Clinical trial NCT05016167: The Effect of Replacement Frequency of Electrodes on Skin in Infant
Official title: The Effect of Replacement Frequency of Electrodes on Skin Moisture and Condition in Infants Hospitalized in the Pediatric Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Keywords: Infant
Moisture
Monitoring
Pediatric Intensive Care
Skin
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 33
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In the Pediatric Intensive Care Unit (PICU), each child and infant is monitored to determine the status of the underlying disease by constantly monitoring the main variables, to help diagnosis and to guide treatment. During the monitoring application, electrodes of appropriate size for the patient's age and body surface are attached to the appropriate areas of the patient where skin integrity is intact, clean, and dry. It is recommended that these electrodes be replaced within 24 hours at most, but there is no evidence of the effect of electrode replacement frequency on skin moisture and integrity.

Based on this reason, this study was conducted experimentally in a randomized controlled manner to determine the effect of frequency of monitoring electrode replacement on skin moisture and condition of infants hospitalized in the PICU.

Detailed description: The study was conducted with 66 participants, with the number of participants being 33 in both two groups (Experimental and Control Group).The randomization of the sample was determined by entering the total number of cases in line with the Research Randomizer program.

The control group of the study involved infants whose monitoring electrodes were replaced at the 24th hour after being monitored and the experimental group involved infants whose monitoring electrodes were replaced at the 12th and 24th hour after being monitored.

Before all participants are monitored, skin cleansing was performed on the right second intercostal space (Right 2nd ICA), left second intercostal space (Left 2nd ICA) and the left lower side of the sternum at the left midclavicular level in the fifth intercostal space (Midclavicular 5th ICA). After that, skin moisture was measured where monitoring will be performed and skin condition evaluation of these areas. Then the participants were monitored.

After these applications, skin moisture and skin condition score evaluations were repeated in both groups.

Skin Condition Score The skin condition score, developed by the Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) and validated by Calisir et al. in 2016, was used to determine the skin condition. The scale consists of three items and each item includes an evaluation criterion. These are dryness, erythema, and skin integrity breakdown/peeling, respectively. Each item of the 3-point Likert scale gets 1 to 3 points. The lowest score that can be obtained from the scale is 3, the highest score is 9. A high total score indicates that the skin condition of the newborn is poor. Permission was obtained for the use of the skin condition score from the Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) and the authors who performed the Turkish validity and reliability.

Skin Moisture Digital Moisture Monitor For Skin was used to measure skin moisture. This moisture measuring device measures with "%". This device developed for precise measurement has been preferred because of its ability to show the amount of moisture by the contact without damaging the skin, being portable, working with a battery, having a wide measurement range (it can measure the amount of skin moisture from 0% to 99.9%), because of its fast, easy and reliable use, low cost, and its ability to measure in many anatomical regions.

Materials provided in accordance with the procurement procedure of the institution where the research was conducted and used in patient care during the data collection phase were preferred as consumable materials.

Researchers do not have any conflict of interest with companies regarding the preference of these materials. The consumables that are still used in the institution.

Eligibility criteria: Inclusion Criteria:

* Patients whose parents agreed to participate in the study and signed the informed consent form
* No history of surgical procedures
* Recently admitted to the unit and monitored for the first time
* Infants aged ≥ 1 to 12 ≤ months

Exclusion Criteria:

* Infants with a skin disease, with other diseases that can affect skin moisture and condition, with immune system disease

Primary outcomes:
measure: Change in skin moisture
timeFrame: Data collected immediately before monitoring, after monitoring 12th hour (only for experimental group) and after 24 th hours. The change in these time intervals assessed.
measure: Change in skin condition
timeFrame: Data collected immediately before monitoring, after monitoring 12th hour (only for experimental group) and after 24 th hours. The change in these time intervals assessed.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem University Atakent Hospital
Study officials:
affiliation: Acibadem University
name: Zehra Kan Onturk, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Jackson D, Sarki AM, Betteridge R, Brooke J. Medical device-related pressure ulcers: A systematic review and meta-analysis. Int J Nurs Stud. 2019 Apr;92:109-120. doi: 10.1016/j.ijnurstu.2019.02.006. Epub 2019 Feb 10.