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

NCT06944054 | Completed

• 1 other identifier: SBU-HF-KK-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborns

Keywords

Skin Damage; Epidermis; Stabilization Tapes; Newborn

Outcome Measures

Primary Outcomes (2)

• Neonatal Skin Condition Assessment Scale (NSCS)

  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.

  3 days

• Neonatal Skin Risk Assessment Scale

  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.

  3 days

Study Arms (2)

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.

Other: Group 1

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.

Interventions

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.

2 hourly interval stabiliser band change group

Eligibility Criteria

• Age: 37 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital: collaborator

Study Sites (1)

Sağlik Bilimleri Üniversitesi

Ankara, 06010, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: April 25, 2025
• Study Start: August 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 25, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)