Difficulty SwallowingNCP-PEGNCT07436442
THE IMPACT OF NURSİNG CARE ON COMPLİCATİON İN PEG PATİENTS
A study testing customized training in people with Difficulty Swallowing, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to investigate the impact of nursing care on complications in patients undergoing percutaneous endoscopic gastrostomy (PEG) placement. For the implementation of this randomized controlled study, approval (No: E-46418926-050.99-132774) was obtained from the Ethics Committee of a university on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficulty Swallowing
- What is being tested?
- customized training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2022to 16 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agreeing to participate in the study,
- Being over 18 years of age,
- Having sound cognitive abilities,
- Being able to communicate in Turkish,
- Being literate,
- The caregiver not having any communication impediments.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan 2. Abdulhamid Han Eah
Istanbul, Istanbul, 34668
About this study
Official title: THE EFFECT OF NURSING CARE ON COMPLICATIONS IN PATIENTS UNDERGOING PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT
This study was conducted to investigate the impact of nursing care on complications in patients undergoing percutaneous endoscopic gastrostomy (PEG) placement.
For the implementation of this randomized controlled study, approval (No: E-46418926-050.99-132774) was obtained from the Ethics Committee of a university on the Anatolian side of Istanbul. The study population comprised all patients who underwent percutaneous endoscopic gastrostomy in the endoscopy unit of the same university hospital between January 3, 2022, and December 16, 2022, while the sample included 60 patients who met the inclusion criteria between April 1, 2022, and December 16, 2022. Data were collected using the Sociodemographic Data Form, Caregiver Information Form, Pre-Procedural Preparation-Before-During Monitoring and Follow-Up Data Form, Post-Percutaneous Endoscopic Gastrostomy Vital Signs, Stoma and Tube Follow-Up Form, and Post-Discharge Home Care Evaluation Form. For statistical analysis of the data obtained from the study, IBM SPSS V22 software was used. The normality of distribution was assessed using the Shapiro-Wilk test. An Independent Samples t-test was applied for comparing normally distributed variables between groups, while the Mann-Whitney U Test was used for non-normally distributed variables. For categorical variables, Yates' Correction, Fisher's Exact Test, and Pearson's Chi-Square Test were used; multiple comparisons were performed using the Bonferroni-corrected Z-test. The analysis results were presented as mean ± standard deviation and median (minimum-maximum) for quantitative variables, and as frequency (percentage) for categorical variables. The level of significance was set at p<0.050.
Keywords: Oral care, Training, Nursing, Complications, Percutaneous endoscopic gastrostomy.
- Conditions
- Difficulty Swallowing
- Being tested
- customized training
- Keywords
- COMPLİCATİON
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
customized trainingOther
Also called oral care, special education
Patients in the intervention group received "Specialized Training" from the researcher on the management of percutaneous endoscopic gastrostomy.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Endoscopic Gastrostomy Intervention Group | Experimental | Patients in the intervention group received customized training from the researcher. Receives: Other: customized training |
| Percutaneous Endoscopic Gastrostomy Control Group | No intervention | The group that was not interfered with by the researcher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of nursing care on complications in patients undergoing percutaneous endoscopic gastrostomy placement
Patients in the intervention group who received special education were compared with patients in the control group who did not receive special education in terms of complication rates.
Measured: Patients were monitored during the procedure: 30 minutes, post-PEG: 60 minutes, first dressing change and education: 45 minutes. Evaluation four weeks after discharge: 20 minutes. Data were evaluated after the completion of the study (9 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start3 Apr 2022
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficulty SwallowingStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- According to the research design and sample size calculation, patients who agreed to participate in the study under the same environment and conditions and who met all the inclusion criteria were divided into two groups, intervention and control groups, to determine the effect of the dependent variable. Randomization was performed by assigning a sequence number starting with the nearest endoscopy appointment date. In randomization, each patient participating in the study was given a sequence number from 1, 2, 3, ... to 60. The sequence number assigned to the patient was compared with the numbers in the randomization group list. The patient was assigned to the group whose sequence number matched the number in the randomization list. The random.org program was used for randomization.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgül TORUN, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436442
- Sponsor's protocol ID
- Sultan 2. Abdulhamid Han EAH
- Acronym
- NCP-PEG
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF NURSING CARE ON COMPLICATIONS IN PATIENTS UNDERGOING PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT
- ClinicalTrials.gov ID
- NCT07436442
- Acronym / sponsor ID
- NCP-PEG / Sultan 2. Abdulhamid Han EAH
- Conditions
- Difficulty Swallowing
- Keywords
- COMPLİCATİON
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 3 Apr 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 27 Feb 2026 (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 was conducted to investigate the impact of nursing care on complications in patients undergoing percutaneous endoscopic gastrostomy (PEG) placement.
For the implementation of this randomized controlled study, approval (No: E-46418926-050.99-132774) was obtained from the Ethics Committee of a university on the Anatolian side of Istanbul. The study population comprised all patients who underwent percutaneous endoscopic gastrostomy in the endoscopy unit of the same university hospital between January 3, 2022, and December 16, 2022, while the sample included 60 patients who met the inclusion criteria between April 1, 2022, and December 16, 2022. Data were collected using the Sociodemographic Data Form, Caregiver Information Form, Pre-Procedural Preparation-Before-During Monitoring and Follow-Up Data Form, Post-Percutaneous Endoscopic Gastrostomy Vital Signs, Stoma and Tube Follow-Up Form, and Post-Discharge Home Care Evaluation Form. For statistical analysis of the data obtained from the study, IBM SPSS V22 software was used. The normality of distribution was assessed using the Shapiro-Wilk test. An Independent Samples t-test was applied for comparing normally distributed variables between groups, while the Mann-Whitney U Test was used for non-normally distributed variables. For categorical variables, Yates' Correction, Fisher's Exact Test, and Pearson's Chi-Square Test were used; multiple comparisons were performed using the Bonferroni-corrected Z-test. The analysis results were presented as mean ± standard deviation and median (minimum-maximum) for quantitative variables, and as frequency (percentage) for categorical variables. The level of significance was set at p<0.050.
Keywords: Oral care, Training, Nursing, Complications, Percutaneous endoscopic gastrostomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- According to the research design and sample size calculation, patients who agreed to participate in the study under the same environment and conditions and who met all the inclusion criteria were divided into two groups, intervention and control groups, to determine the effect of the dependent variable. Randomization was performed by assigning a sequence number starting with the nearest endoscopy appointment date. In randomization, each patient participating in the study was given a sequence number from 1, 2, 3, ... to 60. The sequence number assigned to the patient was compared with the numbers in the randomization group list. The patient was assigned to the group whose sequence number matched the number in the randomization list. The random.org program was used for randomization.
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Endoscopic Gastrostomy Intervention Group | Experimental | Other: customized trainingPatients in the intervention group received customized training from the researcher. |
| Percutaneous Endoscopic Gastrostomy Control Group | No intervention | –The group that was not interfered with by the researcher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Agreeing to participate in the study,
- Being over 18 years of age,
- Having sound cognitive abilities,
- Being able to communicate in Turkish,
- Being literate,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| customized trainingAlso: oral care, special educationPatients in the intervention group received "Specialized Training" from the researcher on the management of percutaneous endoscopic gastrostomy. | Other | Percutaneous Endoscopic Gastrostomy Intervention Group |
Primary outcome
The effect of nursing care on complications in patients undergoing percutaneous endoscopic gastrostomy placement
Time frame: Patients were monitored during the procedure: 30 minutes, post-PEG: 60 minutes, first dressing change and education: 45 minutes. Evaluation four weeks after discharge: 20 minutes. Data were evaluated after the completion of the study (9 months).
Patients in the intervention group who received special education were compared with patients in the control group who did not receive special education in terms of complication rates.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing customized training in people with Difficulty Swallowing, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 6 inclusion and 0 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: finished, as of the sponsor's last update on 27 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The effect of nursing care on complications in patients undergoing percutaneous endoscopic gastrostomy placement (time frame: Patients were monitored during the procedure: 30 minutes, post-PEG: 60 minutes, first dressing change and education: 45 minutes. Evaluation four weeks after discharge: 20 minutes. Data were evaluated after the completion of the study (9 months).). 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 27 Feb 2026.