Patient OutcomesNCT06484270
Effect of Simulation Based Safety Mobilization Program on Patient Outcomes
A study testing Simulation based safety mobilization program in people with Patient Outcomes and Simulation Based Learning, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to evaluate the effect of safe mobilization training given to nurses through simulation-based learning method on patient care results.. The main questions it aims to answer are: Is the safe mobilization training given to nurses by simulation-based learning method effective on the performance… Read more about this study
- Who is it for?
- Ages 22 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Outcomes, Simulation Based Learning
- What is being tested?
- Simulation based safety mobilization program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Jun 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 22 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Nurses Inclusion Criteria:
- Agreeing to participate in the study,
- Having no simulation-based learning experience before the study,
- Being a bachelor's degree,
- Being actively working in the data collection process.
- Working in the Surgery Clinic for at least 3 months.
Patient Inclusion Criteria:
- Agreeing to participate in the study,
- Not having a mental or cognitive disease
- Having undergone major surgery
Nurses Exclusion Criteria:
- Be a simulation-based learning experience
- Have less than 3 months of professional experience
Patient Exclusion Criteria:
- Having undergone minor surgery
- Having a mental or cognitive disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Simulation Based Safety Mobilization Program Toward Nurses on Patient Outcomes
The aim of the study was to evaluate the effect of safe mobilization training given to nurses through simulation-based learning method on patient care results.. The main questions it aims to answer are:
Is the safe mobilization training given to nurses by simulation-based learning method effective on the performance of nurses? Is the safe mobilization training given to nurses through simulation-based learning effective on patient outcomes?
Read more
Researchers will compare drug ABC to a placebo (a look-alike substance that contains no drug) to see if drug ABC works to treat severe asthma.
Nurse Participants will:
Experimental group: Take simulation based safety mobilization program for 4 weeks Control group: Theoretical education for 1 week (two hours)
Patient Participans will:
He/she mobilized by experimental/control groups nurse and care outcomes are measured for 1 week (once before and after practice)
- Conditions
- Patient Outcomes, Simulation Based Learning
- Being tested
- Simulation based safety mobilization program
- Keywords
- simulation based learning, patient outcomes, safety mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation based safety mobilization programOther
Nurse participants experienced safe patient mobilization with a simulation-based learning method with a standardized patient for 4 weeks.
Patient participants were mobilized safely under the supervision of a nurse and the care results were measured.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Nurses receiving simulation-based training Patients receiving care from these nurses Receives: Other: Simulation based safety mobilization program |
| Control group | No intervention | Nurses receiving theoritical education Patients receiving care from these nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Practice performance
The performance of nurses in the intervention and control groups during the mobilization experiences was measured with a checklist.
Measured: one week during the simulation experience
Patient outcomes- Blood pressure
It is measured to determine the effect of mobilization performed by nurses in the intervention and control groups on vital sign-blood pressure.
Measured: Before and after the patient's first mobilization during a day
Patient outcomes-Amount of Wound Drenage (ml)
It is measured to determine the effect of mobilization performed by nurses in the intervention and control groups on surgical field drenage.
Measured: Before and after the patient's first mobilization during a day
Patient outcomes-Satisfaction questionnaire
It is measured to determine the effect of mobilization performed by nurses in the intervention and control groups on satisfaction. This questionaire was evaluated by the patient between 1 and 10 points. 1 being the lowest and 10 being the highest.
Measured: Before and after the patient's first mobilization during a day
Patient outcomes-Pain scale
It is measured to determine the effect of mobilization performed by nurses in the intervention and control groups on pain. This measurement was made with a visual analog scale.This scale was evaluated by the patient between 1 and 10 points. 1 being the lowest and 10 being the highest.
Measured: Before and after the patient's first mobilization during a day
Patient outcomes- Heart rate
It is measured to determine the effect of mobilization performed by nurses in the intervention and control groups on vital signs-heart rate.
Measured: Before and after the patient's first mobilization during a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jan 2024
- Primary completion1 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient OutcomesStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- An experimental and follow-up study a pre-test, post-test with control group.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pınar dogan, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484270
- Sponsor's protocol ID
- 13579
- Status last verified
- Aug 2024
- First submitted
- 12 Jun 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation Based Safety Mobilization Program Toward Nurses on Patient Outcomes
- ClinicalTrials.gov ID
- NCT06484270
- Acronym / sponsor ID
- 13579
- Conditions
- Patient Outcomes, Simulation Based Learning
- Keywords
- simulation based learning, patient outcomes, safety mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 Jul 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.
The aim of the study was to evaluate the effect of safe mobilization training given to nurses through simulation-based learning method on patient care results.. The main questions it aims to answer are:
Is the safe mobilization training given to nurses by simulation-based learning method effective on the performance of nurses? Is the safe mobilization training given to nurses through simulation-based learning effective on patient outcomes?
Researchers will compare drug ABC to a placebo (a look-alike substance that contains no drug) to see if drug ABC works to treat severe asthma.
Nurse Participants will:
Experimental group: Take simulation based safety mobilization program for 4 weeks Control group: Theoretical education for 1 week (two hours)
Patient Participans will:
He/she mobilized by experimental/control groups nurse and care outcomes are measured for 1 week (once before and after practice)
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- An experimental and follow-up study a pre-test, post-test with control group.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Simulation based safety mobilization programNurses receiving simulation-based training Patients receiving care from these nurses |
| Control group | No intervention | –Nurses receiving theoritical education Patients receiving care from these nurses |
Who may qualify
- Ages
- 22 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Simulation based safety mobilization programNurse participants experienced safe patient mobilization with a simulation-based learning method with a standardized patient for 4 weeks. Patient participants were mobilized safely under the supervision of a nurse and the care results were measured. | Other | Experimental group |
Primary outcome
Practice performance
Time frame: one week during the simulation experience
The performance of nurses in the intervention and control groups during the mobilization experiences was measured with a checklist.
Patient outcomes- Blood pressure
Time frame: Before and after the patient's first mobilization during a day
It is measured to determine the effect of mobilization performed by nurses in the intervention and control groups on vital sign-blood pressure.
Patient outcomes-Amount of Wound Drenage (ml)
Time frame: Before and after the patient's first mobilization during a day
It is measured to determine the effect of mobilization performed by nurses in the intervention and control groups on surgical field drenage.
Patient outcomes-Satisfaction questionnaire
Time frame: Before and after the patient's first mobilization during a day
It is measured to determine the effect of mobilization performed by nurses in the intervention and control groups on satisfaction. This questionaire was evaluated by the patient between 1 and 10 points. 1 being the lowest and 10 being the highest.
Patient outcomes-Pain scale
Time frame: Before and after the patient's first mobilization during a day
It is measured to determine the effect of mobilization performed by nurses in the intervention and control groups on pain. This measurement was made with a visual analog scale.This scale was evaluated by the patient between 1 and 10 points. 1 being the lowest and 10 being the highest.
Patient outcomes- Heart rate
Time frame: Before and after the patient's first mobilization during a day
It is measured to determine the effect of mobilization performed by nurses in the intervention and control groups on vital signs-heart rate.
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 12 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation based safety mobilization program in people with Patient Outcomes and Simulation Based Learning, run by Istanbul Medipol University Hospital 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?
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 12 Aug 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?
Practice performance (time frame: one week during the simulation experience). The study lists 6 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 12 Aug 2024.