Pressure Injury Education Intervention for Pediatric Intensive Care Nurses: A Randomized Controlled Trial

April 12, 2024 updated by: Neşe ÖZYURT, Ankara Yildirim Beyazıt University

The Impact of 'Stop Pressure Injury' Education for Pediatric Patients on Nurses' Knowledge Level and the Probability of Pediatric Pressure Injury Occurrence

The purpose of this observational study is to find out the impact of pressure injury education on the knowledge level of pediatric intensive care nurses and the likelihood of pediatric pressure injury occurrence. The main questions it aims to answer are:

  • Does pressure injury education increase nurses knowledge level on pediatric pressure injuries?
  • Does the rate of pediatric pressure injuries decrease after the education?

The researcher will compare nurses working in two separate pediatric intensive care units where similar patients are treated to see if planned education on pressure injuries affects nurses knowledge level and the rate of pediatric pressure injuries.

  • Volunteer nurses participating in the study will answer pressure injury survey questions prepared by the researcher.
  • Nurses in the intervention group will attend planned education sessions provided by the researcher.
  • Two weeks after the completion of the education sessions, all nurses in the intervention and control groups who wish to continue participating in the study will answer the pressure injury survey questions prepared by the researcher again.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Children with critical illness in intensive care units are a high-risk group for pressure injuries due to immobility and intensive medical device use (Setchell et al., 2023). The study will be conducted with nurses working in third-level pediatric intensive care units within a city hospital in Ankara. There are five pediatric intensive care units in the hospital: a 16-bed Pediatric Surgical Intensive Care Unit, a 16-bed Pediatric Cardiovascular Surgery Intensive Care Unit, a 12-bed Pediatric Intensive Care Unit, and another 12-bed Pediatric Intensive Care Unit. The number of nurses working in these intensive care units is 25, 20, 28, and 29, respectively. These 102 nurses constitute the population of the study. Firstly, the sample size was determined. G-power 3.1.9.4 analysis program was used to determine the sample size. Considering a similar study on the topic, the sample size was calculated (Karimian et al., 2020). The effect size was calculated as 1.23 in the reference study. According to this effect size, considering a 5% error rate (α) and 95% power (1-β), it was determined that there should be a total of 38 participants in the study, with 19 in the intervention group and 19 in the control group. However, assuming possible losses in the sample, the sample size was increased by 30%, resulting in 25 participants in the intervention group and 25 in the control group (n1: 25 - n2: 25). Then, considering the sample size, the pediatric intensive care units where nurses would participate in the sampling were determined. Three-month pressure injury rates of these intensive care units were obtained from the hospital's quality unit to determine these units. According to these rates, these intensive care units were ranked. The first two ranks were taken by the Pediatric Intensive Care Units. To prevent the intervention and control groups from influencing each other, one of the intensive care units was designated as the intervention group and the other as the control group. During the assignment, these intensive care units were given names A and B by a person unrelated to the study. The intervention and control groups were determined by a lottery method. There are enough nurses in the relevant intensive care units to meet the determined sample size of the study. After determining the sample size of the study, the training dates were planned. The principal investigator of the study is also the pediatric wound care nurse at the hospital. As of the planned training date, service supervisors and the researcher made two calls for pre-test participation in both the intervention and control groups. Each of the intensive care units involved in the study has 12 beds and provides care to two patients per nurse. There are 8 nurses working in shifts of 08-08 hours per day. Pre-test data collection is planned for 3 days without disrupting the operation of the intensive care units. After the pre-test data collection, a pressure injury training consisting of 3 sessions lasting 40 minutes each will be provided to the intervention group for 1 week without disrupting patient care. Although the intensive care units are on separate floors in the hospital, the nurses are separate, but the patient profiles are similar. Two weeks after the completion of the training, post-test data will be collected in a similar manner. The training will cover pressure injury definition and classification, risk factors and assessment scales for pressure injuries in children, and pressure injury prevention and care. The collected data will be analyzed and interpreted using statistical methods. Pressure injury rates in the intensive care units will be compared again after the training. The questionnaire used to measure the nurses' knowledge levels and the training were created by the principal investigator. The created training and questionnaire were sent to 10 expert doctors who are specialists in their respective fields for expert opinion. The results of the expert opinions were statistically analyzed. The Cronbach's Alpha Internal Consistency Coefficient for the questionnaire used for pre-test and post-test was calculated as a total of 0.977, which is considered highly reliable.The training content has also been found to be at a very appropriate level.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara yıldırım Beyazıt Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Working in pediatric intensive care for more than 6 months
  • Having provided pressure injury care at least once
  • Voluntarily agreeing to participate in the study
  • Working in intensive care where pressure injuries are commonly seen.

Exclusion Criteria:

  • Having wound care certification
  • Not attending all of the training sessions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
The group that received pediatric pressure injury education
Other: Pressure injury education
Pressure injury education will be provided to participants in the intervention group in three separate sessions covering the topics of Pressure Injury Definition and Classification, Risk Assessment, Prevention, and Care.
No Intervention: Control group
The group that did not receive pediatric pressure injury education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stop Pressure Injuries" Education Evaluation Survey
Time Frame: he questionnaires prepared by the researcher will be answered by both groups immediately before the training for pre-test results and two weeks after the training.
The survey consists of subheadings: Pressure Injury Definition and Classification, Risk Assessment, Prevention, and Care. The survey comprises a total of 50 true/false statements. Participants will mark the statements as true or false. They will receive 1 point for correct answers and 0 points for incorrect answers. The total score of the survey is 50.
he questionnaires prepared by the researcher will be answered by both groups immediately before the training for pre-test results and two weeks after the training.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Yildirim Beyazıt University

Collaborators

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Neşe Özyurt, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

April 3, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.2023-440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NAME, SURNAME , EMAIL ADDRESS

IPD Sharing Time Frame

April 2024- April 2025

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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