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Caregiver Training Regarding Percutaneous Endoscopic Gastrostomy Feeding and Care

9 giugno 2026 aggiornato da: Nagihan Ilaslan, Duzce University

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

54

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
State Anxiety
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

30 dicembre 2026

Completamento dello studio (Stimato)

30 marzo 2027

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 giugno 2026

Primo Inserito (Effettivo)

15 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Ilaslan-002

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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