Pressure InjuriesNCT07028892
Gamified Learning for Pressure Injury Prevention
A study testing A gamified mobile learning and Booklet training in people with Pressure Injuries and Pressure Ulcer Prevention, run by Mehmet Akif Ersoy University at 1 site in United States.
Trial summary
The goal of this Randomized Controlled Trial is to define the effect of gamified teaching methods for pressure injury prevention in intensive care nurses. The main questions it aims to answer are: H1: The gamified learning experience will increase the nurses' knowledge of pressure injury prevention compared to the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Injuries, Pressure Ulcer Prevention
- What is being tested?
- A gamified mobile learning and Booklet training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being Registered Nurse for more than 1 year
- Having at least an associate degree of nursing
- Having a smart-phone or tablet
- Being more than 18 years old
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Priscilla Gazarian, Ph.D. contact
United States1 site
UMass Chan Medical School
Boston, Massachusetts, 01655
Sonia Martinath, (508) 856-8999, ResearchInformaticsCore@umassmed.edu
Priscilla Gazarian, Ph.D.
About this study
Official title: Gamified Learning for Pressure Injury Prevention: A Randomized Controlled Trial to Enhance Knowledge, Skills, and Attitudes Among Nurses
The goal of this Randomized Controlled Trial is to define the effect of gamified teaching methods for pressure injury prevention in intensive care nurses. The main questions it aims to answer are:
H1: The gamified learning experience will increase the nurses' knowledge of pressure injury prevention compared to the control group.
Read more
H2: The gamified learning experience will increase the nurses' skills in pressure injury prevention compared to the control group.
H3: The gamified learning experience will increase the nurses' attitude toward pressure injury prevention compared to the control group.
Researchers will compare two arm to see if there is a difference in knowledge, skills, and attitudes. Participants in the experimental group will be educated via a gamified mobile learning application.
Read the detailed description
The inclusion criteria for the participants are: (a) being a registered nurse for more than one year, (b) being more than 18 years old, (c) having at least an associate degree in nursing, and (d) having a smartphone or tablet to be able to download the game application.
The Pressure Ulcer Knowledge Assessment Tool (PUKAT) will assess PI knowledge (Manderlier et al., 2017)
The Attitude Towards Pressure Ulcer Prevention instrument (APuP) will assess PI attitude (Beeckman et al., 2010) .
PI assessment skills will be performed in the skills laboratory at the Tan Chingfen Graduate School of Nursing with pressure injuries in various stages (stage one, stage two, stage three, stage four, unstageable stage, and deep tissue pressure injury) on the wound model. The researchers will create and validate a "Pressure Injury Evaluation Form."
- Conditions
- Pressure Injuries, Pressure Ulcer Prevention
- Being tested
- A gamified mobile learning, Booklet training
- Keywords
- intensive care nurses, gamification, mobile learning, pressure injuries
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A gamified mobile learningDevice
There will be a gamified environment in a mobile application with case scenarios on pressure injury prevention designed by researchers.
Booklet trainingOther
Nurses will receive training via a booklet about prevention of pressure injuries.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental Group will receive an education about pressure injury prevention via a gamified mobile application Receives: Device: A gamified mobile learning |
| Control Group | Active comparator | The Control Group will receive the training via a booklet. Receives: Other: Booklet training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Ulcer Knowledge Level
The Outcome will be measured by "The Pressure Ulcer Knowledge Assessment Tool (PUKAT 2.0)". PUKAT 2.0 is a 26-item questionnaire that assesses nurses' knowledge of pressure injury in six areas: etiology and development (six items), classification and observation (five items), risk assessment (two items), and nutrition (one item).
Measured: 10 weeks
Attitude Towards Pressure Ulcer Prevention
Attitude Towards Pressure Ulcer Prevention instrument (APuP) will be used for defining attitude level of ICU nurses. APuP is a reliable and valid instrument to assess attitudes towards pressure ulcer prevention. There are 13 items in this scale, each of them evaluated with a 5-point Likert.
Measured: 10 weeks
Secondary outcomes (1)
System Usability
System Usability Scale (SUS) will be used. In this study, a gamified mobile application for the prevention of pressure injuries will be developed. SUS will be used to evaluate the usability of the application.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester, Massachusetts College of Pharmacy and Health Science
- Responsible party
- Principal investigator, Sinan Aydoğan, Mehmet Akif Ersoy University
- Investigators
- Semiha Asli Bozkurt, Ph.D., Principal investigator, Massachusetts College of Pharmacy and Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028892
- Sponsor's protocol ID
- MehmetAkifU-SBF-SA-2
- Other IDs
- 40099
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aydogan S, Caliskan N. A Descriptive Study of Turkish Intensive Care Nurses' Pressure Ulcer Prevention Knowledge, Attitudes, and Perceived Barriers to Care. Wound Manag Prev. 2019 Feb;65(2):39-47.
PubMed 30730304Bozkurt, S. A., Samia, R., & Gazarian, P. K. (2023). Using standardized patient simulation in undergraduate nursing education: A scoping review. Clinical Simulation in Nursing, 74, 3-18. https://doi.org/10.1016/j.ecns.2022.10.003
Beeckman D, Defloor T, Demarre L, Van Hecke A, Vanderwee K. Pressure ulcers: development and psychometric evaluation of the attitude towards pressure ulcer prevention instrument (APuP). Int J Nurs Stud. 2010 Nov;47(11):1432-41. doi: 10.1016/j.ijnurstu.2010.04.004. Epub 2010 May 14.
PubMed 20466370Manderlier B, Van Damme N, Vanderwee K, Verhaeghe S, Van Hecke A, Beeckman D. Development and psychometric validation of PUKAT 2.0, a knowledge assessment tool for pressure ulcer prevention. Int Wound J. 2017 Dec;14(6):1041-1051. doi: 10.1111/iwj.12758. Epub 2017 May 26.
PubMed 28547752
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamified Learning for Pressure Injury Prevention: A Randomized Controlled Trial to Enhance Knowledge, Skills, and Attitudes Among Nurses
- ClinicalTrials.gov ID
- NCT07028892
- Acronym / sponsor ID
- MehmetAkifU-SBF-SA-2
- Conditions
- Pressure Injuries, Pressure Ulcer Prevention
- Keywords
- intensive care nurses, gamification, mobile learning, pressure injuries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester, Massachusetts College of Pharmacy and Health Science
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Randomized Controlled Trial is to define the effect of gamified teaching methods for pressure injury prevention in intensive care nurses. The main questions it aims to answer are:
H1: The gamified learning experience will increase the nurses' knowledge of pressure injury prevention compared to the control group.
H2: The gamified learning experience will increase the nurses' skills in pressure injury prevention compared to the control group.
H3: The gamified learning experience will increase the nurses' attitude toward pressure injury prevention compared to the control group.
Researchers will compare two arm to see if there is a difference in knowledge, skills, and attitudes. Participants in the experimental group will be educated via a gamified mobile learning application.
Detailed description
The inclusion criteria for the participants are: (a) being a registered nurse for more than one year, (b) being more than 18 years old, (c) having at least an associate degree in nursing, and (d) having a smartphone or tablet to be able to download the game application.
The Pressure Ulcer Knowledge Assessment Tool (PUKAT) will assess PI knowledge (Manderlier et al., 2017)
The Attitude Towards Pressure Ulcer Prevention instrument (APuP) will assess PI attitude (Beeckman et al., 2010) .
PI assessment skills will be performed in the skills laboratory at the Tan Chingfen Graduate School of Nursing with pressure injuries in various stages (stage one, stage two, stage three, stage four, unstageable stage, and deep tissue pressure injury) on the wound model. The researchers will create and validate a "Pressure Injury Evaluation Form."
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: A gamified mobile learningExperimental Group will receive an education about pressure injury prevention via a gamified mobile application |
| Control Group | Active comparator | Other: Booklet trainingThe Control Group will receive the training via a booklet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being Registered Nurse for more than 1 year
- Having at least an associate degree of nursing
- Having a smart-phone or tablet
- Being more than 18 years old
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A gamified mobile learningThere will be a gamified environment in a mobile application with case scenarios on pressure injury prevention designed by researchers. | Device | Experimental Group |
| Booklet trainingNurses will receive training via a booklet about prevention of pressure injuries. | Other | Control Group |
Primary outcome
Pressure Ulcer Knowledge Level
Time frame: 10 weeks
The Outcome will be measured by "The Pressure Ulcer Knowledge Assessment Tool (PUKAT 2.0)". PUKAT 2.0 is a 26-item questionnaire that assesses nurses' knowledge of pressure injury in six areas: etiology and development (six items), classification and observation (five items), risk assessment (two items), and nutrition (one item).
Attitude Towards Pressure Ulcer Prevention
Time frame: 10 weeks
Attitude Towards Pressure Ulcer Prevention instrument (APuP) will be used for defining attitude level of ICU nurses. APuP is a reliable and valid instrument to assess attitudes towards pressure ulcer prevention. There are 13 items in this scale, each of them evaluated with a 5-point Likert.
1 secondary outcome
System Usability
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Background: PubMed 30730304Aydogan S, Caliskan N. A Descriptive Study of Turkish Intensive Care Nurses' Pressure Ulcer Prevention Knowledge, Attitudes, and Perceived Barriers to Care. Wound Manag Prev. 2019 Feb;65(2):39-47.
- BackgroundBozkurt, S. A., Samia, R., & Gazarian, P. K. (2023). Using standardized patient simulation in undergraduate nursing education: A scoping review. Clinical Simulation in Nursing, 74, 3-18. https://doi.org/10.1016/j.ecns.2022.10.003
- Background: PubMed 20466370Beeckman D, Defloor T, Demarre L, Van Hecke A, Vanderwee K. Pressure ulcers: development and psychometric evaluation of the attitude towards pressure ulcer prevention instrument (APuP). Int J Nurs Stud. 2010 Nov;47(11):1432-41. doi: 10.1016/j.ijnurstu.2010.04.004. Epub 2010 May 14.
- Background: PubMed 28547752Manderlier B, Van Damme N, Vanderwee K, Verhaeghe S, Van Hecke A, Beeckman D. Development and psychometric validation of PUKAT 2.0, a knowledge assessment tool for pressure ulcer prevention. Int Wound J. 2017 Dec;14(6):1041-1051. doi: 10.1111/iwj.12758. Epub 2017 May 26.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Priscilla Gazarian, Ph.D. contact
Semiha Asli Bozkurt, Ph.D. principal investigator
Massachusetts College of Pharmacy and Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A gamified mobile learning and Booklet training in people with Pressure Injuries and Pressure Ulcer Prevention, run by Mehmet Akif Ersoy University at 1 site in United States.
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 1 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: opening soon, as of the sponsor's last update on 19 Jun 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sinan Aydogan, Ph.D. (+905457137919, saydogan@mehmetakif.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Ulcer Knowledge Level (time frame: 10 weeks). The study lists 2 primary outcomes in all. 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 NCT07028892, which also lists 4 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 19 Jun 2025.