Narrative NursingNCT06175585
Construction of Theoretical Model of Medical Treatment Behavior of Patients With Chronic Kidney Disease
An observational study of Narrative Nursing and Maintenance Hemodialysis, run by Shanxi Medical University at 1 site in China.
Trial summary
The impact of narrative nursing interventions on negative emotions, self-efficacy, quality of life in individuals undergoing maintenance hemodialysis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Narrative Nursing, Maintenance Hemodialysis, Chronic Kidney Diseases
- What is being tested?
- narrative nursing and traditional nursing
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2023to 29 Dec 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing MHD at the Department of Nephrology in our hospital.
Who may be able to join
- Patients diagnosed with ESRD and treated with dialysis for more than 3 months;
- Patients aged ≥18 years old;
- Patients with complete clinical data;
- Patients who are clearly conscious and can accurately express their willingness;
- Patients who have signed informed consent and are willing to cooperate with the study.
Who cannot join
- Patients with other serious systemic diseases, such as severe cardiovascular and cerebrovascular diseases, severe diabetes, etc.;
- Patients with mental disorder, such as cognitive or intellectual disability;
- Patients with a history of anxiety and depression;
- Patients with intermittent loss of consciousness or are unable to understand the questions in the questionnaire.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Zheng Jie, Associate professor, +8618636667799, zhengjie@sxmu.edu.cn
About this study
Official title: Construction of a Theoretical Model of Medical Behavior of Patients With Chronic Kidney Disease From the Perspective of Supply: An Empirical Analysis Based on Andersen Behavior Model
The impact of narrative nursing interventions on negative emotions, self-efficacy, quality of life in individuals undergoing maintenance hemodialysis
Read the detailed description
The objective of this study is to create a narrative nursing protocol using the "two-line system" approach to enhance the practice of narrative nursing.Investigators applied this protocol during maintenance hemodialysis (MHD) treatment, with the aim of examining the impact of the interventions on negative emotions, self-efficacy, and overall quality of life of patients. By analyzing the data before and after the interventions, investigators aim to demonstrate how targeted narrative nursing measures can positively influence negative emotions, self-efficacy, and life quality of patients.
- Being tested
- narrative nursing, traditional nursing
- Keywords
- self-efficacy, negative emotions, life quality
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
narrative nursingOther
The narrative nursing process is based on the practice of "two-line system" proposed by Jiang, which is carried out in a separate classroom, office or ward with sufficient space and good lighting. The environment is set to the right temperature and humidity for comfortable face-to-face conversation. This process is done in stages, depending on how often the patient is dialysis three or more times a week.
Each session lasts about 30 minutes and the whole process lasts four weeks. Adjust to the specific needs of each patient .
traditional nursingOther
Patients undergoing MHD received traditional nursing interventions, encompassing various aspects such as dietary advice, instructions on medication usage, health education, emphasis on precautions during dialysis, and guidelines for vascular access care. Additionally, the nurses proactively inquired about patients' emotional well-being during the nursing shift change, actively engaged and uplifted patients experiencing low spirits, and encouraged family members to provide emotional support.
| Study group | Role | What they receive |
|---|---|---|
| traditional nursing group | Not described Receives: Other: traditional nursing | |
| narrative nursing group | Not described Receives: Other: narrative nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zung's Self-Rating Anxiety Scale
assess the anxiety and depression levels of patients
Measured: one week
Self-rating Depression Scale
assess the anxiety and depression levels of patients
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start29 Nov 2023
- Primary completion29 Nov 2024 (estimated)
- Study completion29 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narrative NursingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Jie, Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175585
- Sponsor's protocol ID
- 2019041044-1
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Theoretical Model of Medical Behavior of Patients With Chronic Kidney Disease From the Perspective of Supply: An Empirical Analysis Based on Andersen Behavior Model
- ClinicalTrials.gov ID
- NCT06175585
- Acronym / sponsor ID
- 2019041044-1
- Keywords
- self-efficacy, negative emotions, life quality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 29 Nov 2024 (estimated)
- Study completion
- 29 Dec 2024 (estimated)
- First posted
- 19 Dec 2023 (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.
The impact of narrative nursing interventions on negative emotions, self-efficacy, quality of life in individuals undergoing maintenance hemodialysis
Detailed description
The objective of this study is to create a narrative nursing protocol using the "two-line system" approach to enhance the practice of narrative nursing.Investigators applied this protocol during maintenance hemodialysis (MHD) treatment, with the aim of examining the impact of the interventions on negative emotions, self-efficacy, and overall quality of life of patients. By analyzing the data before and after the interventions, investigators aim to demonstrate how targeted narrative nursing measures can positively influence negative emotions, self-efficacy, and life quality of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional nursing group | – | Other: traditional nursing |
| narrative nursing group | – | Other: narrative nursing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing MHD at the Department of Nephrology in our hospital.
Key inclusion criteria (5 listed)
- Patients diagnosed with ESRD and treated with dialysis for more than 3 months;
- Patients aged ≥18 years old;
- Patients with complete clinical data;
- Patients who are clearly conscious and can accurately express their willingness;
- Patients who have signed informed consent and are willing to cooperate with the study.
Key exclusion criteria (4 listed)
- Patients with other serious systemic diseases, such as severe cardiovascular and cerebrovascular diseases, severe diabetes, etc.;
- Patients with mental disorder, such as cognitive or intellectual disability;
- Patients with a history of anxiety and depression;
- Patients with intermittent loss of consciousness or are unable to understand the questions in the questionnaire.
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 |
|---|---|---|
| narrative nursingThe narrative nursing process is based on the practice of "two-line system" proposed by Jiang, which is carried out in a separate classroom, office or ward with sufficient space and good lighting. The environment is set to the right temperature and humidity for comfortable face-to-face conversation. This process is done in stages, depending on how often the patient is dialysis three or more times a week. Each session lasts about 30 minutes and the whole process lasts four weeks. Adjust to the specific needs of each patient . | Other | narrative nursing group |
| traditional nursingPatients undergoing MHD received traditional nursing interventions, encompassing various aspects such as dietary advice, instructions on medication usage, health education, emphasis on precautions during dialysis, and guidelines for vascular access care. Additionally, the nurses proactively inquired about patients' emotional well-being during the nursing shift change, actively engaged and uplifted patients experiencing low spirits, and encouraged family members to provide emotional support. | Other | traditional nursing group |
Primary outcome
Zung's Self-Rating Anxiety Scale
Time frame: one week
assess the anxiety and depression levels of patients
Self-rating Depression Scale
Time frame: one week
assess the anxiety and depression levels of patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narrative Nursing and Maintenance Hemodialysis, run by Shanxi Medical University at 1 site in China.
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 5 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 19 Dec 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Zheng, Associate professor (+8618636667799, zhengjie@sxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zung's Self-Rating Anxiety Scale (time frame: one week). The study lists 2 primary outcomes in all. 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 19 Dec 2023.