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

NCT ID: NCT06712277

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-25

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Having a Percutaneous Endoscopic Gastrostomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

It was planned as a single-group quasi-experimental study to determine the effect of training on patient and caregiver compliance with gastrostomy and the caregiver's gastrostomy care skills.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patients and caregivers who underwent percutaneous endoscopic gastrostomy for the first time

Group Type EXPERIMENTAL

Video training

Intervention Type OTHER

After the procedure, caregivers will be trained on tube care and patient feeding by demonstrating and performing the procedure on an iPad.

Interventions

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Video training

After the procedure, caregivers will be trained on tube care and patient feeding by demonstrating and performing the procedure on an iPad.

Intervention Type OTHER

Eligibility Criteria

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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.

\-
Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Halic University

OTHER

Sponsor Role collaborator

Melike YAZAR

OTHER

Sponsor Role lead

Responsible Party

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Melike YAZAR

Specialist Nurse

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Melike Yazar

Role: PRINCIPAL_INVESTIGATOR

Beykoz State Hospital Surgical Service Nurse

Locations

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Beykoz State Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Higher Education Institution

Identifier Type: OTHER

Identifier Source: secondary_id

Beykoz State Hospital

Identifier Type: -

Identifier Source: org_study_id