Pressure UlcersNCT06634095
Effect of Moulage on Self-efficacy and Clinical Practice in Pressure Sores
A study testing Moulage group in people with Pressure Ulcers, run by Cukurova University at 2 sites in Turkey (Türkiye).
Trial summary
In the process of preventing, treating and caring for pressure ulcers, nurses take on an important responsibility and are one of the most common adverse events during hospitalizations worldwide. Pressure ulcers, which are a serious problem especially in cases requiring long-term care. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- Moulage group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 3 Jan 2025
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Students who have clinical field experience (internship),
- Volunteer to participate in the study,
- Have no attendance problems will be included in the study.
Who cannot join
- Students without clinical internship experience,
- Those who do not voluntarily participate in the work,
- Those with attendance issues will not be included in the work.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Van Yuzuncu Yıl University
Van, Tuşba, 65080
VAN YYU Faculty of Health Sciences
Van, 65080
About this study
Official title: The Effect of Using Moulage-Assisted Standardized Patient Simulation on Nursing Students
In the process of preventing, treating and caring for pressure ulcers, nurses take on an important responsibility and are one of the most common adverse events during hospitalizations worldwide. Pressure ulcers, which are a serious problem especially in cases requiring long-term care. These ulcers occur as a result of prolonged exposure of soft tissues to pressure and can lead to local tissue damage, carrying the risk of infection. In Turkey, pressure ulcers are considered an indicator of patient care quality for healthcare institutions, and many healthcare institutions continue their efforts to reduce the rate of pressure ulcers.
Read the detailed description
Moulage-supported education provides appropriate care that increases the quality of care. Therefore, it is critical for nurses to develop pressure injury assessment skills before and after graduation. However, in clinical settings, there are challenges such as limited opportunities for developing psychomotor skills, increasing student numbers, complexity of the healthcare system, and patient safety issues. In response to these challenges, the importance of simulation-based education that provides practices similar to clinical experience has emerged. Moulage plays an important role in high-quality simulations that appeal to many senses. Moulage can be defined as the application of make-up or other elements to add realism to simulation training by creating realistic-looking wounds. The use of moulage provides a valuable opportunity for practical experience that can be perceived by many senses such as vision, hearing and touch. The use of moulage helps students understand the etiology, physiology and healing processes of the wound and is an effective tool for developing wound assessment skills.
Simulated patients, known as standardized patients, which have recently emerged, are used to promote performance, competence and knowledge development among nursing students. Standardized patients help students improve their clinical and speaking performances by providing them with the opportunity to realistically play the role of a patient with a health problem.
Evaluating nursing students' perceptions and thoughts about clinical practice and their self-efficacy perceptions can contribute to the development of more effective strategies by evaluating the effectiveness of clinical practice strategies.
No research has been found on the effect of the use of moulage-supported standardized patient simulation on nursing students' self-efficacy and clinical practice attitudes towards pressure ulcers. This study is planned to be conducted as an experimental study to investigate the effect of the use of moulage-supported standardized patient simulation on nursing students' self-efficacy and clinical practice attitudes towards pressure ulcers.
- Conditions
- Pressure Ulcers
- Being tested
- Moulage group
- Keywords
- self-sufficiency, Moulage, Clinical Practice Regarding
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moulage groupBehavioural
Also called Control Group
The experimental group is trained with a moulage-supported standardized patient simulation. Participants in the experimental group practice during the specified moulage-supported standardized patient simulation. Moulage-supported simulations regarding pressure ulcers will be created and training will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Moulage group | Experimental | "It will consist of students trained with standardized patient simulation supported by a model." Receives: Behavioral: Moulage group |
| Contol group | No intervention | Students in the control group will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Injury Management Self-Efficacy Scale for Nurses
Each item in the 10-item survey is scored from 1 (not competent at all) to 5 (completely competent). It should be measured using 0-100 points. The total score range to be obtained from the scale is 0-100.
Measured: Baseline and 12 week
Secondary outcomes (1)
Attitude Scale for Nursing Students Towards Clinical Practices
The scale items are of 5-point Likert type, scored as "Strongly disagree (1 point)", "Disagree (2 points)", "Undecided (3 points)", "Agree (4 points)" and Strongly Agree (5 points)". The lowest score that can be obtained from the scale is 26, the highest score is 130, and an increase in the total score indicates that students have developed a positive attitude towards clinical practice.
Measured: Baseline and 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Oct 2024
- Primary completion3 Jan 2025
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental, randomised controlled, single-blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahri AŞKAN, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634095
- Sponsor's protocol ID
- 2024 03-04
- Status last verified
- May 2025
- First submitted
- 14 Sep 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Celik H, Ozer M, Zincir H. Modification and Validation of the Vaccine Hesitancy Scale for Turkish Adult Vaccination. J Nurs Meas. 2024 Mar 14;32(1):82-94. doi: 10.1891/JNM-2022-0020.
PubMed 37827583Gilkey MB, McRee AL, Magnus BE, Reiter PL, Dempsey AF, Brewer NT. Vaccination Confidence and Parental Refusal/Delay of Early Childhood Vaccines. PLoS One. 2016 Jul 8;11(7):e0159087. doi: 10.1371/journal.pone.0159087. eCollection 2016.
PubMed 27391098Franklin MD, Schlundt DG, Wallston KA. Development and validation of a religious health fatalism measure for the African-American faith community. J Health Psychol. 2008 Apr;13(3):323-35. doi: 10.1177/1359105307088137.
PubMed 18420767Costa JC, Weber AM, Darmstadt GL, Abdalla S, Victora CG. Religious affiliation and immunization coverage in 15 countries in Sub-Saharan Africa. Vaccine. 2020 Jan 29;38(5):1160-1169. doi: 10.1016/j.vaccine.2019.11.024. Epub 2019 Nov 30.
PubMed 31791811Ahmed A, Lee KS, Bukhsh A, Al-Worafi YM, Sarker MMR, Ming LC, Khan TM. Outbreak of vaccine-preventable diseases in Muslim majority countries. J Infect Public Health. 2018 Mar-Apr;11(2):153-155. doi: 10.1016/j.jiph.2017.09.007. Epub 2017 Oct 4.
PubMed 28988775Sarpdagi Y, Kaplan E, Sir O, Askan F, Yildiz M. The effect of moulage supported standardised patient simulation on nursing students' self-efficacy and clinical practice attitudes towards pressure injuries : A randomised controlled study. Nurse Educ Pract. 2026 Jan;90:104695. doi: 10.1016/j.nepr.2025.104695. Epub 2025 Dec 17.
PubMed 41420980
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Moulage-Assisted Standardized Patient Simulation on Nursing Students
- ClinicalTrials.gov ID
- NCT06634095
- Acronym / sponsor ID
- 2024 03-04
- Conditions
- Pressure Ulcers
- Keywords
- self-sufficiency, Moulage, Clinical Practice Regarding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 9 Oct 2024 (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.
In the process of preventing, treating and caring for pressure ulcers, nurses take on an important responsibility and are one of the most common adverse events during hospitalizations worldwide. Pressure ulcers, which are a serious problem especially in cases requiring long-term care. These ulcers occur as a result of prolonged exposure of soft tissues to pressure and can lead to local tissue damage, carrying the risk of infection. In Turkey, pressure ulcers are considered an indicator of patient care quality for healthcare institutions, and many healthcare institutions continue their efforts to reduce the rate of pressure ulcers.
Detailed description
Moulage-supported education provides appropriate care that increases the quality of care. Therefore, it is critical for nurses to develop pressure injury assessment skills before and after graduation. However, in clinical settings, there are challenges such as limited opportunities for developing psychomotor skills, increasing student numbers, complexity of the healthcare system, and patient safety issues. In response to these challenges, the importance of simulation-based education that provides practices similar to clinical experience has emerged. Moulage plays an important role in high-quality simulations that appeal to many senses. Moulage can be defined as the application of make-up or other elements to add realism to simulation training by creating realistic-looking wounds. The use of moulage provides a valuable opportunity for practical experience that can be perceived by many senses such as vision, hearing and touch. The use of moulage helps students understand the etiology, physiology and healing processes of the wound and is an effective tool for developing wound assessment skills.
Simulated patients, known as standardized patients, which have recently emerged, are used to promote performance, competence and knowledge development among nursing students. Standardized patients help students improve their clinical and speaking performances by providing them with the opportunity to realistically play the role of a patient with a health problem.
Evaluating nursing students' perceptions and thoughts about clinical practice and their self-efficacy perceptions can contribute to the development of more effective strategies by evaluating the effectiveness of clinical practice strategies.
No research has been found on the effect of the use of moulage-supported standardized patient simulation on nursing students' self-efficacy and clinical practice attitudes towards pressure ulcers. This study is planned to be conducted as an experimental study to investigate the effect of the use of moulage-supported standardized patient simulation on nursing students' self-efficacy and clinical practice attitudes towards pressure ulcers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental, randomised controlled, single-blind study
| Arm | Type | Receives |
|---|---|---|
| Moulage group | Experimental | Behavioral: Moulage group"It will consist of students trained with standardized patient simulation supported by a model." |
| Contol group | No intervention | –Students in the control group will receive standard care. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Students who have clinical field experience (internship),
- Volunteer to participate in the study,
- Have no attendance problems will be included in the study.
Key exclusion criteria (3 listed)
- Students without clinical internship experience,
- Those who do not voluntarily participate in the work,
- Those with attendance issues will not be included in the work.
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 |
|---|---|---|
| Moulage groupAlso: Control GroupThe experimental group is trained with a moulage-supported standardized patient simulation. Participants in the experimental group practice during the specified moulage-supported standardized patient simulation. Moulage-supported simulations regarding pressure ulcers will be created and training will be provided. | Behavioural | Moulage group |
Primary outcome
Pressure Injury Management Self-Efficacy Scale for Nurses
Time frame: Baseline and 12 week
Each item in the 10-item survey is scored from 1 (not competent at all) to 5 (completely competent). It should be measured using 0-100 points. The total score range to be obtained from the scale is 0-100.
1 secondary outcome
Attitude Scale for Nursing Students Towards Clinical Practices
Time frame: Baseline and 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Background: PubMed 37827583Celik H, Ozer M, Zincir H. Modification and Validation of the Vaccine Hesitancy Scale for Turkish Adult Vaccination. J Nurs Meas. 2024 Mar 14;32(1):82-94. doi: 10.1891/JNM-2022-0020.
- Results publication: PubMed 27391098Gilkey MB, McRee AL, Magnus BE, Reiter PL, Dempsey AF, Brewer NT. Vaccination Confidence and Parental Refusal/Delay of Early Childhood Vaccines. PLoS One. 2016 Jul 8;11(7):e0159087. doi: 10.1371/journal.pone.0159087. eCollection 2016.
- Results publication: PubMed 18420767Franklin MD, Schlundt DG, Wallston KA. Development and validation of a religious health fatalism measure for the African-American faith community. J Health Psychol. 2008 Apr;13(3):323-35. doi: 10.1177/1359105307088137.
- Results publication: PubMed 31791811Costa JC, Weber AM, Darmstadt GL, Abdalla S, Victora CG. Religious affiliation and immunization coverage in 15 countries in Sub-Saharan Africa. Vaccine. 2020 Jan 29;38(5):1160-1169. doi: 10.1016/j.vaccine.2019.11.024. Epub 2019 Nov 30.
- Results publication: PubMed 28988775Ahmed A, Lee KS, Bukhsh A, Al-Worafi YM, Sarker MMR, Ming LC, Khan TM. Outbreak of vaccine-preventable diseases in Muslim majority countries. J Infect Public Health. 2018 Mar-Apr;11(2):153-155. doi: 10.1016/j.jiph.2017.09.007. Epub 2017 Oct 4.
- Derived from this study: PubMed 41420980Sarpdagi Y, Kaplan E, Sir O, Askan F, Yildiz M. The effect of moulage supported standardised patient simulation on nursing students' self-efficacy and clinical practice attitudes towards pressure injuries : A randomised controlled study. Nurse Educ Pract. 2026 Jan;90:104695. doi: 10.1016/j.nepr.2025.104695. Epub 2025 Dec 17.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moulage group in people with Pressure Ulcers, run by Cukurova University at 2 sites 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 3 inclusion and 3 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 3 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 2 sites 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?
Pressure Injury Management Self-Efficacy Scale for Nurses (time frame: Baseline and 12 week). 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 NCT06634095, which also lists 6 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 3 Jun 2025.