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

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34668
        • Sultan 2. Abdulhamid Han Eah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • oral care
  • special education
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2022

Primary Completion (Actual)

December 16, 2022

Study Completion (Actual)

December 16, 2022

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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