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临床试验/NCT06944054
NCT06944054已完成不适用

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

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Neonatal Skin Condition Assessment Scale (NSCS)

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

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.

入排标准

年龄范围
37 Weeks 至 40 Weeks(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Group 1 (Other)

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.

结局指标

主要结局

Neonatal Skin Condition Assessment Scale (NSCS)

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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