Vital Sign MonitoringNCT06836947
The Effect of Two Different Bathing Methods on Vital Signs and Comfort in PICU:Bath Trial
An observational study of Vital Sign Monitoring and Comfort, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The study is a prospective, quasi-experimental study. The population of the study will consist of children who are hospitalized in the Pediatric Intensive Care Unit of SBÜ. İzmir Dr. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Vital Sign Monitoring, Comfort
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Apr 2025to 30 May 2025
- Phase
- Observational
- 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 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: G*power 3.1.9.7 program was used to calculate the sample size required for the study and it was found that a total of 52 patients, 26 patients in each group, should be reached with an effect size of 0.96 (Öz, 2022), power of 0.95 (1-ß) and α:0.05.
Who may be able to join
- Being hospitalized in Behçet Uz Pediatric Intensive Care Unit
- No contraindications to bathing
- Parent's willingness to participate in the study
Who cannot join
- Having a contraindication to bathing
- Parents were not willing to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Katip Çelebi University
Cordaleo, İzmir, 35560
ESRA ARDAHAN AKGÜL
About this study
Official title: The Effect of Two Different Bathing Methods on Vital Signs and Comfort in Pediatric Intensive Care Unit:Bath Trial
The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The study is a prospective, quasi-experimental study.
The population of the study will consist of children who are hospitalized in the Pediatric Intensive Care Unit of SBÜ. İzmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. The vital signs and comfort of the children of the parents who agreed to participate in the study will be measured before bathing (baseline) and care will be taken to ensure that they are similar in both groups.
Read more
Children in the study will not be randomized. In the routine operation of the clinic, traditional bathing is performed once a week and wipe bathing is performed once every two days. Wipe bathing is performed at 36-37 degrees water with 10 ml of chlorhexidine in 200 ml of water. Traditional bathing is also performed with 36-37 degrees water in bed or in the bathtub. In the study, no intervention will be performed and the outcomes will be measured and compared with each other before and after both bathing procedures.
Physiologic parameters including respiratory rate, pulse rate, oxygen saturation and comfort levels of newborns just before, during and after the bathing process (1st and 5th minute) will be evaluated and compared with each other. To avoid bias in the study, all bathing procedures will be performed by Specialist Nurse Esat Erdem GÖKPINAR.
Translated with DeepL.com (free version)
Read the detailed description
The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The study is a prospective, quasi-experimental study.
The population of the study will consist of children who are hospitalized in the Pediatric Intensive Care Unit of SBÜ. İzmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. The vital signs and comfort of the children of the parents who agreed to participate in the study will be measured before bathing (baseline) and care will be taken to ensure that they are similar in both groups.
Children in the study will not be randomized. In the routine operation of the clinic, traditional bathing is performed once a week and wipe bathing is performed once every two days. Wipe bathing is performed at 36-37 degrees water with 10 ml of chlorhexidine in 200 ml of water. Traditional bathing is also performed with 36-37 degrees water in bed or in the bathtub. In the study, no intervention will be performed and the outcomes will be measured and compared with each other before and after both bathing procedures.
Physiologic parameters including respiratory rate, pulse rate, oxygen saturation and comfort levels of newborns just before, during and after the bathing process (1st and 5th minute) will be evaluated and compared with each other. To avoid bias in the study, all bathing procedures will be performed by Specialist Nurse Esat Erdem GÖKPINAR.
Translated with DeepL.com (free version)
- Conditions
- Vital Sign Monitoring, Comfort
- Keywords
- pediatrics, bath, nursing care, vital signs, comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Bathing Group | In traditional bathing, the patient is also bathed in bed with 36-37 degrees water. | |
| Wipe Bathing Group | Wipe bathing is performed with 36-37 degrees water with 10 ml of chlorhexidine in 200 ml of water. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiration
Measured: immediately before and immediately after bath
Pulse
Measured: immediately before and immediately after bath
Saturation
Measured: immediately before and immediately after bath
Mean Blood pressure
Measured: immediately before and immediately after bath
Body Temperature
Measured: immediately before and immediately after bath
Secondary outcomes (1)
comfort scale point
The Comfort scale was developed by Ambuel et al (1992). The Comfort scale is a sedation scoring scale that includes two physiological and six behavioural stress criteria. The sick child is assessed on six behavioural (alertness, calm-agitation, respiratory response, physical movement, muscle tone and facial tension) and two physical parameters (blood pressure and heart rate) within two minutes. Each criterion is scored out of five points. Assessment scores: 27-40: Inadequate sedation, 17-26: Appropriate sedation, 8-16: Excessive sedation. Ambuel et al. reported an internal reliability of 0.84 (p<0.01) for the total score and an internal consistency alpha coefficient of 0.94 for the data collected from 50 observations with 37 patients inthe intensive care unit.
Measured: immediately before and immediately after bath
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start9 Apr 2025
- Primary completion1 May 2025
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Sign MonitoringStudies of the same condition, open and under way.
- More trials run by Izmir Katip Celebi UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA ARDAHAN AKGUL, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836947
- Sponsor's protocol ID
- 006
- Other IDs
- ikçü
- Status last verified
- May 2025
- First submitted
- 16 Feb 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: By ethical rules, patient information will only be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Bathing Methods on Vital Signs and Comfort in Pediatric Intensive Care Unit:Bath Trial
- ClinicalTrials.gov ID
- NCT06836947
- Acronym / sponsor ID
- 006
- Conditions
- Vital Sign Monitoring, Comfort
- Keywords
- pediatrics, bath, nursing care, vital signs, comfort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 20 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.
The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The study is a prospective, quasi-experimental study.
The population of the study will consist of children who are hospitalized in the Pediatric Intensive Care Unit of SBÜ. İzmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. The vital signs and comfort of the children of the parents who agreed to participate in the study will be measured before bathing (baseline) and care will be taken to ensure that they are similar in both groups.
Children in the study will not be randomized. In the routine operation of the clinic, traditional bathing is performed once a week and wipe bathing is performed once every two days. Wipe bathing is performed at 36-37 degrees water with 10 ml of chlorhexidine in 200 ml of water. Traditional bathing is also performed with 36-37 degrees water in bed or in the bathtub. In the study, no intervention will be performed and the outcomes will be measured and compared with each other before and after both bathing procedures.
Physiologic parameters including respiratory rate, pulse rate, oxygen saturation and comfort levels of newborns just before, during and after the bathing process (1st and 5th minute) will be evaluated and compared with each other. To avoid bias in the study, all bathing procedures will be performed by Specialist Nurse Esat Erdem GÖKPINAR.
Translated with DeepL.com (free version)
Detailed description
The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The study is a prospective, quasi-experimental study.
The population of the study will consist of children who are hospitalized in the Pediatric Intensive Care Unit of SBÜ. İzmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. The vital signs and comfort of the children of the parents who agreed to participate in the study will be measured before bathing (baseline) and care will be taken to ensure that they are similar in both groups.
Children in the study will not be randomized. In the routine operation of the clinic, traditional bathing is performed once a week and wipe bathing is performed once every two days. Wipe bathing is performed at 36-37 degrees water with 10 ml of chlorhexidine in 200 ml of water. Traditional bathing is also performed with 36-37 degrees water in bed or in the bathtub. In the study, no intervention will be performed and the outcomes will be measured and compared with each other before and after both bathing procedures.
Physiologic parameters including respiratory rate, pulse rate, oxygen saturation and comfort levels of newborns just before, during and after the bathing process (1st and 5th minute) will be evaluated and compared with each other. To avoid bias in the study, all bathing procedures will be performed by Specialist Nurse Esat Erdem GÖKPINAR.
Translated with DeepL.com (free version)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Bathing Group | – | –In traditional bathing, the patient is also bathed in bed with 36-37 degrees water. |
| Wipe Bathing Group | – | –Wipe bathing is performed with 36-37 degrees water with 10 ml of chlorhexidine in 200 ml of water. |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- G*power 3.1.9.7 program was used to calculate the sample size required for the study and it was found that a total of 52 patients, 26 patients in each group, should be reached with an effect size of 0.96 (Öz, 2022), power of 0.95 (1-ß) and α:0.05.
Key inclusion criteria (3 listed)
- Being hospitalized in Behçet Uz Pediatric Intensive Care Unit
- No contraindications to bathing
- Parent's willingness to participate in the study
Key exclusion criteria (2 listed)
- Having a contraindication to bathing
- Parents were not willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiration
Time frame: immediately before and immediately after bath
Pulse
Time frame: immediately before and immediately after bath
Saturation
Time frame: immediately before and immediately after bath
Mean Blood pressure
Time frame: immediately before and immediately after bath
Body Temperature
Time frame: immediately before and immediately after bath
1 secondary outcome
comfort scale point
Time frame: immediately before and immediately after bath
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 7 May 2025.
- Individual participant dataSharing planned: Undecided. By ethical rules, patient information will only be shared upon request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Sign Monitoring and Comfort, run by Izmir Katip Celebi 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 2 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: looking for participants now, as of the sponsor's last update on 7 May 2025. 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?
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 ESRA ARDAHAN AKGÜL, Ast. Prof (00902323293535 ext. 4856, esraardahan90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiration (time frame: immediately before and immediately after bath). 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 7 May 2025.