Clinical trial NCT06944054: Evaluation of the Effect of Duration of Stabilising Tapes on Skin Damage in Neonates
Official title: Evaluation of the Effect of the Time the Stabilizer Tapes Stay on the Skin on Skin Damage in Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborns
Keywords: Skin Damage
Epidermis
Stabilization Tapes
Newborn
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
Collaborators: name: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
First posted: 2025-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 37
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Neonatal Skin Condition Assessment Scale (NSCS)
timeFrame: 3 days
measure: Neonatal Skin Risk Assessment Scale
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Sağlik Bilimleri Üniversitesi
Study officials:
References: