Urine Specimen CollectionNCT06188078
The Effect of Bladder Stimulation Technique and Bathing Method on Urine Collection in Term Babies
A study testing The bladder stimulation technique and Bath in people with Urine Specimen Collection, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
Purpose of the Study: The aim of this study is to examine the effect of bladder stimulation technique and bathing method on urine collection in term infants hospitalized in the neonatal intensive care unit. Content of the Study: This study will consist of 3 groups. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Urine Specimen Collection
- What is being tested?
- The bladder stimulation technique and Bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Mar 2024to 28 Jul 2024
- 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 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term babies whose gestational age is 37+6 days and above,
- Full-term newborns aged 1-28 days
- Orally fed babies
- Babies with stable health status,
- Babies who do not have urological, neurological diseases, or anatomical anomalies that may affect bladder function,
- Babies of parents who voluntarily agree to participate in the study will be included in the study.
Who cannot join
- Preterm babies whose gestational age is below 37+6 days,
- Babies fed with an orogastric tube (OGS),
- Babies with serious health problems (such as respiratory distress),
- Babies with urological, neurological diseases or anatomical anomalies that may affect bladder function,
- Babies of parents who do not agree to participate in the study will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Bladder Stimulation Technique and Bathing Method on Urine Collection in Term Babies: A Randomized Controlled Trial
Purpose of the Study: The aim of this study is to examine the effect of bladder stimulation technique and bathing method on urine collection in term infants hospitalized in the neonatal intensive care unit.
Content of the Study: This study will consist of 3 groups. Babies in the 1st group, the control group, will be fed only with breast milk or formula, and after 25 minutes, a urine bag will be inserted and urination will be expected. The babies in the second group, the bladder stimulation technique application group, will also be placed in a urine bag 25 minutes after feeding. Then the bladder stimulation technique will be applied. This technique; consists of two consecutive maneuvers. In the first maneuver, the bladder (Urine Bag) is stimulated by hitting the suprapubic (lower parts of the abdomen) area for 30 seconds at a frequency of 100 touches per minute. In the second maneuver, a 30-second circular massage is applied to the paravertebral region (located next to the spine). Babies in the 3rd group, the bathing group will be fed formula or pumped breast milk, depending on the baby's age and weight. Babies will be bathed under running water 20 minutes after feeding.The bathing process will take 4 minutes in total. After bath, a urine bag will be inserted at the 25th minute of feeding. In all group, urine urination will be monitored by running the stopwatch immediately after the urine bag is placed on all babies. When the baby urinates, the stopwatch will be stopped and the time and success of urination will be recorded on the observation form by the researcher.
- Conditions
- Urine Specimen Collection
- Being tested
- Control, The bladder stimulation technique, Bath
- Keywords
- term babies, urine, bladder stimulation technique, bath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Babies in the control group will be fed only breast milk or formula, and a urine bag will be inserted after 25 minutes and they will be expected to urinate. The success of the transaction and the processing time will be recorded.
The bladder stimulation techniqueOther
Newborns will be fed formula or pumped breast milk, depending on the baby's age and weight. A urine bag will be inserted 25 minutes after the feeding.
The newborn will be held under the armpit by the nurse, male infants will be held with their legs hanging down, and female infants will be held in the hip flexion position.
Newborns with spontaneous voiding during the period from the beginning of the investigation procedure to positioning the newborn will be excluded from the study.
The bladder stimulation technique will be repeated sequentially for 3 minutes until voiding begins.The success of the transaction and the processing time will be recorded.
BathOther
Newborns will be fed formula or pumped breast milk, depending on the baby's age and weight. Babies will be bathed under running water 20 minutes after feeding.The bathing process will take 4 minutes in total. After bath, a urine bag will be inserted at the 25th minute of feeding. The success of the transaction and the processing time will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Babies in the control group will be fed only breast milk or formula, and a urine bag will be inserted after 25 minutes and they will be expected to urinate. The success of the transaction and the processing time will be recorded. Receives: Other: Control |
| The bladder stimulation technique | Experimental | Newborns will be fed formula or pumped breast milk, depending on the baby's age and weight. A urine bag will be inserted 25 minutes after the feeding.
The newborn will be held under the armpit by the nurse, male infants will be held with their legs hanging down, and female infants will be held in the hip flexion position.
Newborns with spontaneous voiding during the period from the beginning of the investigation procedure to positioning the newborn will be excluded from the study.
The bladder stimulation technique will be repeated sequentially for 3 minutes until voiding begins.The success of the transaction and the processing time will be recorded. Receives: Other: The bladder stimulation technique |
| Bath | Experimental | Newborns will be fed formula or pumped breast milk, depending on the baby's age and weight. Babies will be bathed under running water 20 minutes after feeding.The bathing process will take 4 minutes in total. After bath, a urine bag will be inserted at the 25th minute of feeding. The success of the transaction and the processing time will be recorded. Receives: Other: Bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success in Urination
Success in urination is defined as urine sample collection within 3 minutes (180 seconds)
Measured: During the procedure (3 minutes)
Total Urination Time
Total urination time is defined as the time elapsed from the urine collection collector bag placed on the baby to the beginning of the micturition.
Measured: During the procedure (3 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start6 Mar 2024
- Primary completion28 Jul 2024
- Study completion28 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urine Specimen CollectionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Erkut, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188078
- Sponsor's protocol ID
- 2023/01-04
- Status last verified
- Aug 2024
- First submitted
- 13 Dec 2023
- Last updated
- 28 Aug 2024
- 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 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bladder Stimulation Technique and Bathing Method on Urine Collection in Term Babies: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06188078
- Acronym / sponsor ID
- 2023/01-04
- Conditions
- Urine Specimen Collection
- Keywords
- term babies, urine, bladder stimulation technique, bath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 28 Jul 2024 (actual)
- Study completion
- 28 Jul 2024 (actual)
- First posted
- 3 Jan 2024 (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.
Purpose of the Study: The aim of this study is to examine the effect of bladder stimulation technique and bathing method on urine collection in term infants hospitalized in the neonatal intensive care unit.
Content of the Study: This study will consist of 3 groups. Babies in the 1st group, the control group, will be fed only with breast milk or formula, and after 25 minutes, a urine bag will be inserted and urination will be expected. The babies in the second group, the bladder stimulation technique application group, will also be placed in a urine bag 25 minutes after feeding. Then the bladder stimulation technique will be applied. This technique; consists of two consecutive maneuvers. In the first maneuver, the bladder (Urine Bag) is stimulated by hitting the suprapubic (lower parts of the abdomen) area for 30 seconds at a frequency of 100 touches per minute. In the second maneuver, a 30-second circular massage is applied to the paravertebral region (located next to the spine). Babies in the 3rd group, the bathing group will be fed formula or pumped breast milk, depending on the baby's age and weight. Babies will be bathed under running water 20 minutes after feeding.The bathing process will take 4 minutes in total. After bath, a urine bag will be inserted at the 25th minute of feeding. In all group, urine urination will be monitored by running the stopwatch immediately after the urine bag is placed on all babies. When the baby urinates, the stopwatch will be stopped and the time and success of urination will be recorded on the observation form by the researcher.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: ControlBabies in the control group will be fed only breast milk or formula, and a urine bag will be inserted after 25 minutes and they will be expected to urinate. The success of the transaction and the processing time will be recorded. |
| The bladder stimulation technique | Experimental | Other: The bladder stimulation techniqueNewborns will be fed formula or pumped breast milk, depending on the baby's age and weight. A urine bag will be inserted 25 minutes after the feeding. The newborn will be held under the armpit by the nurse, male infants will be held with their legs hanging down, and female infants will be held in the hip flexion position. Newborns with spontaneous voiding during the period from the beginning of the investigation procedure to positioning the newborn will be excluded from the study. The bladder stimulation technique will be repeated sequentially for 3 minutes until voiding begins.The success of the transaction and the processing time will be recorded. |
| Bath | Experimental | Other: BathNewborns will be fed formula or pumped breast milk, depending on the baby's age and weight. Babies will be bathed under running water 20 minutes after feeding.The bathing process will take 4 minutes in total. After bath, a urine bag will be inserted at the 25th minute of feeding. The success of the transaction and the processing time will be recorded. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Term babies whose gestational age is 37+6 days and above,
- Full-term newborns aged 1-28 days
- Orally fed babies
- Babies with stable health status,
- Babies who do not have urological, neurological diseases, or anatomical anomalies that may affect bladder function,
Key exclusion criteria (5 listed)
- Preterm babies whose gestational age is below 37+6 days,
- Babies fed with an orogastric tube (OGS),
- Babies with serious health problems (such as respiratory distress),
- Babies with urological, neurological diseases or anatomical anomalies that may affect bladder function,
- Babies of parents who do not agree to participate in the study will be excluded from 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlBabies in the control group will be fed only breast milk or formula, and a urine bag will be inserted after 25 minutes and they will be expected to urinate. The success of the transaction and the processing time will be recorded. | Other | Control |
| The bladder stimulation techniqueNewborns will be fed formula or pumped breast milk, depending on the baby's age and weight. A urine bag will be inserted 25 minutes after the feeding. The newborn will be held under the armpit by the nurse, male infants will be held with their legs hanging down, and female infants will be held in the hip flexion position. Newborns with spontaneous voiding during the period from the beginning of the investigation procedure to positioning the newborn will be excluded from the study. The bladder stimulation technique will be repeated sequentially for 3 minutes until voiding begins.The success of the transaction and the processing time will be recorded. | Other | The bladder stimulation technique |
| BathNewborns will be fed formula or pumped breast milk, depending on the baby's age and weight. Babies will be bathed under running water 20 minutes after feeding.The bathing process will take 4 minutes in total. After bath, a urine bag will be inserted at the 25th minute of feeding. The success of the transaction and the processing time will be recorded. | Other | Bath |
Primary outcome
Success in Urination
Time frame: During the procedure (3 minutes)
Success in urination is defined as urine sample collection within 3 minutes (180 seconds)
Total Urination Time
Time frame: During the procedure (3 minutes)
Total urination time is defined as the time elapsed from the urine collection collector bag placed on the baby to the beginning of the micturition.
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 28 Aug 2024.
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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 The bladder stimulation technique and Bath in people with Urine Specimen Collection, run by Maltepe 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 6 inclusion and 5 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 28 Aug 2024. 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?
Success in Urination (time frame: During the procedure (3 minutes)). The study lists 2 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 28 Aug 2024; AzTrials last refreshed its copy on 29 Oct 2026.