AzTrials
AzTrials

Pressure Injury PreventionNCT06369844

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

A study testing Pressure injury education in people with Pressure Injury Prevention, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pressure Injury Prevention
What is being tested?
Pressure injury education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2024to 22 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara yıldırım Beyazıt Üniversitesi

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: 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?
Read more

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.
Read the 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.

Being tested
Pressure injury education
Keywords
pressure injuries, pediatric, nurses knowledge
Medical subject headings
Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pressure injury educationOther

    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.

Study groups in NCT06369844
Study groupRoleWhat they receive
Intervention groupExperimentalThe group that received pediatric pressure injury education
Receives: Other: Pressure injury education
Control groupNo interventionThe group that did not receive pediatric pressure injury education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stop Pressure Injuries" Education Evaluation Survey

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2024
  2. Study start1 Apr 2024
  3. Primary completion1 May 2024
  4. Study completion22 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study design will be two-group and pretest-posttest design.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06369844
Sponsor's protocol ID
1.2023-440
Status last verified
Jul 2024
First submitted
9 Apr 2024
Last updated
5 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: NAME, SURNAME , EMAIL ADDRESS

Publications

  • undefined

  • Triantafyllou C, Chorianopoulou E, Kourkouni E, Zaoutis TE, Kourlaba G. Prevalence, incidence, length of stay and cost of healthcare-acquired pressure ulcers in pediatric populations: A systematic review and meta-analysis. Int J Nurs Stud. 2021 Mar;115:103843. doi: 10.1016/j.ijnurstu.2020.103843. Epub 2020 Dec 16.

    PubMed 33373805
  • Lyren A, Brilli R, Bird M, Lashutka N, Muething S. Ohio Children's Hospitals' Solutions for Patient Safety: A Framework for Pediatric Patient Safety Improvement. J Healthc Qual. 2016 Jul-Aug;38(4):213-22. doi: 10.1111/jhq.12058.

    PubMed 26042749
  • Li Z, Lin F, Thalib L, Chaboyer W. Global prevalence and incidence of pressure injuries in hospitalised adult patients: A systematic review and meta-analysis. Int J Nurs Stud. 2020 May;105:103546. doi: 10.1016/j.ijnurstu.2020.103546. Epub 2020 Jan 31.

    PubMed 32113142
  • 1. European Pressure Ulcer Asvisory Panel, National Pressure Injury Panel, Pan Pacific Injury Alliance . (2019). Prevention and Treatment of Pressure Ulcers/İnjuries: Clinical Practice Guideline. The İnternational Guideline.

Questions about this trial

What is this clinical trial studying?

A study testing Pressure injury education in people with Pressure Injury Prevention, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06369844, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in