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Clinical Trials/NCT06712277
NCT06712277
Active, not recruiting
Not Applicable

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

Melike YAZAR1 site in 1 country25 target enrollmentNovember 25, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Having a Percutaneous Endoscopic Gastrostomy
Sponsor
Melike YAZAR
Enrollment
25
Locations
1
Primary Endpoint
caregiver gastrostomy compliance form
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 25, 2024
End Date
March 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Melike YAZAR
Responsible Party
Sponsor Investigator
Principal Investigator

Melike YAZAR

Specialist Nurse

Beykoz State Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

caregiver gastrostomy compliance form

Time Frame: 1-2 month

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.

Secondary Outcomes

  • Care Skills Assessment Form(1-2 month)

Study Sites (1)

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