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Completed

NCT Number: NCT06944054

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

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.

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Key information

Conditions

Age range

37 week–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sağlik Bilimleri Üniversitesi

Ankara, 06010, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group 1

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Collaborators

  • Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2025
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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