Urological NursingNCT05980741
Exploration of New Nursing Models for Urological Surgery
A study testing high-quality nursing, Clinical Care Pathway and Roy Adaptation Model in people with Urological Nursing, run by YaNi Peng at 1 site in China.
Trial summary
Patients undergoing urological surgery often need to be provided with targeted nursing care to ensure that the therapeutic effects can be fully realized, however, the traditional nursing cannot reach the expect effect.both patient outcome and nurse satisfaction have been reported with high levels of dissatisfaction in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urological Nursing
- What is being tested?
- high-quality nursing, Clinical Care Pathway and Roy Adaptation Model
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with a definite diagnosis of urological disease confirmed by pathological examination or imaging;
- patients with definite surgical indications;
- patients with complete follow-up information.
Who cannot join
- patients with hepatic or renal dysfunction or serious organic lesions in other organs;
- patients with associated lymph node and distant metastases;
- patients who withdrew during the study;
- patients with incomplete case and follow-up data.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Patients undergoing urological surgery often need to be provided with targeted nursing care to ensure that the therapeutic effects can be fully realized, however, the traditional nursing cannot reach the expect effect.both patient outcome and nurse satisfaction have been reported with high levels of dissatisfaction in the traditional nursing. Therefore, exploring a new, patient-centered and effective nursing mode is needed. In 2010, the Chinese Ministry of Health proposed a project named the High-Quality Care Project to improve nurse and patient outcomes through the transformation of the nursing care delivery system in hospitals. This study aims to compare the new nursing model and the traditional nursing, and to explore a more effective nursing model for urological surgery.
Read the detailed description
Patients who underwent urological disease diagnosed and treated in our department were included in this study. The patients were randomly divided into two groups through the random number table method, with a 1:1 ratio. The control group received traditional urological care. The study group comprised 3 subgroups, and each subgroup received different nursing model. All the three new nursing models, including high-quality nursing (primary nursing), Clinical care pathway, and Roy adaptation model.were given to the subgroups respectively.
High-quality nursing refers to effective nursing measures in multiple aspects and dimensions, provided to patients according to their actual conditions by centering on the patients throughout their ongoing treatment, strengthening the primary nursing care, and fully implementing the nursing responsibility including managing complications and providing long-term support and information, to ensure patient satisfaction and to improve the patient's quality of life. Clinical care pathway includes multidisciplinary care plans that provides detailed guidelines for patients with specific clinical problems, and the Roy adaptation model (RAM), proposed by nursing scientist Sister Callista Roy in 1970, offers a comprehensive framework to guide nursing care for patients with chronic diseases.
- Conditions
- Urological Nursing
- Being tested
- high-quality nursing, Clinical Care Pathway, Roy Adaptation Model
- Keywords
- High-quality nursing, Primary nursing, Roy Adaptation Model, Urological surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-quality nursingProcedure or surgery
Also called primary nursing
High-quality nursing
Clinical Care PathwayProcedure or surgery
Clinical Care Pathway
Roy Adaptation ModelProcedure or surgery
Roy Adaptation Model
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Traditional nursing services are provided to the control group, based on functional nursing. The nurses in the ward are assigned to complete different tasks according to their responsibilities, technical knowledge and skills. These tasks are including carrying out health education to the patients, introducing the admission guidelines and ward conditions, informing patients of basic knowledge on diseases, treatment, and nursing, monitoring patient vital signs and so on. The basic medical inspection and care are conducted appropriately. The patients are instructed on the compliance and precautions required during the perioperative period. The wound and drainage are checked regularly after the operation. |
| study group High-quality nursing | Experimental | High-quality nursing is provided to the study group based on primary nursing. Nurses in primary nursing take responsibility for the total care of a patient and are accountable for his/her care over 24 h a day from the patient's admission to discharge. In this case, nurses have more time to communicate with patients and to establish the nurse-patient relationship. In addition, high-quality nursing offers effective nursing measures to patients in terms of multiple aspects and dimensions through planning patient-centered nursing care, strengthening the perioperative nursing since admission, and fully implementing the nursing responsibility system. Receives: Procedure: high-quality nursing |
| study group Clinical Care Pathway | Experimental | The clinical care pathway will be implemented immediately after admission. With the patient as the center of the nursing intervention, a flowable form is chosen to ensure that patients could receive effective nursing interventions throughout the entire hospitalization from the day of admission to the final discharge. In addition to primary care, the present program also unifies the management of nursing resources with the establishment of a highly qualified and professionally competent nursing team. The team members would cooperate with each other and give full play to their respective initiatives, with the common goal of improving the quality of care. The severity of illness, psychological status, and family and social environment in each patient differ, so individualized care plans are developed for each case. Receives: Procedure: Clinical Care Pathway |
| study group Roy Adaptation Model | Experimental | the Roy Adaptation Model (RAM) offers a comprehensive framework to guide nursing care for patients with chronic diseases. The RAM group receives standard care supplemented with interventions based on the RAM model. Negative emotions measured by the Hospital Anxiety and Depression Scale (HADS), pain intensity by the Visual Analog Scale (VAS), and HRQoL by the 36-Item Short Form Health Survey (SF-36) are measured at the preoperative visit (T0), at 30 days (T1), and at 3 months of (T2) follow-up. Receives: Procedure: Roy Adaptation Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' quality of life after surgery
the 36-Item Short Form Health Survey (SF-36)
Measured: 3 months
Patient satisfaction
The patient satisfaction was evaluated by means of an adapted version of Press-Ganey PS scores, which included physician-specific questions and hospital performance questions
Measured: 3 months
Postoperative complications
Postoperative complications include hemorrhage, infection, and anuria
Measured: 3 months
The postoperative time to flatus
postoperative recovery 1
Measured: 1 month
the time for first bowel movement
postoperative recovery 2
Measured: 1 month
the length of hospital stay
postoperative recovery 3
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Jan 2020
- Primary completion31 Jan 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urological 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- High-quality nursing will be provided to the study group based on primary nursing
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- YaNi Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YaNi Peng, Tongji Hospital
- Investigators
- E-Jun Peng, Dr., Principal investigator, Tong Ji Hospital, Tong Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980741
- Sponsor's protocol ID
- TJ-IRB20220940
- Status last verified
- Aug 2023
- First submitted
- 19 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of New Nursing Models for Urological Surgery
- ClinicalTrials.gov ID
- NCT05980741
- Acronym / sponsor ID
- TJ-IRB20220940
- Conditions
- Urological Nursing
- Keywords
- High-quality nursing, Primary nursing, Roy Adaptation Model, Urological surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- YaNi PengUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 8 Aug 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.
Patients undergoing urological surgery often need to be provided with targeted nursing care to ensure that the therapeutic effects can be fully realized, however, the traditional nursing cannot reach the expect effect.both patient outcome and nurse satisfaction have been reported with high levels of dissatisfaction in the traditional nursing. Therefore, exploring a new, patient-centered and effective nursing mode is needed. In 2010, the Chinese Ministry of Health proposed a project named the High-Quality Care Project to improve nurse and patient outcomes through the transformation of the nursing care delivery system in hospitals. This study aims to compare the new nursing model and the traditional nursing, and to explore a more effective nursing model for urological surgery.
Detailed description
Patients who underwent urological disease diagnosed and treated in our department were included in this study. The patients were randomly divided into two groups through the random number table method, with a 1:1 ratio. The control group received traditional urological care. The study group comprised 3 subgroups, and each subgroup received different nursing model. All the three new nursing models, including high-quality nursing (primary nursing), Clinical care pathway, and Roy adaptation model.were given to the subgroups respectively.
High-quality nursing refers to effective nursing measures in multiple aspects and dimensions, provided to patients according to their actual conditions by centering on the patients throughout their ongoing treatment, strengthening the primary nursing care, and fully implementing the nursing responsibility including managing complications and providing long-term support and information, to ensure patient satisfaction and to improve the patient's quality of life. Clinical care pathway includes multidisciplinary care plans that provides detailed guidelines for patients with specific clinical problems, and the Roy adaptation model (RAM), proposed by nursing scientist Sister Callista Roy in 1970, offers a comprehensive framework to guide nursing care for patients with chronic diseases.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- High-quality nursing will be provided to the study group based on primary nursing
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Traditional nursing services are provided to the control group, based on functional nursing. The nurses in the ward are assigned to complete different tasks according to their responsibilities, technical knowledge and skills. These tasks are including carrying out health education to the patients, introducing the admission guidelines and ward conditions, informing patients of basic knowledge on diseases, treatment, and nursing, monitoring patient vital signs and so on. The basic medical inspection and care are conducted appropriately. The patients are instructed on the compliance and precautions required during the perioperative period. The wound and drainage are checked regularly after the operation. |
| study group High-quality nursing | Experimental | Procedure: high-quality nursingHigh-quality nursing is provided to the study group based on primary nursing. Nurses in primary nursing take responsibility for the total care of a patient and are accountable for his/her care over 24 h a day from the patient's admission to discharge. In this case, nurses have more time to communicate with patients and to establish the nurse-patient relationship. In addition, high-quality nursing offers effective nursing measures to patients in terms of multiple aspects and dimensions through planning patient-centered nursing care, strengthening the perioperative nursing since admission, and fully implementing the nursing responsibility system. |
| study group Clinical Care Pathway | Experimental | Procedure: Clinical Care PathwayThe clinical care pathway will be implemented immediately after admission. With the patient as the center of the nursing intervention, a flowable form is chosen to ensure that patients could receive effective nursing interventions throughout the entire hospitalization from the day of admission to the final discharge. In addition to primary care, the present program also unifies the management of nursing resources with the establishment of a highly qualified and professionally competent nursing team. The team members would cooperate with each other and give full play to their respective initiatives, with the common goal of improving the quality of care. The severity of illness, psychological status, and family and social environment in each patient differ, so individualized care plans are developed for each case. |
| study group Roy Adaptation Model | Experimental | Procedure: Roy Adaptation Modelthe Roy Adaptation Model (RAM) offers a comprehensive framework to guide nursing care for patients with chronic diseases. The RAM group receives standard care supplemented with interventions based on the RAM model. Negative emotions measured by the Hospital Anxiety and Depression Scale (HADS), pain intensity by the Visual Analog Scale (VAS), and HRQoL by the 36-Item Short Form Health Survey (SF-36) are measured at the preoperative visit (T0), at 30 days (T1), and at 3 months of (T2) follow-up. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with a definite diagnosis of urological disease confirmed by pathological examination or imaging;
- patients with definite surgical indications;
- patients with complete follow-up information.
Key exclusion criteria (4 listed)
- patients with hepatic or renal dysfunction or serious organic lesions in other organs;
- patients with associated lymph node and distant metastases;
- patients who withdrew during the study;
- patients with incomplete case and follow-up data.
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 |
|---|---|---|
| high-quality nursingAlso: primary nursingHigh-quality nursing | Procedure or surgery | study group High-quality nursing |
| Clinical Care PathwayClinical Care Pathway | Procedure or surgery | study group Clinical Care Pathway |
| Roy Adaptation ModelRoy Adaptation Model | Procedure or surgery | study group Roy Adaptation Model |
Primary outcome
Patients' quality of life after surgery
Time frame: 3 months
the 36-Item Short Form Health Survey (SF-36)
Patient satisfaction
Time frame: 3 months
The patient satisfaction was evaluated by means of an adapted version of Press-Ganey PS scores, which included physician-specific questions and hospital performance questions
Postoperative complications
Time frame: 3 months
Postoperative complications include hemorrhage, infection, and anuria
The postoperative time to flatus
Time frame: 1 month
postoperative recovery 1
the time for first bowel movement
Time frame: 1 month
postoperative recovery 2
the length of hospital stay
Time frame: 1 month
postoperative recovery 3
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 8 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Urological Nursing
Recruiting
Structured Periprocedural Nursing Interventions in Men Undergoing Transrectal Prostate Biopsy
Anxiety, Biopsy
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.
E-Jun Peng, Dr. principal investigator
Tong Ji Hospital, Tong Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-quality nursing, Clinical Care Pathway and Roy Adaptation Model in people with Urological Nursing, run by YaNi Peng 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 3 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: finished, as of the sponsor's last update on 8 Aug 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?
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?
Patients' quality of life after surgery (time frame: 3 months). The study lists 6 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 8 Aug 2023.