NCT05661214

Brief Summary

The goal of this randomized controlled study is to compare the changes in cognitive, attitudinal and psychomotor domains for pressure injury between nursing students who take model-based structured pressure injury risk management teaching by examining risk factors and plan nursing interventions through sample cases with Clinical Decision Support System (CDSS) integrated software, and nursing students who plan nursing interventions through sample cases on the software by receiving standard teaching. The hypothesis are: H1: The knowledge of the students who received the model-based structured pressure injury risk management teaching with the CDSS integrated method is different from the control group who received the standard training. H1a: The attitudes of the students who received the model-based structured pressure injury risk management instruction with the CDSS integrated method to prevent injuries are different from the control group who received the standard training. H1b: The nursing interventions planned by the students who received the model-based structured pressure injury risk management education with the CDSS integrated method are different from the control group who received the standard education.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

October 2, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2024

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

December 5, 2022

Last Update Submit

February 14, 2023

Conditions

Keywords

pressure injury risk managementnursing studentrandomized controlled trial

Outcome Measures

Primary Outcomes (3)

  • Knowledge levels of nursing students about pressure injury

    The first data, will be obtained with the valid and reliable instrument before teaching period (pre-test). After applying the instrument, researchers will teach the nursing students for five weeks. After, the teaching process is over, researchers will apply the same instrument (post-test) to obtain the data of knowledge. The aim is to determine the rate of change in the knowledge levels of nursing students before and after the education.

    2.5 months (10 weeks)

  • Attitudes of nursing students about pressure injury

    The first data, will be obtained with the valid and reliable instrument before teaching period (pre-test). After applying the instrument, researchers will teach the nursing students for five weeks. After, the teaching process is over, researchers will apply the same instrument (post-test) to obtain the data of attitude. The aim is to determine the rate of change about the attitudes of nursing students before and after the education.

    2.5 months (10 weeks)

  • Psychomotor development of nursing students about pressure injury

    The first data, will be obtained with the case and nursing care plan before teaching period (pre-test). After applying the instrument, researchers will teach the nursing students for five weeks. After, the teaching process is over, researchers will apply the same case and nursing care plan (post-test) to obtain the data of psychomotor development. The aim is to determine the rate of change about the psychomotor development of nursing students before and after the education.

    2.5 months (10 weeks)

Study Arms (4)

Control Group 1

NO INTERVENTION

This group is the control group 1 (one) that will be taught using structured standard teaching content. Before teaching, participants will be applied pre tests. After teaching, they will be applied post tests.

Intervention Group 1

EXPERIMENTAL

This group is the intervention group 1 (one) that will be taught using model-based structured teaching content. In this teaching content, researchers will teach pressure injury risk factors; after teaching, participants will plan nursing interventions with Clinical Decision Support System (CDSS) integrated software. Before teaching, participants will be applied pre tests. After teaching, they will be applied post tests.

Other: Teaching

Control Group 2

NO INTERVENTION

This group is the control group 2 (two) that will be taught using structured standard teaching content. After teaching, they will be applied post tests. This group has no pre-test and will be created to increase internal validity, only.

Intervention Group 2

EXPERIMENTAL

This group is the intervention group 2 (two) that will be taught using model-based structured teaching content. In this teaching content, researchers will teach pressure injury risk factors; after teaching, participants will plan nursing interventions with Clinical Decision Support System (CDSS) integrated software. After teaching, they will be applied post tests. This group has no pre-test and will be created to increase internal validity, only.

Other: Teaching

Interventions

The intervention in this study is teaching. Researchers, will create a pressure injury teaching content and assess this effectiveness and also, intervention groups will use Clinical Decision Support System (CDSS) as a tool to plan nursing interventions.

Intervention Group 1Intervention Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The nursing student must be completed Fundamentals of Nursing course and its clinical practices.

You may not qualify if:

  • The nursing student cannot be a part of this study, if she/he graduated high school/associate degree about health department and work as a health professional.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Ozlem Ariburnu

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In this study, whole participants will be masked during the study. After study, researchers will encode the data different names and send to the statistician. Therefore, statistician will not know which group is control or intervention.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: This study was designed with Solomon four groups design. There will be control group one, control group two, intervention group one and intervention group two.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 22, 2022

Study Start

October 2, 2023

Primary Completion

January 22, 2024

Study Completion

January 22, 2024

Last Updated

February 15, 2023

Record last verified: 2023-02