- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03318848
Use of Bed Bath Video During Simulation in Developing Student Skills
October 20, 2017 updated by: Juliana de Lima Lopes, Federal University of São Paulo
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 04021001
- Federal University of São Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Minimum 18 years
Exclusion Criteria:
- Students who have ever performed the bed bath
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Video during simulation
The intervention group simulated the bed bath while watching the video, under the supervision of the tutor
|
The intervention group simulated the bed bath while watching the video, under the supervision of the tutor
Other Names:
|
NO_INTERVENTION: Simulation without video
The students of the control group performed the simulation of the bed bath procedure, with the aid of a tutor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
The students were followed for two days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Juliana de Lima Lopes, PhD, Federal University of São Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2016
Primary Completion (ACTUAL)
March 8, 2016
Study Completion (ACTUAL)
March 8, 2016
Study Registration Dates
First Submitted
October 2, 2017
First Submitted That Met QC Criteria
October 20, 2017
First Posted (ACTUAL)
October 24, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 24, 2017
Last Update Submitted That Met QC Criteria
October 20, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 43095115.9.0000.5505
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We not plan to make individual participant data avaiable to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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