Simulation of Physical IllnessNCT05685082
Teaching the Social Determinants of Health to Nursing Students With Simulation
A study testing Standardized patient simulation and Manikin-based simulation in people with Simulation of Physical Illness and Nurse's Role, run by University of Massachusetts, Boston at 1 site in United States.
Trial summary
The goal of this intervention study is to compare two different simulation modalities (standardized patient and manikin-based) in nursing student education. The main aim is to determine the effect of new scenarios on cultural awareness levels in two different types of simulation modalities and to determine the effect… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Simulation of Physical Illness, Nurse's Role
- What is being tested?
- Standardized patient simulation and Manikin-based simulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2023to 30 Jun 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being enrolled in Nursing in the Community course
- accepting to be a participant
- accepting to be recorded
Who cannot join
- not attending at least one of the prebriefing, simulation, or debriefing sessions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Boston
Boston, Massachusetts, 02125
About this study
Official title: Teaching the Social Determinants of Health to Nursing Students With Culturally Diverse Simulation: A Quasi Experimental Trial
The goal of this intervention study is to compare two different simulation modalities (standardized patient and manikin-based) in nursing student education. The main aim is to determine the effect of new scenarios on cultural awareness levels in two different types of simulation modalities and to determine the effect of new scenarios on social determinants of health knowledge levels in two different types of simulation modalities.
Participants will assign to two groups and will attend simulation sessions.
Read the detailed description
The simulation session will contain prebriefing, simulation, and debriefing. The participants will be assigned to the simulation session.
- The first group will be the standardized patient group. They will ask to fill out the Cultural Awareness Scale and social determinants of health knowledge. Then, they will attend prebriefing, standardized patient simulation, and debriefing.
- The second group will be the manikin-based group. They will ask to fill out the Cultural Awareness Scale and social determinants of health knowledge. Then, they will attend prebriefing, manikin-based simulation, and debriefing.
- Conditions
- Simulation of Physical Illness, Nurse's Role
- Being tested
- Standardized patient simulation, Manikin-based simulation
- Keywords
- Nursing student, Simulation-based training, Standardized patient simulation, Manikin-based simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized patient simulationBehavioural
The standardized patient simulation participants will receive a simulation with standardized patients on how to identify social determinants of health in an individual
Manikin-based simulationBehavioural
The manikin-based simulation participants will receive a simulation with manikins on how to identify social determinants of health in an individual
| Study group | Role | What they receive |
|---|---|---|
| Standardized patient group | Experimental | The standardized patient simulation participants will receive a simulation with standardized patients on how to identify social determinants of health in an individual Receives: Behavioral: Standardized patient simulation |
| Manikin-based group | Experimental | The manikin-based simulation participants will receive a simulation with manikins on how to identify social determinants of health in an individual Receives: Behavioral: Manikin-based simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline cultural awareness level on the 36 questions Cultural Awareness Scale
The Cultural Awareness Scale is a validated, reliable, and self-reported instrument assessing cultural awareness levels. Each statement is graded from 1=Strongly Disagree to 7=Strongly Agree. While lower scores indicate less cultural awareness, higher scores indicate greater cultural awareness (minimum = 36, maximum = 252).
Measured: Three hour
Change from baseline social determinants knowledge on the 10 questions Social Determinants of Health Survey
Social Determinants of Health Survey is a 10-question multiple-choice survey created by researchers by searching the literature. The number of responses to the answer choice is determined. The lower scores indicate fewer social determinants of health knowledge and higher scores indicate greater social determinants of health knowledge (minimum = 0, maximum = 10).
Measured: Three hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start2 Feb 2023
- Primary completion24 Feb 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation of Physical IllnessStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Boston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semiha Asli Bozkurt, University of Massachusetts, Boston
- Investigators
- Semiha Asli Bozkurt, PhD, Principal investigator, University of Massachusetts, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685082
- Sponsor's protocol ID
- BOZKURT-Int-001
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2022
- Last updated
- 26 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching the Social Determinants of Health to Nursing Students With Culturally Diverse Simulation: A Quasi Experimental Trial
- ClinicalTrials.gov ID
- NCT05685082
- Acronym / sponsor ID
- BOZKURT-Int-001
- Conditions
- Simulation of Physical Illness, Nurse's Role
- Keywords
- Nursing student, Simulation-based training, Standardized patient simulation, Manikin-based simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Massachusetts, BostonUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Jan 2023 (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 intervention study is to compare two different simulation modalities (standardized patient and manikin-based) in nursing student education. The main aim is to determine the effect of new scenarios on cultural awareness levels in two different types of simulation modalities and to determine the effect of new scenarios on social determinants of health knowledge levels in two different types of simulation modalities.
Participants will assign to two groups and will attend simulation sessions.
Detailed description
The simulation session will contain prebriefing, simulation, and debriefing. The participants will be assigned to the simulation session.
- The first group will be the standardized patient group. They will ask to fill out the Cultural Awareness Scale and social determinants of health knowledge. Then, they will attend prebriefing, standardized patient simulation, and debriefing.
- The second group will be the manikin-based group. They will ask to fill out the Cultural Awareness Scale and social determinants of health knowledge. Then, they will attend prebriefing, manikin-based simulation, and debriefing.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized patient group | Experimental | Behavioral: Standardized patient simulationThe standardized patient simulation participants will receive a simulation with standardized patients on how to identify social determinants of health in an individual |
| Manikin-based group | Experimental | Behavioral: Manikin-based simulationThe manikin-based simulation participants will receive a simulation with manikins on how to identify social determinants of health in an individual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- being enrolled in Nursing in the Community course
- accepting to be a participant
- accepting to be recorded
Key exclusion criteria (1 listed)
- not attending at least one of the prebriefing, simulation, or debriefing sessions
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 |
|---|---|---|
| Standardized patient simulationThe standardized patient simulation participants will receive a simulation with standardized patients on how to identify social determinants of health in an individual | Behavioural | Standardized patient group |
| Manikin-based simulationThe manikin-based simulation participants will receive a simulation with manikins on how to identify social determinants of health in an individual | Behavioural | Manikin-based group |
Primary outcome
Change from baseline cultural awareness level on the 36 questions Cultural Awareness Scale
Time frame: Three hour
The Cultural Awareness Scale is a validated, reliable, and self-reported instrument assessing cultural awareness levels. Each statement is graded from 1=Strongly Disagree to 7=Strongly Agree. While lower scores indicate less cultural awareness, higher scores indicate greater cultural awareness (minimum = 36, maximum = 252).
Change from baseline social determinants knowledge on the 10 questions Social Determinants of Health Survey
Time frame: Three hour
Social Determinants of Health Survey is a 10-question multiple-choice survey created by researchers by searching the literature. The number of responses to the answer choice is determined. The lower scores indicate fewer social determinants of health knowledge and higher scores indicate greater social determinants of health knowledge (minimum = 0, maximum = 10).
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 26 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Semiha Asli Bozkurt, PhD principal investigator
University of Massachusetts, Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized patient simulation and Manikin-based simulation in people with Simulation of Physical Illness and Nurse's Role, run by University of Massachusetts, Boston 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 3 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: finished, as of the sponsor's last update on 26 Jan 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 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?
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?
Change from baseline cultural awareness level on the 36 questions Cultural Awareness Scale (time frame: Three hour). 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?
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 26 Jan 2024.