Nurse-Patient RelationsNCT06429592
Stress and Satisfaction Levels of Mothers According to Neuman's Systems Model on Stress and Satisfaction Levels of Mothers With Children in the Intensive Care Unit and Effective Decision Making
An observational study of Nurse-Patient Relations, run by TC Erciyes University.
Trial summary
Research; It will be carried out to examine the effect of the empowerment program structured according to the Neuman systems model on the stress and satisfaction levels and effective decision-making of mothers whose children are in the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nurse-Patient Relations
- What is being tested?
- education
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 17 May 2024to 15 Oct 2024
- How long will I take part?
- 5 Days
- Phase
- Observational
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Mothers who want to voluntarily participate in the research
Who may be able to join
- Research Inclusion Criteria;
- Communicable,
- Mothers whose children are admitted to the intensive care unit,
- Mother must be over 18 years old
- The child has a biological mother
- Mothers who agreed to participate in the study and signed written consent forms,
- The child's intensive care stay must be at least 5 days.
Who cannot join
- Criteria for Exclusion from the Study
- Wanting to leave the study,
- The child must have left the intensive care unit less than 5 days ago,
- The mother is under 18 years of age.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of the Empowerment Program Constructed According to Neuman's Systems Model on Stress and Satisfaction Levels of Mothers With Children in the Intensive Care Unit and Effective Decision Making
Research; It will be carried out to examine the effect of the empowerment program structured according to the Neuman systems model on the stress and satisfaction levels and effective decision-making of mothers whose children are in the intensive care unit.
Read the detailed description
For pediatric nurses, supporting families, especially mothers, who take a primary role in care, increasing their ability to cope with the stress they experience, helping them access the information and resources they need, and supporting family functionality are vital parts of nursing care.
In order to strengthen the family, the relationship between the nurse and the family must be based on respect and trust. In the nurse's communication with the family; The family should discuss the expectations of the family, discuss their views, and care about how much the family wants to be involved in care and what they want to do. Communication provided through these foundations helps to establish a trusting relationship between the family and the nurse and to determine boundaries with the parents. In this way, role confusion between the nurse and parent can be prevented and bidirectional satisfaction can be achieved.
Another issue required to strengthen the family is to establish a close physical and emotional bond between the nurse and the family. This bond is related to the family feeling close enough to the nurse to open up to them not only in the presence of the problem, but also outside the problems. Thus, the family's trust in the nurse increases, removing the nurse from the position of healthcare personnel only caring for the child. Thanks to this special bond the nurse establishes with the family, it makes it easier for family members to express themselves and can even help them discover their weaknesses that they are not aware of. In addition, the nurse evaluates the family's coping methods, helps reveal their strengths, and can ensure more effective planning of care. Studies have shown that as a result of the empowerment programs applied by nurses to families, parents' depression and stress levels decrease, family function, self-efficacy, autonomy, problem-solving skills and family members' support for each other increases.
In order to strengthen the family, it is of great importance to reduce the effects of internal and external stressors, holistic approach, increase the patient's perceptions and motivation, interact with the environment, reach, protect and maintain optimal health. In line with this purpose, the conceptual framework of nursing theories and models forms the basis and directs nursing education, management, practice and nursing research. These components are also included in the philosophical basis of the Neuman Systems Model. Neuman Systems Model is a model that focuses on human needs and emphasizes human uniqueness. It focuses on the multidimensional evaluation of the individual from a holistic perspective in achieving optimal health/well-being. However, accepting that the human being is a biopsychosocial being, it attaches importance to environmental stress and the health of the patient system that reacts to this stress. In Neuman's Systems Model, it is stated that when an individual is exposed to various stressors, his defense system is affected and the individual needs help to protect his basic structure.
It is thought that nursing care structured in line with the Neuman Systems Model facilitates family and child-centered care practice. This study will be conducted to examine the effect of the empowerment program structured according to the Neuman systems model on the stress and satisfaction levels and effective decision-making of mothers whose children are in the intensive care unit.
- Conditions
- Nurse-Patient Relations
- Being tested
- education
- Keywords
- Mother, Pediatric intensive care, Effective decision making, Satisfaction, Stres
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationOther
nursing care practice
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Data collection tools for mothers in the experimental group after acceptance of admission to the intensive care unit [Descriptive Characteristics Form, Parental Stress Scale: (Pediatric Intensive Care Unit), Empowerment of Parents in The Intensive Care (EMPATHIC-30) (Empowerment of Parents in Intensive Care Scale), Decision Data will be collected using the Conflict in Making and Decision Making Confident Scale (KVÇS and KEOÖ). The prepared strengthening program will be applied for a total of 5 days starting from the first day of hospitalization. While the mothers are being treated, no other treatment will be done in the unit.
Different time slots will be scheduled for each experiment. After the 5th day of the application was completed, data collection tools were used. Receives: Other: education | |
| control group | Data collection tools from mothers in the control group after admission to the intensive care unit [Descriptive Characteristics Form, Parental Stress Scale: (Pediatric Intensive Care Unit), Empowerment of Parents in The Intensive Care (EMPATHIC-30) (Empowerment of Parents in Intensive Care Scale), Decision Data will be collected using the Conflict in Making and Decision Making Confident Scale (KVÇS and KEOÖ). The routine operation of the intensive care unit will continue and data will be collected again after 5 days of hospitalization. Receives: Other: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mothers' stress levels and satisfaction levels will be evaluated.
For mothers in the experimental group, data will be collected with data collection tools after acceptance of admission to the intensive care unit. The prepared strengthening program will be applied for a total of 5 days starting from the first day of hospitalization. While the treatments are being carried out to the mothers, no other treatments will be performed in the unit.
Different time slots will be scheduled for each experiment. After the 5th day of the application is completed, data will be collected with data collection tools and mothers' stress levels and satisfaction levels will be evaluated.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start17 May 2024 (estimated)
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse-Patient RelationsStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsah Ogul, TC Erciyes University
- Investigators
- oznur basdas, professor, Study director, erciyes universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429592
- Sponsor's protocol ID
- gulsahogulerciyes4023640013
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Empowerment Program Constructed According to Neuman's Systems Model on Stress and Satisfaction Levels of Mothers With Children in the Intensive Care Unit and Effective Decision Making
- ClinicalTrials.gov ID
- NCT06429592
- Acronym / sponsor ID
- gulsahogulerciyes4023640013
- Conditions
- Nurse-Patient Relations
- Keywords
- Mother, Pediatric intensive care, Effective decision making, Satisfaction, Stres
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 17 May 2024 (estimated)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 28 May 2024 (actual)
- 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.
Research; It will be carried out to examine the effect of the empowerment program structured according to the Neuman systems model on the stress and satisfaction levels and effective decision-making of mothers whose children are in the intensive care unit.
Detailed description
For pediatric nurses, supporting families, especially mothers, who take a primary role in care, increasing their ability to cope with the stress they experience, helping them access the information and resources they need, and supporting family functionality are vital parts of nursing care.
In order to strengthen the family, the relationship between the nurse and the family must be based on respect and trust. In the nurse's communication with the family; The family should discuss the expectations of the family, discuss their views, and care about how much the family wants to be involved in care and what they want to do. Communication provided through these foundations helps to establish a trusting relationship between the family and the nurse and to determine boundaries with the parents. In this way, role confusion between the nurse and parent can be prevented and bidirectional satisfaction can be achieved.
Another issue required to strengthen the family is to establish a close physical and emotional bond between the nurse and the family. This bond is related to the family feeling close enough to the nurse to open up to them not only in the presence of the problem, but also outside the problems. Thus, the family's trust in the nurse increases, removing the nurse from the position of healthcare personnel only caring for the child. Thanks to this special bond the nurse establishes with the family, it makes it easier for family members to express themselves and can even help them discover their weaknesses that they are not aware of. In addition, the nurse evaluates the family's coping methods, helps reveal their strengths, and can ensure more effective planning of care. Studies have shown that as a result of the empowerment programs applied by nurses to families, parents' depression and stress levels decrease, family function, self-efficacy, autonomy, problem-solving skills and family members' support for each other increases.
In order to strengthen the family, it is of great importance to reduce the effects of internal and external stressors, holistic approach, increase the patient's perceptions and motivation, interact with the environment, reach, protect and maintain optimal health. In line with this purpose, the conceptual framework of nursing theories and models forms the basis and directs nursing education, management, practice and nursing research. These components are also included in the philosophical basis of the Neuman Systems Model. Neuman Systems Model is a model that focuses on human needs and emphasizes human uniqueness. It focuses on the multidimensional evaluation of the individual from a holistic perspective in achieving optimal health/well-being. However, accepting that the human being is a biopsychosocial being, it attaches importance to environmental stress and the health of the patient system that reacts to this stress. In Neuman's Systems Model, it is stated that when an individual is exposed to various stressors, his defense system is affected and the individual needs help to protect his basic structure.
It is thought that nursing care structured in line with the Neuman Systems Model facilitates family and child-centered care practice. This study will be conducted to examine the effect of the empowerment program structured according to the Neuman systems model on the stress and satisfaction levels and effective decision-making of mothers whose children are in the intensive care unit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Other: educationData collection tools for mothers in the experimental group after acceptance of admission to the intensive care unit [Descriptive Characteristics Form, Parental Stress Scale: (Pediatric Intensive Care Unit), Empowerment of Parents in The Intensive Care (EMPATHIC-30) (Empowerment of Parents in Intensive Care Scale), Decision Data will be collected using the Conflict in Making and Decision Making Confident Scale (KVÇS and KEOÖ). The prepared strengthening program will be applied for a total of 5 days starting from the first day of hospitalization. While the mothers are being treated, no other treatment will be done in the unit. Different time slots will be scheduled for each experiment. After the 5th day of the application was completed, data collection tools were used. |
| control group | – | Other: educationData collection tools from mothers in the control group after admission to the intensive care unit [Descriptive Characteristics Form, Parental Stress Scale: (Pediatric Intensive Care Unit), Empowerment of Parents in The Intensive Care (EMPATHIC-30) (Empowerment of Parents in Intensive Care Scale), Decision Data will be collected using the Conflict in Making and Decision Making Confident Scale (KVÇS and KEOÖ). The routine operation of the intensive care unit will continue and data will be collected again after 5 days of hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Mothers who want to voluntarily participate in the research
Key inclusion criteria (7 listed)
- Research Inclusion Criteria;
Key exclusion criteria (4 listed)
- Criteria for Exclusion from the Study
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 |
|---|---|---|
| educationnursing care practice | Other | control group, experimental group |
Primary outcome
Mothers' stress levels and satisfaction levels will be evaluated.
Time frame: 3 months
For mothers in the experimental group, data will be collected with data collection tools after acceptance of admission to the intensive care unit. The prepared strengthening program will be applied for a total of 5 days starting from the first day of hospitalization. While the treatments are being carried out to the mothers, no other treatments will be performed in the unit. Different time slots will be scheduled for each experiment. After the 5th day of the application is completed, data will be collected with data collection tools and mothers' stress levels and satisfaction levels will be evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
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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.
oznur basdas, professor study director
erciyes universitesi
Questions about this trial
What is this clinical trial studying?
An observational study of Nurse-Patient Relations, run by TC Erciyes University.
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 7 inclusion and 4 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 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GULSAH OGUL (6177507711, gulsahogul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mothers' stress levels and satisfaction levels will be evaluated. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2024.