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

NCT06712277 | Active Not Recruiting DMC

• 2 other identifiers: Beykoz State HospitalHigher Education Institution
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Having a Percutaneous Endoscopic Gastrostomy

Keywords

patients; percutaneous endoscopic gastrostomi; education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Care Skills Assessment Form

  1-2 month

Other Outcomes (1)

• Patient Gastrostomy Compliance Form

  1-2 month

Study Arms (1)

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

EXPERIMENTAL

Other: Video training

Interventions

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.

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

Eligibility Criteria

• Age: Up to 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Melike YAZAR: lead
• Halic University: collaborator

Study Sites (1)

Beykoz State Hospital

Istanbul, 34800, Turkey (Türkiye)

Location

Study Officials

• Melike Yazar

  Beykoz State Hospital Surgical Service Nurse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist Nurse

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 2, 2024
• Study Start: November 25, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)