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

NCT ID: NCT06944054

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2023-11-01

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

Conditions

Newborns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

2 hourly interval stabiliser band change group

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.

Group Type: EXPERIMENTAL

Group 1

Intervention Type: 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.

4 hourly interval stabiliser band change group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 37 Weeks
• Maximum Eligible Age: 40 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sağlik Bilimleri Üniversitesi

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SBU-HF-KK-01

Identifier Type: -

Identifier Source: org_study_id