The Effect of Video Education on Adaptation to the Procedure of Patients and Caregivers Who Underwent Gastrostomy
Phase: NA
Conditions: Having a Percutaneous Endoscopic Gastrostomy
Sponsor: Melike YAZAR

 
 
 
 
NouS/TncTR
[Kurs başlığı]
STUDY PROTOCOL 
NAME OF THE STUDY: THE EFFECT OF VİDEO EDUCATİON 
ON ADAPTATİON TO THE PROCEDURE OF PATİENTS AND 
CAREGİVERS WHO UNDERWENT GASTROSTOMY.HALİÇ 
UNİVERSİTY   MELİKE YAZAR 04/07/2024 
 

 
 
 
 

 
 
 
 
 

Summary of the Study 
This study will be conducted to investigate the effect of video training given to caregivers of 
patients who underwent percutaneous endoscopic gastrostomy on the compliance of patients 
and caregivers to gastrostomy. It was planned as a single-group quasi-experimental study 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 patients and 
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. The data of the study; Patient Information Form, Caregiver Information Form, 
Caregiver Gastrostomy Adaptation Form, Caregiver Gastrostomy Adaptation Monthly Follow-
up Form, Caregiver Skills Assessment Form, Patient Gastrostomy Adaptation Form, Patient 
Gastrostomy Adaptation Monthly Follow-up Form, Caregiver Feedback Form will be collected. 
SPSS 26 program will be used for statistical analyses. Descriptive statistical methods for data 
and Shapiro Wilks test and Box Plot graphics will be used in the evaluation of distribution. 
Student t test, Oneway Anova test, Bonferroni test and Paired Samples t test will be used for 
variables showing normal distribution, and Mann Whitney U test, Kruskal Wallis test, Dunn 
test and Wilcoxon Signed Rank test will be used for variables not showing normal distribution. 
Pearson or Spearman's correlation analysis, linear regression modeling will be done. Chi-
Square test and Fisher's Exact test will be used for qualitative data. The results will be evaluated 
at a 95% confidence interval and significance at p<0.05. 
Rationale and Purpose of the Study : 
Adequate and balanced nutrition is defined as the adequate intake of all nutrients necessary for 
growth, renewal and maintenance of organ functions, and modulating immune responses 
(McClave et al., 2016; Özbaş, 2018). However, failure to provide nutrition for various reasons, 
i.e. nutritional deficiency, can negatively affect the functioning of many organ systems (Çelebi 
and Yılmaz, 2019). 
Malnutrition damages the patient's muscle strength and immune function, making the patient 
more vulnerable to infections; resulting in prolonged hospital stays, higher rates of hospital 
readmission, and increased healthcare costs (Çelebi and Yılmaz, 2019; Van den Berg et al., 
2021). In order to avoid malnutrition in the patient, nutrition can be administered orally, 
enterally, and parenterally according to the patient's medical condition and needs (Boullata et 
al., 2017; Duzenli et al., 2021). 
Among the enteral feeding types, ‘‘Percutaneous Endoscopic Gastrostomy (PEG)’’ is a more 
accepted and less invasive method for placing a feeding tube in patients with difficulty 
swallowing (Adachi et al., 2018; Arvanitakis et al., 2021). If enteral feeding will be for more 
than 4-6 weeks, the procedure defined as percutaneous endoscopic gastrostomy, which is 
frequently preferred, is the surgical insertion of a tube by directly entering the stomach through 
the abdominal wall (McClave et al., 2016; Kahveci and Çelik, 2020). Patients who undergo this 
procedure need a lot of information on the subject when they are discharged (Kahveci and Çelik; 
2020). The guideline prepared by the European Society for Clinical Nutrition and Metabolism 

(ESPEN) provides information about the application to professionals and home enteral nutrition 
providers (Bischoff et al., 2020; Karaca et al., 2020). Enteral nutrition is an important clinical 
intervention for patients of all ages in various care settings (Boullata et al., 2017). It is also very 
important that this intervention is performed correctly (Kahveci et al.; 2020). 
The most common indications for gastrostomy are head and neck cancer, motor neuron disease, 
other neurological disorders, multiple trauma, and malnutrition (due to postoperative recovery, 
mental retardation, gastrointestinal motility disorders) (Strijbos et al., 2018; Kahveci and Çelik, 
2020). It is known that nutritional support reduces the risk of mortality, pain, and improves 
functional quality of life outcomes in cancer patients (Barbosa et al., 2016; Bargetzi et al., 2021; 
Davies et al., 2021). 
However, if patients are not given sufficient information about percutaneous endoscopic 
gastrostomy care and dressing, the complications that occur or are seen due to the procedure 
are divided into two groups as minor and major complications (Kahveci et al., 2020). 
Minor complications; periostomal infection, periostomal leakage, pneumoperitoneum, bleeding 
and ulceration in the gastrointestinal system, tube obstruction (Friginal-Ruiz and Lucendo, 
2015; Kahveci et al., 2020; Chan et al., 2023). 
Major complications are necrotizing fasciitis, buried bumper syndrome, colocutaneous fistula, 
pulmonary aspiration (Kahveci et al., 2020; Yoshida et al., 2023). In order to prevent 
complications, planned discharge education, home monitoring and home tube care education 
can be given to patients who have undergone gastrostomy and their relatives (Kahveci et al., 
2020; Lima et al., 2023). 
Tube care after percutaneous endoscopic gastrostomy is quite difficult for the patient and their 
relatives (Kahveci et al., 2020; Saka et al., 2021). Continuous education and guidance should 
be provided to patients and their relatives who have undergone percutaneous endoscopic 
gastrostomy procedures regarding device or stoma care, medication administration, monitoring 
of nutritional status, coordination with expert teams for the diagnosis and treatment of 
complications including nutritional problems, assessment of the need for tube change or 
removal, and appropriate continuation of enteral nutrition (Farrah, 2019; Chan et al., 2023). It 
has been demonstrated that the need for information affects the care burden of patients' 
caregivers and increases their anxiety and depression levels (Burgos et al., 2018; Aydar et al., 
2023). 
There is a need for clinical guidelines to assess and protect the health of caregivers, and culture-
specific programs and long-term clinical studies to ensure that caregivers can cope with daily 
life stressors (Ay et al., 2017; Farrag et al., 2019). 
Nurses should collaborate with the patient and their family to alleviate their fears and concerns, 
and include them in the care process (Kahveci et al., 2020). It has been shown that the education 
provided improves outcomes such as caregiver burden, depression, anxiety, and satisfaction 
with care (Davies et al., 2021). 
It has been shown that education given to patients undergoing percutaneous enteral gastrostomy 
via instant messaging increases the patient's self-care ability, improves the social aspects of 
quality of life, and can reduce complications (Hill et al., 2021; Chen et al., 2023). The active 

participation of the patient and caregivers in the training program and the implementation of 
the training make the learning permanent (Ay et al., 2017; Kahveci et al., 2020). 
It is important for the patient's nutritional status and the caregiver's care burden that healthcare 
professionals working in hospitals can provide support to caregivers, plan appropriate 
interventions and evaluate the results of the interventions (Kahveci et al., 2019). 
This study will reveal the necessity of the caregiver participating in the care along with the 
patient and that trainings requiring psychomotor skills should be carried out in a way that 
supports this skill. It is also thought that this training will increase the compliance of caregivers. 
While there are studies in the literature focusing on the care burden and anxiety level of this 
patient group of caregivers, no study focusing on the compliance of the caregiver and the patient 
has been found (Burgos et al., 2018; Davies et al., 2021; Aydar et al., 2023). In this respect, it 
is thought that it will fill the gap in the literature. 
This study will be conducted to investigate the effect of video training given to caregivers of 
patients undergoing percutaneous endoscopic gastrostomy on the compliance of patients and 
caregivers to gastrostomy. It was planned as a single-group quasi-experimental study to 
determine the effect of training on the compliance of patients and caregivers to gastrostomy and 
the caregiver's gastrostomy care skills. 
Method, Tools/Materials to be Used 
Purpose and Type of Study: This study will be conducted to examine the effect of video 
education given to caregivers of patients who underwent percutaneous endoscopic gastrostomy 
on the compliance of patients and caregivers to gastrostomy. It was planned as a single-group 
quasi-experimental study to determine the effect of education on the compliance of patients and 
caregivers to gastrostomy and the caregiver's gastrostomy care skills. 
 
H0: Video education given to caregivers does not increase the compliance of the caregiver and 
patient and the caregiver's gastrostomy care skills. 
 
H1a: Video education given to caregivers ensures the caregiver's compliance with the 
procedure. 
 
H1b: Video education given to caregivers increases the caregiver's care skill level. 
 
H1c: Video education given to caregivers ensures the patient's compliance with the gastrostomy 
tube. 
Place and Time of the Study: This study was planned to be conducted with caregivers who met 
the inclusion criteria for the study and underwent percutaneous endoscopic gastrostomy for the 
first time at the Beykoz State Hospital endoscopy unit between September 1, 2024 and March 
31, 2026. 

Universe and Sample of the Study: The universe of the study will consist of caregivers who met 
the inclusion criteria for the study and underwent percutaneous endoscopic gastrostomy for the 
first time at the Beykoz State Hospital between the dates of the study. Power analysis was 
performed using the G*Power (v3.1.7) program to determine the sample size. The power of the 
study is expressed as 1-β (β = Type II error probability). According to Cohen's effect size 
coefficients; Assuming that the evaluations after the video training to be conducted with 
patients who underwent percutaneous endoscopic gastrostomy at Beykoz State Hospital would 
have a large effect size (d=0.8), it was found that at least 20 people were needed at α=0.05 level 
with 95% power. Considering the losses, it was decided to include 25 people in the study. 
 
Patient Inclusion Criteria: 
Not having cancer, 
Having had a percutaneous endoscopic gastrostomy procedure for the first time. 
Caregiver Inclusion Criteria: 
Being willing to participate in the study, 
Being over 18 years of age, 
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. 
 
Education Booklet : An education video will be created with a patient who has a percutaneous 
endoscopic gastrostomy procedure, for which written and verbal consent has been obtained 
regarding the subjects specified in the education booklet (ANNEX-9) created by the researcher. 
The education video is planned to be 30-45 minutes in line with the literature (Kahveci, 2020; 
Torun, 2023). This education video will be watched by the caregivers and will be sent to their 
phones via the Whatsupp application by the researcher so that they can review it again when 
necessary. In addition, the Education Booklet  will be given to the caregivers after the training. 
The booklet will be finalized by obtaining the opinions of 10 experts regarding the education 
booklet. 
 Data Collection Method: Percutaneous endoscopic gastrostomy procedure is performed on 
patients in the endoscopy unit by appointment. After the procedure, the patients' treatments 
continue in the ward, intensive care unit or at home where they are followed. The appointment 
list will be followed and the researcher will collect face-to-face data from the patient and 
caregivers in the ward where the patient who has undergone percutaneous endoscopic 
gastrostomy for the first time is hospitalized. Patients who are hospitalized in intensive care 
will be included in the study after they are discharged from intensive care. Data will be collected 
by face-to-face interviews with patients and caregivers whose percutaneous endoscopic 

gastrostomy has been opened for the first time and whose verbal and written consents have been 
obtained to participate in the study. 
 
 
Preliminary Application: In order to determine the clarity of the data collection forms to be 
used in the study, a preliminary application will be carried out by the researcher after obtaining 
the necessary institutional and ethics committee permissions. Since the preliminary application 
should be 10% of the sample studied in accordance with the literature, a pilot study will be 
carried out by applying it to three caregivers (Arlı and Nazik, 2001; Torun, 2023). After the 
preliminary application, the necessary corrections will be made and the data collection forms 
and training materials will be finalized.  
Application: The first visit will be carried out in the patient room the next morning following 
the percutaneous endoscopic gastrostomy procedure in accordance with the literature (Kahveci, 
2020; Torun, 2023). Percutaneous endoscopic gastrostomy care training will be given to the 
caregivers of patients who have undergone percutaneous endoscopic gastrostomy for the first 
time by the researcher via video. The video training will be sent to the caregivers' phones via 
the Whatsapp application. At the end of the training, the caregivers' questions will be answered 
and the researcher's contact number will be given to provide consultancy in case of any 
problems that may occur. After the training, the caregivers will be given the training booklet. 
At the first visit, the Patient Information Form, Caregiver Information Form, Caregiver 
Gastrostomy Adaptation Form, and Patient Gastrostomy Adaptation Form will be applied. At 
the 14th and 30th day follow-ups after the first training, the caregivers' questions will be 
answered and the Caregiver Gastrostomy Adaptation Form, and Patient Gastrostomy 
Adaptation Form will be applied by the researcher. The care given to the patients by the 
caregiver will be observed by the researcher on the 14th and 30th day follow-ups and the 
Caregiver Skills Assessment Form will be filled out. When the patients are discharged, the 
Caregiver Skills Assessment Form  will be applied during the home visit.  
Evaluation of Data: SPSS 26 (Statistical Package for the Social Sciences) program will be 
used for statistical analysis 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 to evaluate the conformity of the data 
to normal distribution. Student t test will be used for two-group evaluations of variables 
showing normal distribution; Oneway Anova test will be used for comparisons of three groups 
and above and Bonferroni test will be used to determine the group causing the difference. Paired 
Samples t test will be used for within-group evaluations. In the evaluation of variables that do 
not show normal distribution according to two groups, Mann Whitney U test; Kruskal Wallis 
test will be used in comparisons of three groups and above and Dunn test will be used in 
determining the group causing the difference. Wilcoxon Signed Rank test will be used in 
within-group evaluations. In the evaluation of relationships between variables, Pearson or 
Spearman’s correlation analysis will be used according to the distribution; Linear regression 
modeling will be done in advanced evaluations. 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 the level of p<0.05. 

Determined Study Period: The study is planned to be conducted between September 1, 2024 
and March 31, 2026 and the total duration (1.5 years).  
Ethical Direction: The study will be conducted in accordance with the provisions of the 
Declaration of Helsinki. Ethics committee approval will be obtained from the Haliç University 
Non-Interventional Clinical Research Ethics Committee. In order for this study, which will use 
a quantitative research design, to be conducted at Beykoz State Hospital, an institutional permit 
will be obtained from the Istanbul Provincial Health Directorate. After the ethics committee 
approval, the study will be initiated by obtaining verbal and written consent from patients and 
caregivers who meet the inclusion criteria. 
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