Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03592875 |
| Other study ID # |
48259915.1.0000.5009 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2018 |
| Est. completion date |
December 30, 2018 |
Study information
| Verified date |
July 2018 |
| Source |
Faculdade de Medicina do ABC |
| Contact |
Rosicley S Silva, Bachelor's |
| Phone |
+55 68 99052099 |
| Email |
rosicley_[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Objective to analyse the performance of nurses in the implementation of Nursing Care
Systematization - (NCS). This Study is a descriptive research developed from a qualitative
approach. The content analysis must be developed through three chronological poles allowing
the researcher to construct an analysis structure that corresponds to the needs of the
research and the objectives of the proposed research; The chronological poles of content
analysis are described as: Phase 1 - Pre-analysis, Phase 2 - Exploration of the material:
Phase 3 - Treatment of the results obtained and interpretation. Only a semi-structured
interview will be conducted with the research subjects who meet the inclusion criteria of the
study, preserving the identity of the individuals and guaranteeing the right to quit the
research at any time during the interview.
Description:
Study design
It is a descriptive research developed from a qualitative approach. The descriptive study
will allow to accurately present facts or phenomena of the studied reality.
The qualitative approach, according to Minayo (2010), arises from the impossibility of
investigating and understanding by mean of statistical data some phenomena focused on
perception, intuition and subjectivity. Through qualitative evaluation will be exposed
experience and common sense through the actions of understanding, interpreting and promoting
the dialectics necessary for understanding.
Research scenario
The implementation of this research protocol will be performed at Hospital of Rio Branco -
HUERB, an institution maintained by the state public administration, linked to the State
Health Secretariat, a member of the Unified Health System (SUS). The mission of HUERB is to
provide humanized care with quality and ethics, respecting socio-cultural diversity to all
who seek an emergency care service.
This emergency service attends clinical emergencies, surgical and traumatic in adults and
children, with back up beds in medical clinic, treatment of acute intoxication and alcohol
and other drug withdrawal, paediatric emergency, surgical centre and service of intensive
care unit. Altogether there are two hundred and four beds distributed between beds of
hospitalization, observation and emergency.
This component of the Urgency and Emergency Network is one of the entry points for secondary
level of health care and is a reference for the entire State of Acre, Brazil, and border
countries, Bolivia and Peru.
Study participants
Will be part of the set of research participants the professional nurses who perform
assistance activities in Hospital of Rio Branco- HUERB at the Emergency Hospital of Rio
Branco. It is estimated 30 interviews that will be consolidated by the saturation method.
Collection instrument of empirical material
A semi-structured interview will be used for data collection with 16 guiding questions
addressing aspects related to NCS knowledge and practices.
The semi-structured interviews will valorise the researcher's presence and offer all possible
perspectives to reach the spontaneity necessary for qualitative research. The interviews
start from certain questions that are not born a priori, but from information that the
researcher already has about the phenomenon that is of interest to study. In this sense, the
informant will have the freedom to follow the line of his thought and his experiences within
the main focus placed by the investigator.
Process of Saturation, Corpus Organization and Data Analysis
The organization of the chronological poles will be carried out according to the technique of
Content Analysis (CA) through stages that will enable to describe and interpret the subjects'
speeches (Bardin, 2009).
According to Bardin (2009) the content analysis must be developed through three chronological
poles allowing the researcher to construct an analysis structure that corresponds to the
needs of the research and the objectives of the proposed research;
- Phase 1 - Pre-analysis: stage of the organization itself. In it the documents that will
be submitted for analysis are selected, the hypotheses and the objectives are formulated
and the rules that base the final interpretation are elaborated.
- Phase 2 - Material exploration: this stage consists essentially of coding, discount or
enumeration operations, according to pre-formulated rules. It constitutes the
identification of the units of record, units of context and subjects that arise from the
readings. In this stage, the thematic units and registration units of this study will be
identified. It is emphasized that the thematic categories that were explored in this
phase will be built focused on the objectives in the previous phase.
- Phase 3 - Treatment of results obtained and interpretation: the gross results will be
treated in a way that in the end has a meaning. At this stage, the investigator may
propose inferences and advance interpretations about the intended objectives or relate
to other unexpected discoveries.
For the completion of data collection (conducting interviews) the researcher will consider
the process of saturation of the speeches of the subjects which consists in analysing the
empirical data that will be collected. The investigator should focus on the perception of the
decrease of new information in each interview, considering the saturation point when the new
interviews do not present additions or insignificant information to the research directed by
the objectives of the protocol.
Following the steps proposed by Bardin in the pre-analysis the researcher will transcribe the
interviews that will allow the floating reading necessary for the initial organization of
CORPUS (set of documents that will be exposed to the analysis) that will be analysed;
Reaffirmed the objectives of the study, that are: understand the nurses' perception about
NCS; Describe the panorama of nursing professional performance in a hospital environment
without NCS; Identify in nurses' practices elements that are consistent with the NCS; and
identify elements that hinder the NCS implementation process.
Based on the objectives of the study, the researcher predetermined the thematic categories
named as:
1. Daily practices in assistance;
2. The NCS Knowledge;
3. Difficulties to implement the NCS;
4. The NCS training and
5. The NCS importance. Thus, to determine the end of the collection, the saturation process
will be used; the researcher should consider the convergence of the respondents'
speeches considering the categories mentioned above.
For the development of the content analysis is oriented the codification of textual fragments
called record units (RU) and subsequent construction of the called context units (CU) that
provide sensing to the speeches of respondents; for the implementation of the codification,
in the material exploration stage, rules were defined for the systematic development of the
enumeration and codification of the registration units by the researcher. The default rules
were:
Define representative colours for each category: Category 1 = YELLOW; Category 2 = RED;
Category 3 = GREEN; Category 4 = BLUE; and category 5 = PINK;
1. Cut the UR by marking the colour of the representative category;
2. Use the weighted frequency method to determine the representativeness of the categories
in the subjects' speeches;
3. To evaluate the URs of NCS KNOWLEDGE using the intensity and direction method through
the bipolar scale;
4. Construct the CU using as reference the RUs and inferences arising from the exploration
of the material.
Figure 1 presents the flowchart of the construction of the pre-analysis and structuring of
CORPUS for content analysis.
After all the reasoning of the rules and how the researcher will direct their analysis of
content, will proceed the second stage called exploration of the material; to begin the rules
implementation the researcher should develop a new reading of CORPUS.
The CORPUS in this research will be structured in an excel worksheet composed by the
transcription of the answers of the respondents, tables with the registration of RU, CU and
analytical categories according to Bardin technique, analytical categories and evidences
identified with the analysis, registration of the weighted frequencies of the RUs by
category, evaluation of the direction and intensity of the RUs for the NCS KNOWLEDGE category
and a synthesis of saturation/category points that determined the closure of the data
collection.
In the implementation of the CORPUS reading, the RU/category will be cut using the coloured
rule predetermined in the previous step for all the speeches of the subjects interviewed.
The application of the weighted frequency will allow the correct direction of the analysis of
each questioning for the thematic categories and the use of the intensity and direction for
the RUs referring to the NCS KNOWLEDGE category to define the intensity of the right and
wrong answers by the subjects.
The exploration of the material will enable the codification and enumeration of RUs and the
construction of CUs, which is the first significant inference for the analysis of the
subjects' speech and interpretations made by the researcher. Table I shows an example of how
the RU and CU will be organized by analytical category, which is the product of the
exploraion phase of the material.
Figure II represents an example of the flow chart of the implementation of the rules
described above and the beginning of the organization of the evidences that will be
identified until step 2.
In the third stage, called Treatment of the results obtained and interpretation, a revision
of the CU will be implemented, finalizing the construction of it and organizing the main
evidences raised in step 2 to proceed a later interpretation of the results obtained with the
exploration of the material.
In this stage the construction of the table with the categories and a summary of the
evidences that will be submitted to the interpretation of the researcher are going to
completed and will support the construction of the final report of the results and final
discussion of the research in the light of the NCS literature.
