospitalization of children in the unit and only children aged 1-36 months (Because of clinical nurses observed that the vital signs and blood gas values of children with mechanical ventilators for 1-36 months were affected after bedside bathing and that mechanical ventilator settings were changed) included in the study, and 12 children were reached in a two-year period. Children who are hospitalized for respiratory failures and in mechanical ventilators, not given Total Parenterally Nutrient, are normal body temperatures, are not suffering from any chronic diseases, and bathing would not cause problems was included.
Data Management and Statistical Analysis The data was evaluated in the IBM SPSS Statistics Standard Concurrent User V 25 (IBM Corp., Armonk, NY, USA) statistical package program. Number of units (n), percentage (%), average ± standard deviation (¯x±ss), median (M), and 25-75. percentile is given as descriptive statistics. Normal distribution of data regarding the numeric variables was evaluated with Q-Q plots and Shapiro-Wilk test for normality. Repeated measurements were variance analyzed (ANOVA).
- Conditions
- Vital, Blood Gases
- Being tested
- bed bath, bed bath with heat
- Keywords
- bed bath, blood gases, mechanical ventilator, pediatric intensive care, vital signs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bed bathOther
bed bath with heatOther
| Study group | Role | What they receive |
|---|---|---|
| bed bath | Experimental | This practice is a complementary and supportive care intervention. Receives: Other: bed bath; Other: bed bath with heat |
| bed bath with heat | Experimental | This practice is a complementary and supportive care intervention.In detail, this bed baths which were performed at under two heaters located 50-60 centimeters away from the bed of the children. Receives: Other: bed bath; Other: bed bath with heat |
What is being measured
The primary outcome is the main question the study is designed to answer.
temperature measure
Celcius
Measured: The bady temperature values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.
Pulse
per minute
Measured: The heart pulse values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.
blood pressure
mmHg
Measured: The blood pressure values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath.The values were measured three times in each bed bath, for a total of six times.
oxygen saturation
Measured: The oxygen saturation values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.
blood pH
pH
Measured: The capillary blood pH values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.
PaO2
Measured: The capillary blood PaO2 values were evaluated for total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.
PaCO2
Measured: The capillary blood PaCO2 values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath.The values were measured three times in each bed bath, for total of six times.
HCO3-
mEq/L
Measured: The capillary blood HCO3- values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bathThe values were measured three times in each bed bath, for total of six times.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start15 Dec 2015
- Primary completion30 Dec 2017
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VitalStudies 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
- Crossover
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuh Naci Yazgan University
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University
- Responsible party
- Principal investigator, Dr. Zübeyde KORKMAZ, Nuh Naci Yazgan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872476
- Sponsor's protocol ID
- NuhNaciYazganU3
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kzl H, Sendir M. The Effects of Bed Bathing on Vital Signs and Oxygen Saturation in Children Who Are Connected to Mechanical Ventilation. Dimens Crit Care Nurs. 2018 Sep/Oct;37(5):272-278. doi: 10.1097/DCC.0000000000000312.
PubMed 30063523
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Bed Baths on Blood Gases and Vital Signs Given Under Heat to Children: Randomized Cross-Over Study
- ClinicalTrials.gov ID
- NCT06872476
- Acronym / sponsor ID
- NuhNaciYazganU3
- Conditions
- Vital, Blood Gases
- Keywords
- bed bath, blood gases, mechanical ventilator, pediatric intensive care, vital signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nuh Naci Yazgan UniversityUniversity, hospital or other
- Collaborators
- TC Erciyes University
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 12 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.
Study Overview:
This randomized cross-over study investigated the effects of bed baths on the vital signs and blood gas values of children. The children received two bed baths: one under a heater and the other at room temperature. The order of the bed baths was randomized.
Methods:
The study involved children aged 1-36 months hospitalized in the Pediatric Intensive Care Unit (PICU). The bed baths were administered by a research nurse and assistant staff between 16:00 and 24:00 on weekends. The vital signs and capillary blood gas values (pH, PaO2, PaCO2, HCO3-) were measured three times: before, immediately after, and one hour after the bath. Data on heart rate, blood pressure, SpO2, and blood gas values were collected using specialized equipment.
Heating and Bathing Process:
For the heated bed bath, two heaters were positioned 50-60 cm above the child's bed, and the bath was conducted using soapy water at 37-40°C, followed by clear water.
Population:
The study was conducted in the PICU of a children's hospital, including children aged 1-36 months who were on mechanical ventilation, had normal body temperatures, and did not have chronic diseases. A total of 12 children participated over a period of two years.
Statistical Analysis:
Data were analyzed using IBM SPSS Statistics. Descriptive statistics such as percentages, averages, and standard deviations were used. The normality of the data was assessed, and repeated measurements were analyzed using ANOVA.
Detailed description
Methods/Methodology This study was conducted in a randomized cross-over study. Study Design and Procedures In the study, children were given bed baths twice. One of the bed baths was done under heater and the other at room temperature. Which bed bath would be given first was determined by simple randomization (by lottery method). The bed baths of children participating in the study were given by a research nurse and an assistant staff. Children's bed baths are routinely given between 16:00 and 24:00 on weekends. Children who need a bed bath on weekdays are given a wiping bath by the caring nurse. The bed bath was performed in approximately at 21-240C room temperature in 20 to 25 minutes, with soapy water at 37-400C followed by clear water. The bed baths which were performed at under two heaters located 50-60 centimeters away from the bed of the children.
Measurements Applied at the Clinic The vital signs and capillary (right hand, middle finger) blood gas values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath.
- Heart Rate Heart rates were measured using a PVM-2701 monitor (Nihon Kohden Corp., Tokyo, Japan).
- Blood Pressure Blood pressures were measured manually over a period of one minute by a nursing team.
- pH, PaO2, PaCO2 and HCO3- Measurements For all patients, pH, PaO2, PaCO2 and HCO3- measurements were recorded from capillary blood samples, using an ABL800 FLLEX blood gas analyzer (Radiometer Medical A/S, Brønshøj, Denmark).
- SpO2 Measurements SpO2 was measured non-invasively using a PVM-2701 monitor (Nihon Kohden, Corp.). The saturation probe was applied to the patient's right palm. Daily measurements were recorded throughout each patient's stay in the Pediatric Intensive Care Unit (PICU).
- Patient Warming To heat the environment during bathing, the heating devices (Patient Warming System, Nellcor) were fixed 50-60 centimeters upwards from the bed on two sides, both left and right Population and Samples The study was conducted in the PICU of the Children's Health Hospital affiliated with the Central Anatolian Public Hospitals Association. The intensive care unit where the study was conducted is an 8-bed 3rd degree PICU that cares for children between the ages of 1 month and 18 years. The data collection process took 2 years due to the long-term hospitalization of children in the unit and only children aged 1-36 months (Because of clinical nurses observed that the vital signs and blood gas values of children with mechanical ventilators for 1-36 months were affected after bedside bathing and that mechanical ventilator settings were changed) included in the study, and 12 children were reached in a two-year period. Children who are hospitalized for respiratory failures and in mechanical ventilators, not given Total Parenterally Nutrient, are normal body temperatures, are not suffering from any chronic diseases, and bathing would not cause problems was included.
Data Management and Statistical Analysis The data was evaluated in the IBM SPSS Statistics Standard Concurrent User V 25 (IBM Corp., Armonk, NY, USA) statistical package program. Number of units (n), percentage (%), average ± standard deviation (¯x±ss), median (M), and 25-75. percentile is given as descriptive statistics. Normal distribution of data regarding the numeric variables was evaluated with Q-Q plots and Shapiro-Wilk test for normality. Repeated measurements were variance analyzed (ANOVA).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bed bath | Experimental | Other: bed bath, Other: bed bath with heatThis practice is a complementary and supportive care intervention. |
| bed bath with heat | Experimental | Other: bed bath, Other: bed bath with heatThis practice is a complementary and supportive care intervention.In detail, this bed baths which were performed at under two heaters located 50-60 centimeters away from the bed of the children. |
Who may qualify
- Ages
- 2 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children who are hospitalized for respiratory failures and in mechanical ventilators,
- having normal body temperatures
Key exclusion criteria (3 listed)
- Total Parenterally Nutrition
- any chronic diseases
- any disease or condition which bathing would cause problems
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 |
|---|---|---|
| bed bath | Other | bed bath, bed bath with heat |
| bed bath with heat | Other | bed bath, bed bath with heat |
Primary outcome
temperature measure
Time frame: The bady temperature values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.
Celcius
Pulse
Time frame: The heart pulse values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.
per minute
blood pressure
Time frame: The blood pressure values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath.The values were measured three times in each bed bath, for a total of six times.
mmHg
oxygen saturation
Time frame: The oxygen saturation values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.
blood pH
Time frame: The capillary blood pH values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.
pH
PaO2
Time frame: The capillary blood PaO2 values were evaluated for total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.
PaCO2
Time frame: The capillary blood PaCO2 values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath.The values were measured three times in each bed bath, for total of six times.
HCO3-
Time frame: The capillary blood HCO3- values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bathThe values were measured three times in each bed bath, for total of six times.
mEq/L
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 12 Mar 2025.
- Background: PubMed 30063523Kzl H, Sendir M. The Effects of Bed Bathing on Vital Signs and Oxygen Saturation in Children Who Are Connected to Mechanical Ventilation. Dimens Crit Care Nurs. 2018 Sep/Oct;37(5):272-278. doi: 10.1097/DCC.0000000000000312.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing bed bath and bed bath with heat in people with Vital and Blood Gases, run by Nuh Naci Yazgan University.
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 2 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 12 Mar 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?
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?
temperature measure (time frame: The bady temperature values were evaluated for a total of three times; five minutes before the bed bath, five minutes after the bed bath, and an hour after the bed bath. The values were measured three times in each bed bath, for a total of six times.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06872476, which also lists 1 linked publication.
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 12 Mar 2025.