- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05980741
Exploration of New Nursing Models for Urological Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hubei
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Wuhan, Hubei, China, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
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.
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|
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Experimental: study group High-quality nursing
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.
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High-quality nursing
Other Names:
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Experimental: study group Clinical Care Pathway
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.
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Clinical Care Pathway
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Experimental: study group Roy Adaptation Model
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.
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Roy Adaptation Model
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients' quality of life after surgery
Time Frame: 3 months
|
the 36-Item Short Form Health Survey (SF-36)
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3 months
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Patient satisfaction
Time Frame: 3 months
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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
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3 months
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Postoperative complications
Time Frame: 3 months
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Postoperative complications include hemorrhage, infection, and anuria
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3 months
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The postoperative time to flatus
Time Frame: 1 month
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postoperative recovery 1
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1 month
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|
the time for first bowel movement
Time Frame: 1 month
|
postoperative recovery 2
|
1 month
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the length of hospital stay
Time Frame: 1 month
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postoperative recovery 3
|
1 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: E-Jun Peng, Dr., Tong Ji Hospital, Tong Medical College, Huazhong University of Science and Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TJ-IRB20220940
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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