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Evaluation of the Effect of Duration of Stabilising Tapes on Skin Damage in Neonates

Evaluation of the Effect of the Time the Stabilizer Tapes Stay on the Skin on Skin Damage in Newborns

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06944054
Enrollment
60
Registered
2025-04-25
Start date
2023-08-01
Completion date
2023-11-01
Last updated
2025-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborns

Keywords

Skin Damage, Epidermis, Stabilization Tapes, Newborn

Brief 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.

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

Interventions

OTHERGroup 1

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.

Sponsors

Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
CollaboratorOTHER
Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

In the study, participant and researcher blinding could not be performed because the researcher was involved in the application and the method applied to the parents of the participants was explained verbally.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
37 Weeks to 40 Weeks
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Neonatal Skin Condition Assessment Scale (NSCS)3 daysThe 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 Scale3 daysThese 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026