The Effect of Care Bundle in Preventing Pressure Ulcers Caused by Medical Devices in the Pediatric Intensive Care Unit

NCT ID: NCT05406986

Last Updated: 2022-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2022-10-15

Brief Summary

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With the development of technology in medicine, more medical instruments are used in the treatment of diseases. Although the use of these instruments provides great benefits for the patients, it can also cause some complications.One of the most important of these complications is pressure ulcer.Some care and evaluation are needed to prevent these complications.This study aims to prevent pressure ulcers with a care package for patients with high risk scores.

Detailed Description

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A care package will be created with the Delphi method to prevent pressure ulcers caused by medical devices.Experimental and control groups will be formed by randomized control method.The care package created for 14 days will be applied to the experimental group. standard care will be applied to the control group.As a result, the rates of medical device-induced pressure ulcers in both groups will be compared.Children between the ages of 1 and 10 years and treated in the pediatric intensive care unit will be included in the study.Patients with any skin-related disease will not be included in the study.

Conditions

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Pressure Ulcer Nursing Caries Device Induced Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental and control groups will be selected using the randomized control method.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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the group to which the care bundle will be applied

Patients with a score of 13 or higher on the Braden QD medical instrument risk assessment scale.

Patients with attached nasogastric tube, intubation tube and saturation probe.

Group Type EXPERIMENTAL

care bundle application

Intervention Type OTHER

The patients in the experimental group will be given care according to the current care bundle for 14 days

group not to be interfered with

Patients with attached nasogastric tube, intubation tube and saturation probe.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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care bundle application

The patients in the experimental group will be given care according to the current care bundle for 14 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* being in the pediatric intensive care unit.
* nasogastric tube, intubation tube and saturation probe attached.
* Voluntary consent of family to participate in the study

Exclusion Criteria

* Patients with skin disease
* Patients staying less than 14 days
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kilis 7 Aralik University

OTHER

Sponsor Role lead

Responsible Party

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Erhan Elmaoğlu

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zerrin Çiğdem

Role: PRINCIPAL_INVESTIGATOR

Hasan Kalyoncu Univesity

Central Contacts

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Erhan Elmaoğlu

Role: CONTACT

+903488142666

References

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Butler CT. Pediatric skin care: guidelines for assessment, prevention, and treatment. Dermatol Nurs. 2007 Oct;19(5):471-2, 477-82, 485.

Reference Type RESULT
PMID: 18286861 (View on PubMed)

Curley MAQ, Hasbani NR, Quigley SM, Stellar JJ, Pasek TA, Shelley SS, Kulik LA, Chamblee TB, Dilloway MA, Caillouette CN, McCabe MA, Wypij D. Predicting Pressure Injury Risk in Pediatric Patients: The Braden QD Scale. J Pediatr. 2018 Jan;192:189-195.e2. doi: 10.1016/j.jpeds.2017.09.045.

Reference Type RESULT
PMID: 29246340 (View on PubMed)

Freundlich K. Pressure Injuries in Medically Complex Children: A Review. Children (Basel). 2017 Apr 7;4(4):25. doi: 10.3390/children4040025.

Reference Type RESULT
PMID: 28387749 (View on PubMed)

Puspitasari JD, Nurhaeni N, Waluyanti FT. Testing of Braden QD Scale for predicting pressure ulcer risk in the Pediatric Intensive Care Unit. Pediatr Rep. 2020 Jun 25;12(Suppl 1):8694. doi: 10.4081/pr.2020.8694. eCollection 2020 Jun 25.

Reference Type RESULT
PMID: 32904968 (View on PubMed)

Delmore BA, Ayello EA. CE: Pressure Injuries Caused by Medical Devices and Other Objects: A Clinical Update. Am J Nurs. 2017 Dec;117(12):36-45. doi: 10.1097/01.NAJ.0000527460.93222.31.

Reference Type RESULT
PMID: 29120893 (View on PubMed)

Other Identifiers

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Kilis7AralikUnivesity2022

Identifier Type: -

Identifier Source: org_study_id

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