The Effect of Replacement Frequency of Electrodes on Skin in Infant

Sponsor

Acibadem University (Other)

Overall Status

Completed

CT.gov ID

NCT05016167

Collaborator

(none)

Enrollment

Location

Arms

9.5

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Premature	Procedure: Replacement every 24 hours Procedure: Replacement every 12 hours	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Replacement Frequency of Electrodes on Skin Moisture and Condition in Infants Hospitalized in the Pediatric Intensive Care Unit

Actual Study Start Date :

Aug 31, 2018

Actual Primary Completion Date :

Jun 17, 2019

Actual Study Completion Date :

Jun 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Control group (replacement every 24 hours) The monitoring electrodes were not replaced for 24 hours, the electrodes were removed at the end of 24 hours (the protocol currently used in the institution) in control group.	Procedure: Replacement every 24 hours Processing Steps: The monitoring electrodes were not replaced for 24 hours, the electrodes were removed at the end of 24 hours. During the 24-hour follow-up, patients whose electrodes were removed for any reason were excluded from the sample. Immediately after the drying, skin moisture measurement was made in the right 2nd intercostal space (ICA), left 2nd ICA, and midclavicular 5th ICA regions. The skin condition was evaluated from the areas monitored using the skin condition score by the researcher and another independent observer. The data were recorded.
Experimental: Experimental Group (replacement every 12 hours) In the experimental group, the monitoring electrodes were replacement every 12 hours within 24 hours.	Procedure: Replacement every 12 hours Processing Steps: Monitoring electrodes were removed at the end of the 12th hour. When removing the monitoring electrodes, the area was first wetted using a disinfectant and dried using a sponge after removing the electrodes. Immediately after the drying, skin moisture measurement was made in the right 2nd ICA, left 2nd ICA and midclavicular 5th ICA regions. The skin condition was evaluated from these areas monitored using the skin condition score by the researcher and another independent observer. Monitored again. Monitoring electrodes were removed at the end of the 24th hour. Cleaning and drying were done immediately after removal. Immediately after drying, skin moisture was measured from the monitored areas. The skin condition was evaluated from the areas monitored using the skin condition score by the researcher and another independent observer. The data were recorded.

Arm

Intervention/Treatment

Other: Control group (replacement every 24 hours)

The monitoring electrodes were not replaced for 24 hours, the electrodes were removed at the end of 24 hours (the protocol currently used in the institution) in control group.

Procedure: Replacement every 24 hours

Processing Steps: The monitoring electrodes were not replaced for 24 hours, the electrodes were removed at the end of 24 hours. During the 24-hour follow-up, patients whose electrodes were removed for any reason were excluded from the sample. Immediately after the drying, skin moisture measurement was made in the right 2nd intercostal space (ICA), left 2nd ICA, and midclavicular 5th ICA regions. The skin condition was evaluated from the areas monitored using the skin condition score by the researcher and another independent observer. The data were recorded.

Experimental: Experimental Group (replacement every 12 hours)

In the experimental group, the monitoring electrodes were replacement every 12 hours within 24 hours.

Procedure: Replacement every 12 hours

Processing Steps: Monitoring electrodes were removed at the end of the 12th hour. When removing the monitoring electrodes, the area was first wetted using a disinfectant and dried using a sponge after removing the electrodes. Immediately after the drying, skin moisture measurement was made in the right 2nd ICA, left 2nd ICA and midclavicular 5th ICA regions. The skin condition was evaluated from these areas monitored using the skin condition score by the researcher and another independent observer. Monitored again. Monitoring electrodes were removed at the end of the 24th hour. Cleaning and drying were done immediately after removal. Immediately after drying, skin moisture was measured from the monitored areas. The skin condition was evaluated from the areas monitored using the skin condition score by the researcher and another independent observer. The data were recorded.

Outcome Measures

Primary Outcome Measures

Change in skin moisture [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.]
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%). As the moisture in the skin increases, the % increases. Skin moisture measurement was made in the right 2nd ICA, left 2nd ICA, and midclavicular 5th ICA regions.
Change in skin condition [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.]
Skin condition were evaluated with the Skin Condition Assessment Scale. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 12 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acıbadem University Atakent Hospital	Istanbul		Turkey

Sponsors and Collaborators

Acibadem University

Investigators

Principal Investigator: Zehra Kan Onturk, Assist Prof, Acibadem University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zehra Kan Onturk, Assist. Prof., Acibadem University

ClinicalTrials.gov Identifier:

NCT05016167

Other Study ID Numbers:

ATADEK-2018/11

First Posted:

Aug 23, 2021

Last Update Posted:

Oct 26, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zehra Kan Onturk, Assist. Prof., Acibadem University

Infant

Moisture

Monitoring

Pediatric Intensive Care

Skin

Study Results

No Results Posted as of Oct 26, 2021