- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07647185
Caregiver Training Regarding Percutaneous Endoscopic Gastrostomy Feeding and Care
Effects of Caregiver Training on Stress, Knowledge, and Skill Level Regarding Percutaneous Endoscopic Gastrostomy Care
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.
Study Overview
Status
Conditions
Detailed Description
Background: During PEG insertion, the tube is placed directly into the stomach through the abdominal wall. In this context, healthcare professionals explain to caregivers who will support the patient after discharge how to use the PEG, how to change the dressing, and how to administer nutrients. PEG care and feeding, which are performed with nurses in the hospital setting, are the responsibility of the caregiver after discharge. Therefore, caregivers face challenges such as physical and mental fatigue, social isolation, health problems, economic difficulties, deterioration of family relationships, and difficulties in providing physical care. They often struggle and fall short in areas such as providing needs-based care, understanding important considerations during caregiving, identifying urgent patient situations, and managing patient nutrition.In this regard, consistent guidance and health education for caregivers are needed regarding the use of the tube, the recognition and management of complications by caregivers, and skin care.
In this context, the training needed by caregivers of PEG patients can be provided based on Kolb's Theory of Experiential Learning, sequentially following these steps: concrete experience, reflective observation, abstract conceptualization, and active experiential learning. In this research, the PEG care training to be offered to caregivers will be structured based on the principles of experiential learning. During the training process, concrete experience will be created through demonstration and practical training on a model, reflective observation will be supported by feedback and discussion, abstract conceptualization will be achieved through the transfer of theoretical knowledge, and active experiential learning will be realized through repeated applications. It is predicted that this structured process will result in changes in caregivers' knowledge level, application skills, and stress levels related to PEG care.
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.
Methods: The study population will consist of caregivers of patients receiving inpatient care at a state hospital and undergoing PEG placement for the first time. According to the hospital's data, a total of 100 patients underwent PEG placement at the hospital between January and December 2025. 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. (Inclusion criteria: Being 18 years of age or older, Being the patient's primary caregiver (the person who regularly provides daily PEG care and feeding), Being literate, Being proficient in communicating in Turkish (understanding and expressing oneself), Volunteering to participate in the study and providing written informed consent, The caregiver must not have a diagnosed and currently active psychiatric illness requiring treatment.) Caregivers will first be informed about the purpose and scope of the study; participants who agree to participate will be asked to provide written informed consent through an informed consent form. The intervention group will receive hands-on training on the components of a PEG tube, placement of the feeding syringe, administration of feeding formula, and how to draw formula into the syringe, using a low-fidelity model brought to the hospital setting by the researcher. Caregivers will practice these techniques one-on-one on the model. In addition, caregivers will be provided with video training on PEG feeding and care that they can watch for review when needed. The video will be filmed on the model using real materials and professionally edited (with added informational content such as product descriptions and critical theoretical information). 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 (To gather participants' descriptive characteristics, a 15-item form will be used, asking caregivers about their age, gender, marital status, income level, prior knowledge of PEG training, family type, and any existing illnesses. No points are awarded for the form; the data is presented in categorized form)", "State Anxiety Inventory (It 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.)", "Skills Checklist (The Skills Checklist is used to assess the PEG feeding and care skills of caregivers who have received PEG training.The 27-item checklist, which allows researchers to evaluate the caregiver's skills as follows: Completed (2 points) if the caregiver performed the step, Partially completed (1 point) if they did not complete it on time or with assistance, and Not completed (0 points) if they did not complete it, will be used by the researcher while observing the caregiver's skills. The total score will be calculated by summing the point values assigned to each step. A high score will indicate high proficiency in PEG feeding and care.)", and "PEG Care Knowledge Form (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.)". Three measurements will be taken in the study. Test 0: Before the training, both the experimental and control groups will be administered the Personal Information Form and the State Anxiety Inventory. Test 1: After the training (the intervention group will receive training within the scope of the study, the control group will receive standard institutional training), caregivers will be asked to complete 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, the State Anxiety Inventory and the PEG Care Knowledge Form will be administered again. 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nagihan İLASLAN, PhD
- Phone Number: +903805421141
- Email: nagihan-bitik@windowslive.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
- Volunteering to participate in the study and providing written informed consent
- The caregiver must not have a diagnosed psychiatric illness requiring active treatment
Exclusion Criteria:
- 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
- Having a diagnosed psychiatric illness requiring active treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The PEG feeding and PEG care training enriched with audiovisual materials
This group that will receive the hands-on PEG feeding and PEG care training, enriched with audiovisual materials (video)
|
Caregivers 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.
|
|
Active Comparator: The standard institutional training based on verbal expression
This group that will receive the standard institutional training provided by the nutrition nurse of the institution where the study is conducted
|
This 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety
Time Frame: At enrollment (baseline)
|
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.
|
At enrollment (baseline)
|
|
State anxiety
Time Frame: Immediately after one week of training
|
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.
|
Immediately after one week of training
|
|
State anxiety
Time Frame: Two weeks after the measurement taken following the training
|
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.
|
Two weeks after the measurement taken following the training
|
|
PEG Care Knowledge
Time Frame: Immediately after one week of training
|
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.
|
Immediately after one week of training
|
|
PEG Care Knowledge
Time Frame: Two weeks after the measurement taken following the training
|
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.
|
Two weeks after the measurement taken following the training
|
|
Peg feeding and care skill
Time Frame: Immediately after one week of training
|
The Skills Checklist is used to assess the PEG feeding and care skills of caregivers who have received PEG training.The 27-item checklist, which allows researchers to evaluate the caregiver's skills as follows: Completed (2 points) if the caregiver performed the step, Partially completed (1 point) if they did not complete it on time or with assistance, and Not completed (0 points) if they did not complete it, will be used by the researcher while observing the caregiver's skills.
The total score will be calculated by summing the point values assigned to each step.
A high score will indicate high proficiency in PEG feeding and care.
|
Immediately after one week of training
|
|
Peg feeding and care skill
Time Frame: Two weeks after the measurement taken following the training
|
The Skills Checklist is used to assess the PEG feeding and care skills of caregivers who have received PEG training.The 27-item checklist, which allows researchers to evaluate the caregiver's skills as follows: Completed (2 points) if the caregiver performed the step, Partially completed (1 point) if they did not complete it on time or with assistance, and Not completed (0 points) if they did not complete it, will be used by the researcher while observing the caregiver's skills.
The total score will be calculated by summing the point values assigned to each step.
A high score will indicate high proficiency in PEG feeding and care.
|
Two weeks after the measurement taken following the training
|
|
Personal Information
Time Frame: At enrollment
|
To gather participants' descriptive characteristics, a 15-item form will be used, asking caregivers about their age, gender, marital status, income level, prior knowledge of PEG training, family type, and any existing illnesses.
No points are awarded for the form; the data is presented in categorized form.
|
At enrollment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ilaslan-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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