- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07436442
THE IMPACT OF NURSİNG CARE ON COMPLİCATİON İN PEG PATİENTS (NCP-PEG)
THE EFFECT OF NURSING CARE ON COMPLICATIONS IN PATIENTS UNDERGOING PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT
This study was conducted to investigate the impact of nursing care on complications in patients undergoing percutaneous endoscopic gastrostomy (PEG) placement.
For the implementation of this randomized controlled study, approval (No: E-46418926-050.99-132774) was obtained from the Ethics Committee of a university on the Anatolian side of Istanbul. The study population comprised all patients who underwent percutaneous endoscopic gastrostomy in the endoscopy unit of the same university hospital between January 3, 2022, and December 16, 2022, while the sample included 60 patients who met the inclusion criteria between April 1, 2022, and December 16, 2022. Data were collected using the Sociodemographic Data Form, Caregiver Information Form, Pre-Procedural Preparation-Before-During Monitoring and Follow-Up Data Form, Post-Percutaneous Endoscopic Gastrostomy Vital Signs, Stoma and Tube Follow-Up Form, and Post-Discharge Home Care Evaluation Form. For statistical analysis of the data obtained from the study, IBM SPSS V22 software was used. The normality of distribution was assessed using the Shapiro-Wilk test. An Independent Samples t-test was applied for comparing normally distributed variables between groups, while the Mann-Whitney U Test was used for non-normally distributed variables. For categorical variables, Yates' Correction, Fisher's Exact Test, and Pearson's Chi-Square Test were used; multiple comparisons were performed using the Bonferroni-corrected Z-test. The analysis results were presented as mean ± standard deviation and median (minimum-maximum) for quantitative variables, and as frequency (percentage) for categorical variables. The level of significance was set at p<0.050.
Keywords: Oral care, Training, Nursing, Complications, Percutaneous endoscopic gastrostomy.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34668
- Sultan 2. Abdulhamid Han Eah
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Agreeing to participate in the study,
- Being over 18 years of age,
- Having sound cognitive abilities,
- Being able to communicate in Turkish,
- Being literate,
- The caregiver not having any communication impediments.
Exclusion Criteria: • Refusing to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Percutaneous Endoscopic Gastrostomy Intervention Group
Patients in the intervention group received customized training from the researcher.
|
Patients in the intervention group received "Specialized Training" from the researcher on the management of percutaneous endoscopic gastrostomy.
Other Names:
|
|
No Intervention: Percutaneous Endoscopic Gastrostomy Control Group
The group that was not interfered with by the researcher.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effect of nursing care on complications in patients undergoing percutaneous endoscopic gastrostomy placement
Time Frame: Patients were monitored during the procedure: 30 minutes, post-PEG: 60 minutes, first dressing change and education: 45 minutes. Evaluation four weeks after discharge: 20 minutes. Data were evaluated after the completion of the study (9 months).
|
Patients in the intervention group who received special education were compared with patients in the control group who did not receive special education in terms of complication rates.
|
Patients were monitored during the procedure: 30 minutes, post-PEG: 60 minutes, first dressing change and education: 45 minutes. Evaluation four weeks after discharge: 20 minutes. Data were evaluated after the completion of the study (9 months).
|
Collaborators and Investigators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sultan 2. Abdulhamid Han EAH
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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