Nursing StudentsNCT01614314
Dressing of Tunneled Central Venous Catheter
A study testing Preceptorship and Auto-instructional guide in people with Nursing Students, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study was to compare the performance of nursing undergraduates in dressing of tunneled central venous access in the simulator, according to the aid of a preceptorship or an auto-instructional guide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nursing Students
- What is being tested?
- Preceptorship and Auto-instructional guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Dec 2011
- 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
- students regularly enrolled in the last year of the undergraduate nursing program of a public university
Who cannot join
- students who did not comply with any of the study's phases
- students who presented performance > 70% in the pretest
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo at College of Nursing
Ribeirão Preto, São Paulo, 14040902
About this study
Official title: Dressing of Tunneled Central Venous Catheter: Preceptorship's Presence or Use of Auto-instructional Guide
The purpose of this study was to compare the performance of nursing undergraduates in dressing of tunneled central venous access in the simulator, according to the aid of a preceptorship or an auto-instructional guide.
Read the detailed description
The simulation facilitates the acquisition of knowledge, skills and decision-making required for clinical practice. Mentoring has been employed and valued as pedagogical process qualifier.
The hypothesis of this study was that students who trained with the assistance of a preceptorship had better practical performance when compared to students who used an auto-instructional guide.
- Conditions
- Nursing Students
- Being tested
- Preceptorship, Auto-instructional guide
- Keywords
- Preceptorship, simulation, nursing, catheters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreceptorshipOther
After attending a lecture and a video on the dressing of the tunneled central venous catheter, the subjects performed the procedure on a manikin simulator, with the aid of a nurse preceptorship, lasting one hour.
Auto-instructional guideOther
After attending a lecture and a video on the dressing of the tunneled central venous catheter, the subjects performed the procedure on a manikin simulator, with the aid of an auto-instructional guide, lasting one hour.
| Study group | Role | What they receive |
|---|---|---|
| Auto-instructional guide | Active comparator | The subjects performed the procedure on a manikin simulator, with the aid of an auto-instructional guide, lasting one hour. Receives: Other: Auto-instructional guide |
| Preceptorship | Experimental | The subjects performed the procedure on a manikin simulator, with the aid of a nurse preceptorship, lasting one hour. Receives: Other: Preceptorship |
What is being measured
The primary outcome is the main question the study is designed to answer.
Practical performance in carrying out dressing procedure
The practical performance in carrying out dressing procedure of each student was analyzed according to a list of 28 steps of procedure, including the preparation of environment and material, antisepsis, curative application and recording (score: 0 to 35). The list of items used to analyze the steps of the catheter dressing procedure were face and content validated by five experts working in the oncology field.
Measured: 1 day, immediately after the training simulator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nursing StudentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Titareli Merizio Martins Braga, University of Sao Paulo
- Investigators
- Fernanda TM Braga, PhD, RN, Principal investigator, University of Sao Paulo at College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614314
- Sponsor's protocol ID
- CVCdressing
- Status last verified
- Jun 2012
- First submitted
- 5 Jun 2012
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Marmol MT, Braga FT, Garbin LM, Moreli L, dos Santos CB, de Carvalho EC. Central catheter dressing in a simulator: the effects of tutor's assistance or self-learning tutorial. Rev Lat Am Enfermagem. 2012 Nov-Dec;20(6):1134-41. doi: 10.1590/s0104-11692012000600016. English, Portuguese, Spanish.
PubMed 23258727
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dressing of Tunneled Central Venous Catheter: Preceptorship's Presence or Use of Auto-instructional Guide
- ClinicalTrials.gov ID
- NCT01614314
- Acronym / sponsor ID
- CVCdressing
- Conditions
- Nursing Students
- Keywords
- Preceptorship, simulation, nursing, catheters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to compare the performance of nursing undergraduates in dressing of tunneled central venous access in the simulator, according to the aid of a preceptorship or an auto-instructional guide.
Detailed description
The simulation facilitates the acquisition of knowledge, skills and decision-making required for clinical practice. Mentoring has been employed and valued as pedagogical process qualifier.
The hypothesis of this study was that students who trained with the assistance of a preceptorship had better practical performance when compared to students who used an auto-instructional guide.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auto-instructional guide | Active comparator | Other: Auto-instructional guideThe subjects performed the procedure on a manikin simulator, with the aid of an auto-instructional guide, lasting one hour. |
| Preceptorship | Experimental | Other: PreceptorshipThe subjects performed the procedure on a manikin simulator, with the aid of a nurse preceptorship, lasting one hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- students regularly enrolled in the last year of the undergraduate nursing program of a public university
Key exclusion criteria (2 listed)
- students who did not comply with any of the study's phases
- students who presented performance > 70% in the pretest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PreceptorshipAfter attending a lecture and a video on the dressing of the tunneled central venous catheter, the subjects performed the procedure on a manikin simulator, with the aid of a nurse preceptorship, lasting one hour. | Other | Preceptorship |
| Auto-instructional guideAfter attending a lecture and a video on the dressing of the tunneled central venous catheter, the subjects performed the procedure on a manikin simulator, with the aid of an auto-instructional guide, lasting one hour. | Other | Auto-instructional guide |
Primary outcome
Practical performance in carrying out dressing procedure
Time frame: 1 day, immediately after the training simulator
The practical performance in carrying out dressing procedure of each student was analyzed according to a list of 28 steps of procedure, including the preparation of environment and material, antisepsis, curative application and recording (score: 0 to 35). The list of items used to analyze the steps of the catheter dressing procedure were face and content validated by five experts working in the oncology field.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
- Derived from this study: PubMed 23258727Marmol MT, Braga FT, Garbin LM, Moreli L, dos Santos CB, de Carvalho EC. Central catheter dressing in a simulator: the effects of tutor's assistance or self-learning tutorial. Rev Lat Am Enfermagem. 2012 Nov-Dec;20(6):1134-41. doi: 10.1590/s0104-11692012000600016. English, Portuguese, Spanish.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernanda TM Braga, PhD, RN principal investigator
University of Sao Paulo at College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preceptorship and Auto-instructional guide in people with Nursing Students, run by University of Sao 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 2 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 11 Jun 2012. 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?
Practical performance in carrying out dressing procedure (time frame: 1 day, immediately after the training simulator). 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 NCT01614314, which also lists 1 linked publication.
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 11 Jun 2012.