NCT03318848

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

7 days

First QC Date

October 2, 2017

Last Update Submit

October 20, 2017

Conditions

Keywords

students, nursingsimulation trainingInstructional Films and VideosAptitude

Outcome Measures

Primary Outcomes (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.

    The students were followed for two days

Study Arms (2)

Video during simulation

EXPERIMENTAL

The intervention group simulated the bed bath while watching the video, under the supervision of the tutor

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.

Interventions

The intervention group simulated the bed bath while watching the video, under the supervision of the tutor

Also known as: Educational
Video during simulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimum 18 years

You may not qualify if:

  • Students who have ever performed the bed bath

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04021001, Brazil

Location

Related 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.

    PMID: 19500886BACKGROUND
  • 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.

    PMID: 19412052BACKGROUND

Study Officials

  • Juliana de Lima Lopes, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR
  • Alba LB Barros, PhD

    Federal University of São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The teacher that evaluated the students, was not informed if the student was of the control or intervention group. The outcomes assessor was not informed if the group 1 and 2 was control or intervention group.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The students were randomized to one of two groups (control or intervention), according to the sequence determined by the Random System
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 24, 2017

Study Start

March 1, 2016

Primary Completion

March 8, 2016

Study Completion

March 8, 2016

Last Updated

October 24, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

We not plan to make individual participant data avaiable to other researchers.

Locations