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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Brazil1 site
  • Federal University of São Paulo

    São Paulo, São Paulo, 04021001

Other trials in Brazil

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 groups in NCT03318848
Study groupRoleWhat they receive
Video during simulationExperimentalThe intervention group simulated the bed bath while watching the video, under the supervision of the tutor
Receives: Other: Video during simulation
Simulation without videoNo interventionThe 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.

  1. 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.

  1. First posted24 Oct 2017
  2. Study start1 Mar 2016
  3. Primary completion8 Mar 2016
  4. Study completion8 Mar 2016

Resources

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)
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 19500886
  • Fleming 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

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.

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