StudentsNCT03318848
Use of Bed Bath Video During Simulation in Developing Student Skills
A study testing Video during simulation in people with Students, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This study´s objective was to identify the effectiveness of bed bath video during simulation in the performance of undergraduate student skills. Method. This is a randomized, blinded clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Students
- What is being tested?
- Video during simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2016to 8 Mar 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum 18 years
Who cannot join
- Students who have ever performed the bed bath
Trial locations and contacts
1 site in 1 country.
About this study
This study´s objective was to identify the effectiveness of bed bath video during simulation in the performance of undergraduate student skills. Method. This is a randomized, blinded clinical trial. The sample consisted of students of the second year of nursing graduation who were divided into two groups: intervention group (students who simulated bed bath using the video) and control group (students who simulated bed bath without the video). The primary end point was the performance of the students' abilities about bed bath procedure, which was evaluated in two moments (before and after the simulation) and we used a previously elaborated and validated checklist. Prior to the collection, the research project was submitted to the Research Ethics Committee and the data was collected after its approval.
Read the detailed description
This study´s objective was to identify the effectiveness of bed bath video during simulation in the performance of undergraduate student skills. Method. This is a randomized, blinded clinical trial. The sample consisted of students of the second year of nursing graduation who were divided into two groups: intervention group (students who simulated bed bath using the video) and control group (students who simulated bed bath without the video). The students attended an expository dialog class about bed bath, structured on the basis of literature and that subsidized the elaboration of the video and the instrument to evaluate of the performance of the abilities. After the class, the subjects were consulted about the desire to participate, and those who agreed, signed the consent form. After the theoretical class, students were invited to attend the UNIFESP Skills and Simulation Teaching Center and were randomized to one of two groups (control or intervention), according to the sequence determined by the Random System. Randomization was carried out by a teacher who did not participate of any phase of this study, with masking of this phase. After randomization, the student was instructed to perform the bed bathing procedure on the low fidelity manikin, based on the knowledge obtained in the theoretical class, and no guidance was given at this time. At this stage, the teacher evaluated the student's skills through the checklist. It is emphasized that this teacher was not informed if the student evaluated was of the control group or intervention, and there is masking of this phase. The instrument for evaluating the performance of bed bath skills was the previously prepared and validated checklist called "Instrument for bathing in the bed - IABL", which presented good internal consistency in the validation study (Cronbach's alpha = 0.896) . This instrument is composed of three topics (nursing orientation, material preparation and procedure) and 56 items, whose scores vary from 0 to 56 points, in which the higher the score the better the students' abilities performance. Each item of this instrument was observed during the execution of the procedure before and after the simulation and was considered as executed properly (1 point), inadequate (0 point) or not performed (0 point). The performance of each student was analyzed by adding the scores of the items of the instrument. Subsequent to this first evaluation, the students, both in the control group and in the intervention group, received the intervention by another teacher. The students of the control group performed the simulation of the bed bath procedure, with the aid of a tutor and the intervention group simulated the bed bath while watching the video, under the supervision of the tutor. The tutor, from both groups, acted as facilitator of the teaching-learning process, according to the needs presented during the simulation period. At the end of the simulation, the student of both groups was instructed to perform the bed bath procedure once again, and no guidance was given at this time. The performance of the student's abilities was evaluated by the same instrument and by the same teacher of the first evaluation. Prior to the collection, the research project was submitted to the Research Ethics Committee and the data was collected after its approval.
- Conditions
- Students
- Being tested
- Video during simulation
- Keywords
- students, nursing, simulation training, Instructional Films and Videos, Aptitude
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video during simulationOther
Also called Educational
The intervention group simulated the bed bath while watching the video, under the supervision of the tutor
| Study group | Role | What they receive |
|---|---|---|
| Video during simulation | Experimental | The intervention group simulated the bed bath while watching the video, under the supervision of the tutor Receives: Other: Video during simulation |
| Simulation without video | No intervention | The students of the control group performed the simulation of the bed bath procedure, with the aid of a tutor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from score of student's skills about bed bath
The student's skills was evaluated using the checklist previously elaborated and validated, immediately before and after interventions.
Measured: The students were followed for two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start1 Mar 2016
- Primary completion8 Mar 2016
- Study completion8 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StudentsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The students were randomized to one of two groups (control or intervention), according to the sequence determined by the Random System
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Juliana de Lima Lopes, Federal University of São Paulo
- Investigators
- Juliana de Lima Lopes, PhD, Principal investigator, Federal University of São PauloAlba LB Barros, PhD, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318848
- Sponsor's protocol ID
- 43095115.9.0000.5505
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We not plan to make individual participant data avaiable to other researchers.
Publications
Baxter P, Akhtar-Danesh N, Valaitis R, Stanyon W, Sproul S. Simulated experiences: nursing students share their perspectives. Nurse Educ Today. 2009 Nov;29(8):859-66. doi: 10.1016/j.nedt.2009.05.003. Epub 2009 Jun 4.
PubMed 19500886Fleming SE, Reynolds J, Wallace B. Lights... camera... action! a guide for creating a DVD/video. Nurse Educ. 2009 May-Jun;34(3):118-21. doi: 10.1097/NNE.0b013e3181a0270e.
PubMed 19412052
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Bed Bath Video During Simulation in Developing Student Skills
- ClinicalTrials.gov ID
- NCT03318848
- Acronym / sponsor ID
- 43095115.9.0000.5505
- Conditions
- Students
- Keywords
- students, nursing, simulation training, Instructional Films and Videos, Aptitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 8 Mar 2016 (actual)
- Study completion
- 8 Mar 2016 (actual)
- First posted
- 24 Oct 2017 (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.
This study´s objective was to identify the effectiveness of bed bath video during simulation in the performance of undergraduate student skills. Method. This is a randomized, blinded clinical trial. The sample consisted of students of the second year of nursing graduation who were divided into two groups: intervention group (students who simulated bed bath using the video) and control group (students who simulated bed bath without the video). The primary end point was the performance of the students' abilities about bed bath procedure, which was evaluated in two moments (before and after the simulation) and we used a previously elaborated and validated checklist. Prior to the collection, the research project was submitted to the Research Ethics Committee and the data was collected after its approval.
Detailed description
This study´s objective was to identify the effectiveness of bed bath video during simulation in the performance of undergraduate student skills. Method. This is a randomized, blinded clinical trial. The sample consisted of students of the second year of nursing graduation who were divided into two groups: intervention group (students who simulated bed bath using the video) and control group (students who simulated bed bath without the video). The students attended an expository dialog class about bed bath, structured on the basis of literature and that subsidized the elaboration of the video and the instrument to evaluate of the performance of the abilities. After the class, the subjects were consulted about the desire to participate, and those who agreed, signed the consent form. After the theoretical class, students were invited to attend the UNIFESP Skills and Simulation Teaching Center and were randomized to one of two groups (control or intervention), according to the sequence determined by the Random System. Randomization was carried out by a teacher who did not participate of any phase of this study, with masking of this phase. After randomization, the student was instructed to perform the bed bathing procedure on the low fidelity manikin, based on the knowledge obtained in the theoretical class, and no guidance was given at this time. At this stage, the teacher evaluated the student's skills through the checklist. It is emphasized that this teacher was not informed if the student evaluated was of the control group or intervention, and there is masking of this phase. The instrument for evaluating the performance of bed bath skills was the previously prepared and validated checklist called "Instrument for bathing in the bed - IABL", which presented good internal consistency in the validation study (Cronbach's alpha = 0.896) . This instrument is composed of three topics (nursing orientation, material preparation and procedure) and 56 items, whose scores vary from 0 to 56 points, in which the higher the score the better the students' abilities performance. Each item of this instrument was observed during the execution of the procedure before and after the simulation and was considered as executed properly (1 point), inadequate (0 point) or not performed (0 point). The performance of each student was analyzed by adding the scores of the items of the instrument. Subsequent to this first evaluation, the students, both in the control group and in the intervention group, received the intervention by another teacher. The students of the control group performed the simulation of the bed bath procedure, with the aid of a tutor and the intervention group simulated the bed bath while watching the video, under the supervision of the tutor. The tutor, from both groups, acted as facilitator of the teaching-learning process, according to the needs presented during the simulation period. At the end of the simulation, the student of both groups was instructed to perform the bed bath procedure once again, and no guidance was given at this time. The performance of the student's abilities was evaluated by the same instrument and by the same teacher of the first evaluation. Prior to the collection, the research project was submitted to the Research Ethics Committee and the data was collected after its approval.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The students were randomized to one of two groups (control or intervention), according to the sequence determined by the Random System
| Arm | Type | Receives |
|---|---|---|
| Video during simulation | Experimental | Other: Video during simulationThe intervention group simulated the bed bath while watching the video, under the supervision of the tutor |
| Simulation without video | No intervention | –The students of the control group performed the simulation of the bed bath procedure, with the aid of a tutor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Minimum 18 years
Key exclusion criteria (1 listed)
- Students who have ever performed the bed bath
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 |
|---|---|---|
| Video during simulationAlso: EducationalThe intervention group simulated the bed bath while watching the video, under the supervision of the tutor | Other | Video during simulation |
Primary outcome
Change from score of student's skills about bed bath
Time frame: The students were followed for two days
The student's skills was evaluated using the checklist previously elaborated and validated, immediately before and after interventions.
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 24 Oct 2017.
- Background: PubMed 19500886Baxter P, Akhtar-Danesh N, Valaitis R, Stanyon W, Sproul S. Simulated experiences: nursing students share their perspectives. Nurse Educ Today. 2009 Nov;29(8):859-66. doi: 10.1016/j.nedt.2009.05.003. Epub 2009 Jun 4.
- Background: PubMed 19412052Fleming SE, Reynolds J, Wallace B. Lights... camera... action! a guide for creating a DVD/video. Nurse Educ. 2009 May-Jun;34(3):118-21. doi: 10.1097/NNE.0b013e3181a0270e.
- Individual participant dataSharing planned: No. We not plan to make individual participant data avaiable to other researchers.
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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.
Juliana de Lima Lopes, PhD principal investigator
Federal University of São Paulo
Alba LB Barros, PhD study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video during simulation in people with Students, run by Federal University of São Paulo at 1 site in Brazil.
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 1 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 24 Oct 2017. 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 Brazil. 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 score of student's skills about bed bath (time frame: The students were followed for two days). 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 NCT03318848, which also lists 2 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 24 Oct 2017.