Having a Percutaneous Endoscopic GastrostomyNCT06712277
The Effect of Video Education on Adaptation to the Procedure of Patients and Caregivers Who Underwent Gastrostomy
A study testing Video training in people with Having a Percutaneous Endoscopic Gastrostomy, run by Melike YAZAR at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted to investigate the effects of video training given to caregivers of patients who underwent percutaneous endoscopic gastrostomy on the compliance of patients and caregivers to gastrostomy. Read more about this study
- Who is it for?
- Ages Up to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Having a Percutaneous Endoscopic Gastrostomy
- What is being tested?
- Video training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 95 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having undergone percutaneous endoscopic gastrostomy for the first time. Not having cancer. -
Who cannot join
- Being over 18 years old, 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to investigate the effects of video training given to caregivers of patients who underwent percutaneous endoscopic gastrostomy on the compliance of patients and caregivers to gastrostomy. A single-group quasi-experimental study was planned 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 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. Statistical Package for the Social Sciences 26 program will be used for statistical analyses 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 in the evaluation of the distribution of the data. Student t test, Oneway Anova test will be used in the evaluation of variables showing normal distribution and Bonferroni test will be used in the determination of the group causing the difference. Paired Samples t test will be used in the evaluations within the groups. Mann Whitney U test, Kruskal Wallis test will be used in the evaluations of variables not showing normal distribution and Dunn test will be used in the determination of the group causing the difference. Wilcoxon Signed Rank test will be used in the evaluations within the groups. Pearson or Spearman's correlation analysis, linear regression modeling will be done in the evaluation of variables. 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 p<0.05.
- Being tested
- Video training
- Keywords
- patients, percutaneous endoscopic gastrostomi, education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video trainingOther
After the procedure, caregivers will be trained on tube care and patient feeding by demonstrating and performing the procedure on an iPad.
| Study group | Role | What they receive |
|---|---|---|
| Patients and caregivers who underwent percutaneous endoscopic gastrostomy for the first time | Experimental | Not described Receives: Other: Video training |
What is being measured
The primary outcome is the main question the study is designed to answer.
caregiver gastrostomy compliance form
It consists of 5 questions that allow the caregiver to express their concerns and troubles while feeding, dressing the tube, giving medication, positioning, and giving body care/bathing to the patient due to the procedure with a value between 0 and 10. The caregiver can get the lowest score from this form: 0, the highest score: 50. A score of 0 from the Caregiver Gastrostomy Adaptation Form indicates that there is no adaptation to gastrostomy, and a score of 50 indicates that there is adaptation to gastrostomy. The form will be finalized after receiving the opinions of 10 experts on the form.
Measured: 1-2 month
Secondary outcomes (1)
Care Skills Assessment Form
It consists of 29 questions measuring care skills, which was created by the researcher in line with the literature in order to evaluate the effectiveness of the training given to the caregivers of the patient with percutaneous endoscopic gastrostomy. The first 27 questions in the care skill evaluation form are worth Yes: 2 points, No: 0 points, Partially: 1 point. 54 points were determined as the highest skill score, 0 points as the lowest skill score. Questions 28 and 29 were created for the evaluation of dressing. The Caregiver Skill Evaluation Form will be filled out by the researcher during the home visit by observing the caregivers on the 14th and 30th day follow-ups. The form will be finalized after receiving the opinions of 10 experts on the form.
Measured: 1-2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start25 Nov 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Having a Percutaneous Endoscopic GastrostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- It was planned as a single-group quasi-experimental study to determine the effect of training on patient and caregiver compliance with gastrostomy and the caregiver's gastrostomy care skills.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melike YAZAR
- Sponsor type
- University, hospital or other
- Collaborators
- Halic University
- Responsible party
- Sponsor-investigator, Melike YAZAR, Beykoz State Hospital
- Investigators
- Melike Yazar, Principal investigator, Beykoz State Hospital Surgical Service Nurse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712277
- Sponsor's protocol ID
- Beykoz State Hospital
- Other IDs
- Higher Education Institution
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collection phase has not been completed yet.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video Education on Adaptation to the Procedure of Patients and Caregivers Who Underwent Gastrostomy
- ClinicalTrials.gov ID
- NCT06712277
- Acronym / sponsor ID
- Beykoz State Hospital
- Keywords
- patients, percutaneous endoscopic gastrostomi, education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Melike YAZARUniversity, hospital or other
- Collaborators
- Halic University
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to investigate the effects of video training given to caregivers of patients who underwent percutaneous endoscopic gastrostomy on the compliance of patients and caregivers to gastrostomy. A single-group quasi-experimental study was planned 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 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. Statistical Package for the Social Sciences 26 program will be used for statistical analyses 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 in the evaluation of the distribution of the data. Student t test, Oneway Anova test will be used in the evaluation of variables showing normal distribution and Bonferroni test will be used in the determination of the group causing the difference. Paired Samples t test will be used in the evaluations within the groups. Mann Whitney U test, Kruskal Wallis test will be used in the evaluations of variables not showing normal distribution and Dunn test will be used in the determination of the group causing the difference. Wilcoxon Signed Rank test will be used in the evaluations within the groups. Pearson or Spearman's correlation analysis, linear regression modeling will be done in the evaluation of variables. 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 p<0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It was planned as a single-group quasi-experimental study to determine the effect of training on patient and caregiver compliance with gastrostomy and the caregiver's gastrostomy care skills.
| Arm | Type | Receives |
|---|---|---|
| Patients and caregivers who underwent percutaneous endoscopic gastrostomy for the first time | Experimental | Other: Video training |
Who may qualify
- Ages
- Up to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Having undergone percutaneous endoscopic gastrostomy for the first time. Not having cancer. -
Key exclusion criteria (3 listed)
- Being over 18 years old, 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video trainingAfter the procedure, caregivers will be trained on tube care and patient feeding by demonstrating and performing the procedure on an iPad. | Other | Patients and caregivers who underwent percutaneous endoscopic gastrostomy for the first time |
Primary outcome
caregiver gastrostomy compliance form
Time frame: 1-2 month
It consists of 5 questions that allow the caregiver to express their concerns and troubles while feeding, dressing the tube, giving medication, positioning, and giving body care/bathing to the patient due to the procedure with a value between 0 and 10. The caregiver can get the lowest score from this form: 0, the highest score: 50. A score of 0 from the Caregiver Gastrostomy Adaptation Form indicates that there is no adaptation to gastrostomy, and a score of 50 indicates that there is adaptation to gastrostomy. The form will be finalized after receiving the opinions of 10 experts on the form.
1 secondary outcome
Care Skills Assessment Form
Time frame: 1-2 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No. The data collection phase has not been completed yet.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melike Yazar principal investigator
Beykoz State Hospital Surgical Service Nurse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video training in people with Having a Percutaneous Endoscopic Gastrostomy, run by Melike YAZAR at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caregiver gastrostomy compliance form (time frame: 1-2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.