CompetencePhase 2NPNCT02245984
Effect of Applying Paper- Based Versus Electronic Nursing Process on Clinical Competence of Nursing Student
A Phase 2 study testing paper based nursing process and electronic nursing process in people with Competence, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
Compare the clinical competence of undergraduate nursing students' of mashhad nursing and midwifery school in two groups applying nursing process (paper- based versus electronic). Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Competence
- What is being tested?
- paper based nursing process and electronic nursing process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Jul 2014to Oct 2014
- Phase
- Phase 2
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willingness to participate in the study
- No Experience working independently (student work, employment, etc.) as a Nurse.
- Participate in the first day of the internship program
Who cannot join
- Failure to complete course training
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ghaem hospital
Mashhad
mohammad rajabpoor, student, 09158341840, rajabpoorm871@gmail.com
seyed reza mazlom, phd
About this study
Official title: Comparison Effect of Applying Paper- Based Versus Electronic Nursing Process on Clinical Competence of Undergraduate Nursing Students' of Mashhad Nursing and Midwifery School
Compare the clinical competence of undergraduate nursing students' of mashhad nursing and midwifery school in two groups applying nursing process (paper- based versus electronic).
Read the detailed description
The sample consisted of at least 30 nursing students in each of the groups A (paper-based nursing process or PNP) and B (Electronic nursing process or ENP) based on random allocation (lottery sectors) will be divided into two groups. The level of knowledge about nursing process, clinical competency and clinical decision making will evaluate by the knowledge of nursing process, Meretoja competence modified and Lauri clinical decision making questionnaires, by the investigator. Then, for each of the groups separately-training program aimed to education the nursing process and how to do it (including the definition of the nursing process, advantages and its implementation and how to collect data using patient assessment forms Gordon) in the form of workshops a day (5 hours) will be implemented. Nursing process education in the two groups will similar but two hours of the program in each groups is devoted to practical training on how to implement. After completing the training program, students learn about the nursing process will be determined in the same way. Then for two weeks, students in Group A and Group B will be implemented paper and electronic nursing process for patients and researchers will perform under your guidance will be closely monitored. Clinical competence and clinical decision making will be assessed again at the end of the course with previous method. Satisfaction of the nursing process in each group will be measured.
- Conditions
- Competence
- Being tested
- paper based nursing process, electronic nursing process
- Keywords
- clinical competence, nursing process, nursing student
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paper based nursing processOther
for two weeks, students in paper based nursing group will be implemented paper nursing process for patients.
electronic nursing processOther
for each of the groups separately-training program aimed to education the nursing process and how to do it (including the definition of the nursing process, advantages and its implementation and how to collect data using patient assessment forms Gordon) in the form of workshops a day (5 hours) will be implemented. Nursing process education in the two groups will similar but two hours of the program in each groups is devoted to practical training on how to implement. After completing the training program, students learn about the nursing process will be determined in the same way. Then for two weeks, students in Group A and Group B will be implemented paper and electronic nursing process for patients.
| Study group | Role | What they receive |
|---|---|---|
| paper based nursing process | Experimental | for two weeks, students in paper based nursing group will be implemented paper nursing process for patients. Receives: Other: paper based nursing process |
| electronic nursing process | Experimental | for two weeks students in this group will be implemented electronic nursing process for patients. Receives: Other: electronic nursing process |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical competency
clinical competency will be measured with modified nursing competence scale(NCS)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
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 CompetenceStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyedreza Mazloum, Mashhad University of Medical Sciences
- Investigators
- s reza mazloum, phd, Study director, MUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245984
- Sponsor's protocol ID
- 922488
- Other IDs
- 123456
- Acronym
- NP
- Status last verified
- Sep 2014
- First submitted
- 20 Aug 2014
- Last updated
- 23 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meretoja R, Leino-Kilpi H, Kaira AM. Comparison of nurse competence in different hospital work environments. J Nurs Manag. 2004 Sep;12(5):329-36. doi: 10.1111/j.1365-2834.2004.00422.x.
PubMed 15315489
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Effect of Applying Paper- Based Versus Electronic Nursing Process on Clinical Competence of Undergraduate Nursing Students' of Mashhad Nursing and Midwifery School
- ClinicalTrials.gov ID
- NCT02245984
- Acronym / sponsor ID
- NP / 922488
- Conditions
- Competence
- Keywords
- clinical competence, nursing process, nursing student
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 22 Sep 2014 (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.
Compare the clinical competence of undergraduate nursing students' of mashhad nursing and midwifery school in two groups applying nursing process (paper- based versus electronic).
Detailed description
The sample consisted of at least 30 nursing students in each of the groups A (paper-based nursing process or PNP) and B (Electronic nursing process or ENP) based on random allocation (lottery sectors) will be divided into two groups. The level of knowledge about nursing process, clinical competency and clinical decision making will evaluate by the knowledge of nursing process, Meretoja competence modified and Lauri clinical decision making questionnaires, by the investigator. Then, for each of the groups separately-training program aimed to education the nursing process and how to do it (including the definition of the nursing process, advantages and its implementation and how to collect data using patient assessment forms Gordon) in the form of workshops a day (5 hours) will be implemented. Nursing process education in the two groups will similar but two hours of the program in each groups is devoted to practical training on how to implement. After completing the training program, students learn about the nursing process will be determined in the same way. Then for two weeks, students in Group A and Group B will be implemented paper and electronic nursing process for patients and researchers will perform under your guidance will be closely monitored. Clinical competence and clinical decision making will be assessed again at the end of the course with previous method. Satisfaction of the nursing process in each group will be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paper based nursing process | Experimental | Other: paper based nursing processfor two weeks, students in paper based nursing group will be implemented paper nursing process for patients. |
| electronic nursing process | Experimental | Other: electronic nursing processfor two weeks students in this group will be implemented electronic nursing process for patients. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Willingness to participate in the study
- No Experience working independently (student work, employment, etc.) as a Nurse.
- Participate in the first day of the internship program
Key exclusion criteria (1 listed)
- Failure to complete course training
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 |
|---|---|---|
| paper based nursing processfor two weeks, students in paper based nursing group will be implemented paper nursing process for patients. | Other | paper based nursing process |
| electronic nursing processfor each of the groups separately-training program aimed to education the nursing process and how to do it (including the definition of the nursing process, advantages and its implementation and how to collect data using patient assessment forms Gordon) in the form of workshops a day (5 hours) will be implemented. Nursing process education in the two groups will similar but two hours of the program in each groups is devoted to practical training on how to implement. After completing the training program, students learn about the nursing process will be determined in the same way. Then for two weeks, students in Group A and Group B will be implemented paper and electronic nursing process for patients. | Other | electronic nursing process |
Primary outcome
clinical competency
Time frame: 2 months
clinical competency will be measured with modified nursing competence scale(NCS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2014.
- Results publication: PubMed 15315489Meretoja R, Leino-Kilpi H, Kaira AM. Comparison of nurse competence in different hospital work environments. J Nurs Manag. 2004 Sep;12(5):329-36. doi: 10.1111/j.1365-2834.2004.00422.x.
- Mashhad University Medical of SciencesLink provided by the sponsor.
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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.
s reza mazloum, phd study director
MUMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paper based nursing process and electronic nursing process in people with Competence, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Sep 2014. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohammad rajabpoor, MS student (09158341840, rajabpoorm921@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical competency (time frame: 2 months). 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 NCT02245984, 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 23 Sep 2014.