NephrolithiasisNCT07047625
The Application of Health Education Path Nursing Program
A study testing Experimental group （Health education path） in people with Nephrolithiasis, run by Fuyang Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial summary
Objective: To explore the effect of health education pathway on self-management ability and quality of life of patients after percutaneous nephrolithotomy. Method: Patients who underwent renal calculi in our hospital from January 1,2023 to August 31,2023 were collected by convenient sampling method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Experimental group （Health education path）
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with preoperative urinary tract infection received anti-infective treatment and were well controlled;
- The levels of blood pressure, blood glucose and electrolyte abnormalities found before operation returned to normal and remained stable after active treatment by doctors;
- Patients undergoing percutaneous nephrolithotripsy.
Who cannot join
- There were systemic hemorrhagic diseases, and the coagulation function has not been corrected;
- Long-term use of anticoagulant drugs such as aspirin, warfarin, preoperative non withdrawal for more than 1 week;
- Renal malignant tumor, pelvic ectopic kidney, polycystic kidney and severe renal prolapse were found before operation;
- Pregnancy patients;
- Uncontrolled urinary tract infection;
- Infectious disease activity period, such as tuberculosis, hepatitis and other patients.
Trial locations and contacts
1 site in 1 country.
China1 site
the Fuyang Affiliated Hospital of Anhui Medical University
Fuyang, Anhui, 236000
About this study
Official title: The Application Effect of Health Education Path Nursing Program in Patients After Percutaneous Nephrolithotomy
Objective: To explore the effect of health education pathway on self-management ability and quality of life of patients after percutaneous nephrolithotomy. Method: Patients who underwent renal calculi in our hospital from January 1,2023 to August 31,2023 were collected by convenient sampling method. According to the order of enrollment, they were divided into control group and experimental group. Self-management indicators and quality of life indicators were collected for comparison.
- Conditions
- Nephrolithiasis
- Being tested
- control group (Routine nursing), Experimental group （Health education path）
- Keywords
- Nephrolithiasis, Percutaneous nephrolithotripsy, Health education path
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control group (Routine nursing)Behavioural
the implementation of routine treatment and nursing measures, including (1) Monitoring vital signs: according to the condition of vital signs change detection, found abnormal, timely notify the doctor, comply with medical treatment, observe the curative effect. (2) Relieve pain: tell patients the method of distraction, follow the doctor's advice, and observe the curative effect. (3) Improve disease awareness: Inform patients or family members of disease-related knowledge, examination, diagnosis and treatment, surgery and other purposes, significance and precautions. (4) Ensure patient safety: strengthen safety education, strict three check seven pairs, bed placed a variety of safety warning signs. (5) Avoid the occurrence of unexpected risks: guide patients and their families to prevent burns, trauma, etc. (6) Prevention of infection: strict implementation of disinfection and isolation system, the implementation of hand hygiene norms, reduce visits. (7) Raise the affected limb, early f
Experimental group （Health education path）Behavioural
On the basis of the control group, the health education path nursing program was adopted. The specific intervention measures were as follows: ① A program implementation team was set up, including 2 urologists, 2 nurses and 1 psychological counselor. All members have received relevant professional training; ②Two nurses were the main liaisons for the intervention and were responsible for monitoring the treatment and nursing of patients throughout the course. The workflow was as follows: starting from the patient's discomfort experience, the patient was managed according to the nursing procedure steps. By assessing the patient's existing discomfort symptoms, interventional cognitive intervention and psychological intervention, and based on the intervention plan proposed in this study, a health education path nursing plan was developed for patients from the aspects of diet, liquid intake, position adjustment, and symptomatic intervention (see Table 1). In the process of intervention, feedb
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Not described Receives: Behavioral: control group (Routine nursing) |
| experimental group | Experimental | Not described Receives: Behavioral: Experimental group （Health education path） |
What is being measured
The primary outcome is the main question the study is designed to answer.
The self-management ability of the two groups of subjects
The self-management ability refers to the ' self-management ability survey scale for patients with urinary calculi ' in the study of Wang Hongdan et al. The Likert5 score method was used to evaluate the self-management ability of the two groups of patients before and three months after the intervention from the five dimensions of diet control, proper exercise, emotional management, medication compliance and regular follow-up. The total score was 5-25 points. The higher the score, the stronger the patient's self-management ability.
Measured: three months
The quality of life of the two groups of subjects
SF-36 was used as a quality of life questionnaire. It comprehensively summarized the quality of life of respondents from eight aspects: physiological function, physiological function, physical pain, general health status, energy, social function, emotional function and mental health. The higher the score, the better the situation
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Jan 2023
- Primary completion31 Aug 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuyang Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antao Dong, Fuyang Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047625
- Sponsor's protocol ID
- FuyangH002
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application Effect of Health Education Path Nursing Program in Patients After Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT07047625
- Acronym / sponsor ID
- FuyangH002
- Conditions
- Nephrolithiasis
- Keywords
- Nephrolithiasis, Percutaneous nephrolithotripsy, Health education path
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fuyang Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 2 Jul 2025 (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.
Objective: To explore the effect of health education pathway on self-management ability and quality of life of patients after percutaneous nephrolithotomy. Method: Patients who underwent renal calculi in our hospital from January 1,2023 to August 31,2023 were collected by convenient sampling method. According to the order of enrollment, they were divided into control group and experimental group. Self-management indicators and quality of life indicators were collected for comparison.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Behavioral: control group (Routine nursing) |
| experimental group | Experimental | Behavioral: Experimental group （Health education path） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with preoperative urinary tract infection received anti-infective treatment and were well controlled;
- The levels of blood pressure, blood glucose and electrolyte abnormalities found before operation returned to normal and remained stable after active treatment by doctors;
- Patients undergoing percutaneous nephrolithotripsy.
Key exclusion criteria (6 listed)
- There were systemic hemorrhagic diseases, and the coagulation function has not been corrected;
- Long-term use of anticoagulant drugs such as aspirin, warfarin, preoperative non withdrawal for more than 1 week;
- Renal malignant tumor, pelvic ectopic kidney, polycystic kidney and severe renal prolapse were found before operation;
- Pregnancy patients;
- Uncontrolled urinary tract infection;
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 |
|---|---|---|
| control group (Routine nursing)the implementation of routine treatment and nursing measures, including (1) Monitoring vital signs: according to the condition of vital signs change detection, found abnormal, timely notify the doctor, comply with medical treatment, observe the curative effect. (2) Relieve pain: tell patients the method of distraction, follow the doctor's advice, and observe the curative effect. (3) Improve disease awareness: Inform patients or family members of disease-related knowledge, examination, diagnosis and treatment, surgery and other purposes, significance and precautions. (4) Ensure patient safety: strengthen safety education, strict three check seven pairs, bed placed a variety of safety warning signs. (5) Avoid the occurrence of unexpected risks: guide patients and their families to prevent burns, trauma, etc. (6) Prevention of infection: strict implementation of disinfection and isolation system, the implementation of hand hygiene norms, reduce visits. (7) Raise the affected limb, early f | Behavioural | control group |
| Experimental group （Health education path）On the basis of the control group, the health education path nursing program was adopted. The specific intervention measures were as follows: ① A program implementation team was set up, including 2 urologists, 2 nurses and 1 psychological counselor. All members have received relevant professional training; ②Two nurses were the main liaisons for the intervention and were responsible for monitoring the treatment and nursing of patients throughout the course. The workflow was as follows: starting from the patient's discomfort experience, the patient was managed according to the nursing procedure steps. By assessing the patient's existing discomfort symptoms, interventional cognitive intervention and psychological intervention, and based on the intervention plan proposed in this study, a health education path nursing plan was developed for patients from the aspects of diet, liquid intake, position adjustment, and symptomatic intervention (see Table 1). In the process of intervention, feedb | Behavioural | experimental group |
Primary outcome
The self-management ability of the two groups of subjects
Time frame: three months
The self-management ability refers to the ' self-management ability survey scale for patients with urinary calculi ' in the study of Wang Hongdan et al. The Likert5 score method was used to evaluate the self-management ability of the two groups of patients before and three months after the intervention from the five dimensions of diet control, proper exercise, emotional management, medication compliance and regular follow-up. The total score was 5-25 points. The higher the score, the stronger the patient's self-management ability.
The quality of life of the two groups of subjects
Time frame: Three months
SF-36 was used as a quality of life questionnaire. It comprehensively summarized the quality of life of respondents from eight aspects: physiological function, physiological function, physical pain, general health status, energy, social function, emotional function and mental health. The higher the score, the better the situation
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 2 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Nephrolithiasis
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
Not yet recruitingEarly Phase 1
Phosphate & Kidney Stones
Kidney Stones, Calcium Oxalate Kidney Stones
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group （Health education path） in people with Nephrolithiasis, run by Fuyang Affiliated Hospital of Anhui 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 3 inclusion and 6 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 2 Jul 2025. 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?
The self-management ability of the two groups of subjects (time frame: three months). 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 2 Jul 2025.