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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Video during simulation
The intervention group simulated the bed bath while watching the video, under the supervision of the tutor
Other: Video during simulation
The intervention group simulated the bed bath while watching the video, under the supervision of the tutor
Other Names:
  • Educational
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of São Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 8, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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