THE IMPACT OF NURSİNG CARE ON COMPLİCATİON İN PEG PATİENTS

NCT07436442 | Completed

• 1 other identifier: Sultan 2. Abdulhamid Han EAH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Difficulty Swallowing

Keywords

COMPLİCATİON

Outcome Measures

Primary Outcomes (1)

• The effect of nursing care on complications in patients undergoing percutaneous endoscopic gastrostomy placement

  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).

Study Arms (2)

Percutaneous Endoscopic Gastrostomy Intervention Group

EXPERIMENTAL

Patients in the intervention group received customized training from the researcher.

Other: customized training

Percutaneous Endoscopic Gastrostomy Control Group

NO INTERVENTION

The group that was not interfered with by the researcher.

Interventions

customized training OTHER

Patients in the intervention group received "Specialized Training" from the researcher on the management of percutaneous endoscopic gastrostomy.

Also known as: oral care, special education

Percutaneous Endoscopic Gastrostomy Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Sultan 2. Abdulhamid Han Eah

Istanbul, Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Dental Care Team

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Patient Care Team; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd. NURSE

Model Details: According to the research design and sample size calculation, patients who agreed to participate in the study under the same environment and conditions and who met all the inclusion criteria were divided into two groups, intervention and control groups, to determine the effect of the dependent variable. Randomization was performed by assigning a sequence number starting with the nearest endoscopy appointment date. In randomization, each patient participating in the study was given a sequence number from 1, 2, 3, ... to 60. The sequence number assigned to the patient was compared with the numbers in the randomization group list. The patient was assigned to the group whose sequence number matched the number in the randomization list. The random.org program was used for randomization.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 27, 2026
• Study Start: April 3, 2022
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)