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NCT Number: NCT06712277

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.

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Key information

Age range

Up to 95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beykoz State Hospital

Istanbul, 34800, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

video training

Other

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

Primary outcomes

  1. 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

  1. Care Skills Assessment Form

    Time frame: 1-2 month

    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.

Other outcomes

  1. Patient Gastrostomy Compliance Form

    Time frame: 1-2 month

    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.

Sponsors and collaborators

Lead sponsor

Melike YAZAR

Other

Collaborators

  • Halic University

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.