NCT07047625

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

June 24, 2025

Last Update Submit

June 24, 2025

Conditions

Keywords

NephrolithiasisPercutaneous nephrolithotripsyHealth education path

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    Three months

Study Arms (2)

control group

ACTIVE COMPARATOR
Behavioral: control group (Routine nursing)

experimental group

EXPERIMENTAL
Behavioral: Experimental group (Health education path)

Interventions

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

control group

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

experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Fuyang Affiliated Hospital of Anhui Medical University

Fuyang, Anhui, 236000, China

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 2, 2025

Study Start

January 1, 2023

Primary Completion

August 31, 2023

Study Completion

October 1, 2023

Last Updated

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations