Clinical trial NCT06712277: The Effect of Video Education on Adaptation to the Procedure of Patients and Caregivers Who Underwent Gastrostomy
Official title: The Effect of Video Education on Adaptation to the Procedure of Patients and Caregivers Who Underwent Gastrostomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Having a Percutaneous Endoscopic Gastrostomy
Keywords: patients
percutaneous endoscopic gastrostomi
education
Lead sponsor: Beykoz State Hospital
Sponsor class: OTHER
Collaborators: name: Halic University
First posted: 2024-12-02
Enrollment: 25
Sex: ALL
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.


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.

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Primary outcomes:
measure: caregiver gastrostomy compliance form
timeFrame: 1-2 month
Secondary outcomes:
measure: Care Skills Assessment Form
timeFrame: 1-2 month
Other outcomes:
measure: Patient Gastrostomy Compliance Form
timeFrame: 1-2 month
Locations:
city: Istanbul
country: Turkey
facility: Beykoz State Hospital
Study officials:
affiliation: Beykoz State Hospital Surgical Service Nurse
name: Melike Yazar
role: PRINCIPAL_INVESTIGATOR
References: