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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03318848
Other study ID # 43095115.9.0000.5505
Secondary ID
Status Completed
Phase N/A
First received October 2, 2017
Last updated October 20, 2017
Start date March 1, 2016
Est. completion date March 8, 2016

Study information

Verified date October 2017
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date March 8, 2016
Est. primary completion date March 8, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Minimum 18 years

Exclusion Criteria:

- Students who have ever performed the bed bath

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Video during simulation
The intervention group simulated the bed bath while watching the video, under the supervision of the tutor

Locations

Country Name City State
Brazil Federal University of São Paulo São Paulo SP

Sponsors (2)

Lead Sponsor Collaborator
Federal University of São Paulo Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. The students were followed for two days
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