About this trial
Background: Percutaneous endoscopic gastrostomy (PEG) is used for patients who cannot be fed orally, have a reduced swallowing reflex, or require long-term feeding. PEG care and feeding, which is performed with nursing support in healthcare institutions, becomes the responsibility of the caregiver after discharge. During this process, a lack of information and insufficient mastery of PEG feeding can create stress for caregivers. This situation jeopardizes patient safety. Therefore, healthcare professionals should manage patient-centered care from the moment the PEG indication is established until discharge. In this regard, consistent guidance and healthcare education are needed for caregivers.
Aim and hypotheses: This study aims to examine the effects of hands-on PEG feeding and PEG care training, enriched with audiovisual materials (video), on caregivers' knowledge level, skills, and stress levels related to the PEG feeding and care process.
H1: The training provided for caregivers increases their knowledge level regarding PEG feeding and care.
H2: The training provided for caregivers increases their skill level regarding PEG feeding and care.
H3: The training provided for caregivers reduces their stress levels related to PEG feeding and care.
Design: This study was designed as a randomized controlled trial with experimental and control groups.
Method: The study population will consist of caregivers of patients receiving inpatient care at a state hospital and undergoing PEG placement for the first time. The sample size was calculated using the G-Power 3.1 program, resulting in a sample size of 54 (n1=27, n2=27), including the dropout rate. Participants will be randomly assigned to groups. The intervention group will receive hands-on training related to PEG feding and care using a low-fidelity model. In addition, caregivers will be provided with video training on PEG feeding and care that they can watch for review when needed. The control group will receive standard institutional training provided by the nutrition nurse of the institution where the study is conducted. Data will be collected face-to-face using a "Personal Information Form", "State Anxiety Inventory", "Skills Checklist", and "PEG Care Konowledge Form". Three measurements will be taken in the study. Test 0: Before the training (Personal Information Form, State Anxiety Inventory), Test 1: After the training (with the PEG Care Knowledge Form and the State Anxiety Inventory). Additionally, the researcher will evaluate the caregiver's feeding and care practices using the Skills Checklist. Test 2: Two weeks after from the Test 1 (State Anxiety Inventory and PEG Care Konowledge Form), also the researcher will also evaluate the caregiver's practices a second time using the Skills Checklist. Data will be analyzed using the SPSS Statistics 27 software package.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being 18 years of age or older
Being the patient's primary caregiver (the person who regularly provides daily PEG care and nutrition)
Being literate
Being proficient in communicating in Turkish (understanding and expressing oneself)
Disqualifiers
Being under 18 years of age
Being illiterate
Not being proficient in communicating in Turkish
Not giving written informed consent to participate in the study
Trial design
Parallel
Treatments tested in this trial
The PEG feeding and PEG care training enriched with audiovisual materials
Other interventionCaregivers of patients with Percutaneous endoscopic gastrostomy (PEG) tubes will receive hands-on training related to feeding via PEG tube and PEG site care on a low-fidelity model, followed by access to a video for a week. The video will demonstrate skills related to PEG feeding and PEG care. It will help caregivers review aspects they may have forgotten or wish to see again. Given that current hospital PEG feeding and care training is generally oral and short-term, this study, which measures the impact of a "structured and follow-up" training model on stress as well as knowledge and skills, will enrich the scientific knowledge in the literature.
Standard institutional peg feeding and care training provided by the nutrition nurse
Other interventionThis training is provided by nutrition nurses for caregivers in healthcare settings. It is usually a verbal and short demonstration on a patient with a PEG tube inserted. The brevity and verbal nature of the training can lead to caregivers forgetting key points. Furthermore, caregivers may have difficulty contacting a nutrition nurse to refresh their memory and may need to request repeated training from ward nurses.
Treatment groups
Trial outcomes
Primary outcomes
State Anxiety
The State Anxiety Inventory will be used to measure the anxiety levels experienced by caregivers. The scale has 20 items (the answer options are: (1) Never, (2) A little, (3) A lot and (4) Completely), with scores ranging from 20 to 80. Higher scores indicate higher anxiety levels, while lower scores indicate lower anxiety levels.
State anxiety
The State Anxiety Inventory will be used to measure the anxiety levels experienced by caregivers. The scale has 20 items (the answer options are: (1) Never, (2) A little, (3) A lot and (4) Completely), with scores ranging from 20 to 80. Higher scores indicate higher anxiety levels, while lower scores indicate lower anxiety levels.
State anxiety
The State Anxiety Inventory will be used to measure the anxiety levels experienced by caregivers. The scale has 20 items (the answer options are: (1) Never, (2) A little, (3) A lot and (4) Completely), with scores ranging from 20 to 80. Higher scores indicate higher anxiety levels, while lower scores indicate lower anxiety levels.
PEG Care Knowledge
The PEG Care Knowledge Form will be used to measure the knowledge levels acquired by caregivers related to feeding via PEG tube and care for PEG. The form contains 24 statements answered as "True", "False", and "I don't know/I have no opinion". Each correctly answered statement is worth 1 point, while each "I don't know/I have no opinion" or incorrectly answered statement is worth 0 points. The total score on the form ranges from a minimum of 0 to a maximum of 24 points. Higher scores indicate a higher level of knowledge.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: