Caregiver Training Regarding Percutaneous Endoscopic Gastrostomy Feeding and Care

NCT07647185 | Not Yet Recruiting

• 1 other identifier: Ilaslan-002
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Caregiver; Caregiver Anxiety; Simulation Training; State Anxiety; Nursing Care; Video-Assisted; Percutaneous Endoscopic Gastrostomy (PEG); Training

Keywords

Nursing; Caregivers; Simulation Training; Anxiety; Gastrostomy

Outcome Measures

Primary Outcomes (8)

• 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.

  At enrollment (baseline)

• 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.

  Immediately after one week of training

• 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.

  Two weeks after the measurement taken following the training

• 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.

  Immediately after one week of training

• 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.

  Two weeks after the measurement taken following the training

• Peg feeding and care skill

  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

  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

  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

Study Arms (2)

The PEG feeding and PEG care training enriched with audiovisual materials

EXPERIMENTAL

This group that will receive the hands-on PEG feeding and PEG care training, enriched with audiovisual materials (video)

Other: The PEG feeding and PEG care training enriched with audiovisual materials

The standard institutional training based on verbal expression

ACTIVE COMPARATOR

This group that will receive the standard institutional training provided by the nutrition nurse of the institution where the study is conducted

Other: Standard institutional peg feeding and care training provided by the nutrition nurse

Interventions

The PEG feeding and PEG care training enriched with audiovisual materials OTHER

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.

The PEG feeding and PEG care training enriched with audiovisual materials

Standard institutional peg feeding and care training provided by the nutrition nurse OTHER

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.

The standard institutional training based on verbal expression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duzce University: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Nagihan İLASLAN, PhD

CONTACT

+903805421141; nagihan-bitik@windowslive.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share