NewbornsNCT06944054
Evaluation of the Effect of Duration of Stabilising Tapes on Skin Damage in Neonates
A study testing Group 1 in people with Newborns, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The research was conducted to evaluate the relationship between the duration of the fixing tapes of the probes attached to the chest, abdominal and lower extremity regions of newborns for temperature monitoring and skin damage. Read more about this study
- Who is it for?
- Ages 37 to 40 weeks
- Conditions the study is for
- Newborns
- What is being tested?
- Group 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Nov 2023
- 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
- No healthy volunteers
- Child
Who may be able to join
- Newborns between 37th and 40th week
- Use of a temperature monitoring probe
- Parents volunteering their infants to participate in the study and signing the consent form
Who cannot join
- Presence of conditions that may make skin condition assessment difficult (presence of any laceration, fracture or genetic dermatological disease that disrupts skin integrity, congenital skin damage, hydrops, anomalies of the anterior abdominal wall, scleroderma)
- Parents not volunteering for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of the Time the Stabilizer Tapes Stay on the Skin on Skin Damage in Newborns
The research was conducted to evaluate the relationship between the duration of the fixing tapes of the probes attached to the chest, abdominal and lower extremity regions of newborns for temperature monitoring and skin damage.
Read the detailed description
Aim: The research was conducted to evaluate the relationship between the duration of the fixing tapes of the probes attached to the chest, abdominal and lower extremity regions of newborns for temperature monitoring and skin damage.
Materials and Methods: The research was conducted in a randomized controlled experimental design between August 2023 and December 2023. The 37th-40th year is being treated in the Neonatal Intensive Care Unit of Gynecology Training and Research Hospital. It was done with 60 newborns between weeks. Newborns were assigned to the experimental group (n = 30) and control group (n = 30) by simple randomization. In the experimental group, the duration of the fixative tapes to stay on the skin was 2 hours, and in the control group, the duration of the fixative tapes to stay on the skin was 4 hours, which is applied in the clinical routine. Stabilizer tapes were adhered to three different areas on the skin and changed clockwise. Data were collected using the Newborn Information Form, Newborn Skin Condition Assessment Scale (NSCS) and Newborn Skin Risk Assessment Scale (NSRAS). Descriptive statistics, repeated measures ANOVA, Pearson Correlation test and Pearson Chi Square test statistics were used in data analysis. p<0.05 level was considered statistically significant.
Key Words: Newborn, Skin Damage, Epidermis, Stabilization Tapes, Newborn Nurse
- Conditions
- Newborns
- Being tested
- Group 1
- Keywords
- Skin Damage, Epidermis, Stabilization Tapes, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Other
Every 2 hours, the heat probes were replaced. Hypoallergenic patches were removed with a silicone-based spray used in the clinic. The application continued for 24 hours. In total, 12 heat probe displacements were made to different points in the abdominal, chest or lower extremity region. Heat probe stabilising tapes were attached to different points in a clockwise direction. At the end of 24 hours, the skin conditions of the newborns were re-evaluated with scales and recorded. This application continued for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| 2 hourly interval stabiliser band change group | Experimental | Every 2 hours, the heat probes were replaced. Hypoallergenic patches were removed with a silicone-based spray used in the clinic. The application continued for 24 hours. In total, 12 heat probe displacements were made to different points in the abdominal, chest or lower extremity region. Heat probe stabilising tapes were attached to different points in a clockwise direction. At the end of 24 hours, the skin conditions of the newborns were re-evaluated with scales and recorded. This application continued for 3 days. Receives: Other: Group 1 |
| 4 hourly interval stabiliser band change group | No intervention | Hypoallergenic patches were removed with a silicone-based spray used in the clinic. The application continued for 24 hours. A total of 6 heat probe displacements were applied to different points in the abdomen, chest or lower extremities at 4-hour intervals. Heat probe fixation bands were attached clockwise to different points. At the end of 24 hours, the skin condition of the newborns was evaluated with scales. This application continued for 3 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Skin Condition Assessment Scale (NSCS)
The NSCS is a 3-point Likert-type scale that evaluates dryness, redness, peeling and deterioration of the skin. Evaluation of the scale score: each criterion was scored with 1 being the best and 3 being the worst. A maximum of 9 and a minimum of 3 points can be scored in the total score. A score of 9 indicates a poor skin score, while a score of 3 indicates a good skin score. An increase in the scale score means that the skin condition is poor.
Measured: 3 days
Neonatal Skin Risk Assessment Scale
These are general physical condition, mental state, mobility, activity, nutrition, humidity. Each parameter in the scale is scored from 1 to 4. The score that can be obtained from the scale varies between 6 and 24. A high score on the scale indicates an increased risk of skin integrity disruption in the newborn, while a low score means that the risk of skin integrity disruption is low. was used.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Aug 2023
- Primary completion1 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornsStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were divided into experimental and control groups. In the experimental group, the fixative tapes were changed every 2 hours, and in the control group, the clinical routine was applied and changed every 4 hours.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944054
- Sponsor's protocol ID
- SBU-HF-KK-01
- Status last verified
- Dec 2024
- First submitted
- 13 Jan 2025
- Last updated
- 25 Apr 2025
- 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 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the Time the Stabilizer Tapes Stay on the Skin on Skin Damage in Newborns
- ClinicalTrials.gov ID
- NCT06944054
- Acronym / sponsor ID
- SBU-HF-KK-01
- Conditions
- Newborns
- Keywords
- Skin Damage, Epidermis, Stabilization Tapes, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 25 Apr 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 research was conducted to evaluate the relationship between the duration of the fixing tapes of the probes attached to the chest, abdominal and lower extremity regions of newborns for temperature monitoring and skin damage.
Detailed description
Aim: The research was conducted to evaluate the relationship between the duration of the fixing tapes of the probes attached to the chest, abdominal and lower extremity regions of newborns for temperature monitoring and skin damage.
Materials and Methods: The research was conducted in a randomized controlled experimental design between August 2023 and December 2023. The 37th-40th year is being treated in the Neonatal Intensive Care Unit of Gynecology Training and Research Hospital. It was done with 60 newborns between weeks. Newborns were assigned to the experimental group (n = 30) and control group (n = 30) by simple randomization. In the experimental group, the duration of the fixative tapes to stay on the skin was 2 hours, and in the control group, the duration of the fixative tapes to stay on the skin was 4 hours, which is applied in the clinical routine. Stabilizer tapes were adhered to three different areas on the skin and changed clockwise. Data were collected using the Newborn Information Form, Newborn Skin Condition Assessment Scale (NSCS) and Newborn Skin Risk Assessment Scale (NSRAS). Descriptive statistics, repeated measures ANOVA, Pearson Correlation test and Pearson Chi Square test statistics were used in data analysis. p<0.05 level was considered statistically significant.
Key Words: Newborn, Skin Damage, Epidermis, Stabilization Tapes, Newborn Nurse
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were divided into experimental and control groups. In the experimental group, the fixative tapes were changed every 2 hours, and in the control group, the clinical routine was applied and changed every 4 hours.
| Arm | Type | Receives |
|---|---|---|
| 2 hourly interval stabiliser band change group | Experimental | Other: Group 1Every 2 hours, the heat probes were replaced. Hypoallergenic patches were removed with a silicone-based spray used in the clinic. The application continued for 24 hours. In total, 12 heat probe displacements were made to different points in the abdominal, chest or lower extremity region. Heat probe stabilising tapes were attached to different points in a clockwise direction. At the end of 24 hours, the skin conditions of the newborns were re-evaluated with scales and recorded. This application continued for 3 days. |
| 4 hourly interval stabiliser band change group | No intervention | –Hypoallergenic patches were removed with a silicone-based spray used in the clinic. The application continued for 24 hours. A total of 6 heat probe displacements were applied to different points in the abdomen, chest or lower extremities at 4-hour intervals. Heat probe fixation bands were attached clockwise to different points. At the end of 24 hours, the skin condition of the newborns was evaluated with scales. This application continued for 3 days. |
Who may qualify
- Ages
- 37 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborns between 37th and 40th week
- Use of a temperature monitoring probe
- Parents volunteering their infants to participate in the study and signing the consent form
Key exclusion criteria (2 listed)
- Presence of conditions that may make skin condition assessment difficult (presence of any laceration, fracture or genetic dermatological disease that disrupts skin integrity, congenital skin damage, hydrops, anomalies of the anterior abdominal wall, scleroderma)
- Parents not volunteering for 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 |
|---|---|---|
| Group 1Every 2 hours, the heat probes were replaced. Hypoallergenic patches were removed with a silicone-based spray used in the clinic. The application continued for 24 hours. In total, 12 heat probe displacements were made to different points in the abdominal, chest or lower extremity region. Heat probe stabilising tapes were attached to different points in a clockwise direction. At the end of 24 hours, the skin conditions of the newborns were re-evaluated with scales and recorded. This application continued for 3 days. | Other | 2 hourly interval stabiliser band change group |
Primary outcome
Neonatal Skin Condition Assessment Scale (NSCS)
Time frame: 3 days
The NSCS is a 3-point Likert-type scale that evaluates dryness, redness, peeling and deterioration of the skin. Evaluation of the scale score: each criterion was scored with 1 being the best and 3 being the worst. A maximum of 9 and a minimum of 3 points can be scored in the total score. A score of 9 indicates a poor skin score, while a score of 3 indicates a good skin score. An increase in the scale score means that the skin condition is poor.
Neonatal Skin Risk Assessment Scale
Time frame: 3 days
These are general physical condition, mental state, mobility, activity, nutrition, humidity. Each parameter in the scale is scored from 1 to 4. The score that can be obtained from the scale varies between 6 and 24. A high score on the scale indicates an increased risk of skin integrity disruption in the newborn, while a low score means that the risk of skin integrity disruption is low. was used.
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 25 Apr 2025.
- 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 Group 1 in people with Newborns, run by Saglik Bilimleri Universitesi 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: finished, as of the sponsor's last update on 25 Apr 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?
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?
Neonatal Skin Condition Assessment Scale (NSCS) (time frame: 3 days). 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 25 Apr 2025.