The Effect of Video Education on Adaptation to the Procedure of Patients and Caregivers Who Underwent Gastrostomy

This study will be conducted to investigate the effects of video training given to caregivers of patients who underwent percutaneous endoscopic gastrostomy on the compliance of patients and caregivers to gastrostomy. A single-group quasi-experimental study was planned to determine the effect of training on the compliance of patients and caregivers to gastrostomy and the caregiver's gastrostomy care skills. The universe of the study will consist of caregivers who met the inclusion criteria for the study in which gastrostomy procedure was performed for the first time at Beykoz State Hospital between the dates of September 1, 2024 and March 31, 2026. G*Power power analysis was performed to determine the sample size. According to Cohen's effect size coefficients; according to the calculation made assuming that it will have a large effect size (d=0.8), it was decided that there should be at least 20 people with α=0.05 level, 95% power; considering the losses, it was decided to include 25 people in the study. Statistical Package for the Social Sciences 26 program will be used for statistical analyses of the data obtained from the study. While evaluating the study data, descriptive statistical methods (mean, standard deviation, median, frequency and ratio) as well as Shapiro Wilks test and Box Plot graphics will be used in the evaluation of the distribution of the data. Student t test, Oneway Anova test will be used in the evaluation of variables showing normal distribution and Bonferroni test will be used in the determination of the group causing the difference. Paired Samples t test will be used in the evaluations within the groups. Mann Whitney U test, Kruskal Wallis test will be used in the evaluations of variables not showing normal distribution and Dunn test will be used in the determination of the group causing the difference. Wilcoxon Signed Rank test will be used in the evaluations within the groups. Pearson or Spearman's correlation analysis, linear regression modeling will be done in the evaluation of variables. Chi-Square test and Fisher's Exact test will be used in the comparison of qualitative data. The results will be evaluated at a confidence interval of 95% and significance at p<0.05.

Study Overview

• Status: Active, not recruiting
• Conditions: Having a Percutaneous Endoscopic Gastrostomy
• Intervention / Treatment: Other: Video training

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34800
    • Beykoz State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Having undergone percutaneous endoscopic gastrostomy for the first time. Not having cancer. -

Exclusion Criteria:

Being over 18 years old, Being able to communicate in Turkish, Being able to read and write, The caregiver will be involved in the percutaneous endoscopic gastrostomy care of their patient.

Not being a healthcare professional.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients and caregivers who underwent percutaneous endoscopic gastrostomy for the first time	Other: Video training; After the procedure, caregivers will be trained on tube care and patient feeding by demonstrating and performing the procedure on an iPad.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
caregiver gastrostomy compliance form	It consists of 5 questions that allow the caregiver to express their concerns and troubles while feeding, dressing the tube, giving medication, positioning, and giving body care/bathing to the patient due to the procedure with a value between 0 and 10. The caregiver can get the lowest score from this form: 0, the highest score: 50. A score of 0 from the Caregiver Gastrostomy Adaptation Form indicates that there is no adaptation to gastrostomy, and a score of 50 indicates that there is adaptation to gastrostomy. The form will be finalized after receiving the opinions of 10 experts on the form.	1-2 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Care Skills Assessment Form	It consists of 29 questions measuring care skills, which was created by the researcher in line with the literature in order to evaluate the effectiveness of the training given to the caregivers of the patient with percutaneous endoscopic gastrostomy. The first 27 questions in the care skill evaluation form are worth Yes: 2 points, No: 0 points, Partially: 1 point. 54 points were determined as the highest skill score, 0 points as the lowest skill score. Questions 28 and 29 were created for the evaluation of dressing. The Caregiver Skill Evaluation Form will be filled out by the researcher during the home visit by observing the caregivers on the 14th and 30th day follow-ups. The form will be finalized after receiving the opinions of 10 experts on the form.	1-2 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Gastrostomy Compliance Form	It was created by the researcher to question the complications that may occur in the patient, the reason for hospitalization and readmission. The form created by the researcher in line with the literature consists of 18 questions (Kahveci, 2020; Torun, 2023). It will be scored as Yes: 1, No: 0. High scores will indicate incompatibility. The form will be finalized after receiving the opinions of 10 experts on the form.	1-2 month

Collaborators and Investigators

• Sponsor: Melike YAZAR
• Collaborators: Halic University
• Investigators: Principal Investigator: Melike Yazar, Beykoz State Hospital Surgical Service Nurse

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Estimated): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: patients; education; percutaneous endoscopic gastrostomi
• Other Study ID Numbers: Beykoz State Hospital; Higher Education Institution (Other Identifier: Higher Education Institution)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data collection phase has not been completed yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No