EducationNCT06546852
The Effect of Fluid Training Given to Hemodialysis Patients on Interdialytic Fluid Intake and Blood Pressure
A study testing education in people with Education and Nursing Caries, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
The research evaluated the effect of nutrition and fluid restriction training on interdialytic fluid intake and intradialytic hypotension in hemodialysis patients. The study sample, conducted with an experimental design, consisted of 71 patients (36 experimental and 35 control) who received dialysis treatment in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Education, Nursing Caries
- What is being tested?
- education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 28 Apr 2023
- 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
- Above 18 years old
- volunteering
- good communication
- chronic kidney failure
- no amputation
- hemodialysis 3 days a week
Who cannot join
- Heart battery
- dialysis 2 days a week
- more than 200ml of urine
Trial locations and contacts
1 site in 1 country.
About this study
The research evaluated the effect of nutrition and fluid restriction training on interdialytic fluid intake and intradialytic hypotension in hemodialysis patients. The study sample, conducted with an experimental design, consisted of 71 patients (36 experimental and 35 control) who received dialysis treatment in a private dialysis centre affiliated with the Istanbul Provincial Health Directorate.
Read the detailed description
The research evaluated the effect of nutrition and fluid restriction training on interdialytic fluid intake and intradialytic hypotension in hemodialysis patients. The study sample, conducted with an experimental design, consisted of 71 patients (36 experimental and 35 control) who received dialysis treatment in a private dialysis centre affiliated with the Istanbul Provincial Health Directorate. Fluid Control Scale in Hemodialysis Patients (HHSÖ), Blood Pressure Control Form, Bioimpedance Analysis, Bioimpedance Analysis Compliance Form, Things to Consider Before Bioimpedance Analysis, and Nutrition Booklet for Dialysis Patients were used to collect the data. Parametric methods were used to analyze the data. Differences between the proportions of categorical variables in independent groups were analyzed with Chi-Square and Fisher's exact tests. The t-test was used to compare quantitative continuous data between two independent groups. A dependent group t-test was used to compare intra-group measurements.
After randomization of the experimental and control groups, both groups were measured with the BCM (Fresenius Medical Care Body Composition Monitor) device. The experimental group was given face-to-face fluid restriction training in line with the Nutrition Booklet for Dialysis Patients. At the end of the second month, BCM was measured again in both groups. During the follow-up of the experimental group, training was repeated according to the needs of the patients.
- Conditions
- Education, Nursing Caries
- Being tested
- education
- Keywords
- education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationBehavioural
Also called Patient education will be provide
Patient education will be provide
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group will be informed about the purpose and method of the research and will be informed in writing.
Informed consent was obtained. Patient Tracking Form, which is a data collection tool, The researcher filled out the Fluid Restriction Scale in Hemodialysis Patients through face-to-face interviews with the patients.
The results of the biochemical parameters requested by the physician were recorded. Later Patients will be given a 15-20 minute individual session on fluid restriction in chronic renal failure.
A training and education booklet was provided. At the end of the training, the Fluid Restriction Scale in Hemodialysis Patients was applied to the experimental group as a posttest. Receives: Behavioral: education |
| Control group | No intervention | As for the control group, Information was given about the purpose and method of the research, and a written Informed consent was obtained. Data collection tools: Patient Follow-up Form, Hemodialysis patients fluid restriction scale The researcher completed it during face-to-face interviews with the patients. At the end of the follow-up period, the hemodialysis patients completed the fluid restriction scale as a final test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complying with fluid restriction
Thanks to the training given, patients consume less fluid. posttests were performed usingthe fluid control scale on Hemdodialysis patients.
The lowest score from the scale is 24 and the highest score is 72. from scale As the score increases, patients' compliance with fluid control also increases.
Measured: 14 weeks,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jan 2023
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study sample, conducted with an experimental design, consisted of 71 patients (36 experimental and 35 control) who received dialysis treatment in a private dialysis centre affiliated with the Istanbul Provincial Health Directorate.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü YILMAZ, University of Beykent
- Investigators
- ülkü yılmaz, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546852
- Sponsor's protocol ID
- 29 temmuz
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fluid Training Given to Hemodialysis Patients on Interdialytic Fluid Intake and Blood Pressure
- ClinicalTrials.gov ID
- NCT06546852
- Acronym / sponsor ID
- 29 temmuz
- Conditions
- Education, Nursing Caries
- Keywords
- education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 9 Aug 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.
The research evaluated the effect of nutrition and fluid restriction training on interdialytic fluid intake and intradialytic hypotension in hemodialysis patients. The study sample, conducted with an experimental design, consisted of 71 patients (36 experimental and 35 control) who received dialysis treatment in a private dialysis centre affiliated with the Istanbul Provincial Health Directorate.
Detailed description
The research evaluated the effect of nutrition and fluid restriction training on interdialytic fluid intake and intradialytic hypotension in hemodialysis patients. The study sample, conducted with an experimental design, consisted of 71 patients (36 experimental and 35 control) who received dialysis treatment in a private dialysis centre affiliated with the Istanbul Provincial Health Directorate. Fluid Control Scale in Hemodialysis Patients (HHSÖ), Blood Pressure Control Form, Bioimpedance Analysis, Bioimpedance Analysis Compliance Form, Things to Consider Before Bioimpedance Analysis, and Nutrition Booklet for Dialysis Patients were used to collect the data. Parametric methods were used to analyze the data. Differences between the proportions of categorical variables in independent groups were analyzed with Chi-Square and Fisher's exact tests. The t-test was used to compare quantitative continuous data between two independent groups. A dependent group t-test was used to compare intra-group measurements.
After randomization of the experimental and control groups, both groups were measured with the BCM (Fresenius Medical Care Body Composition Monitor) device. The experimental group was given face-to-face fluid restriction training in line with the Nutrition Booklet for Dialysis Patients. At the end of the second month, BCM was measured again in both groups. During the follow-up of the experimental group, training was repeated according to the needs of the patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study sample, conducted with an experimental design, consisted of 71 patients (36 experimental and 35 control) who received dialysis treatment in a private dialysis centre affiliated with the Istanbul Provincial Health Directorate.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: educationThe experimental group will be informed about the purpose and method of the research and will be informed in writing. Informed consent was obtained. Patient Tracking Form, which is a data collection tool, The researcher filled out the Fluid Restriction Scale in Hemodialysis Patients through face-to-face interviews with the patients. The results of the biochemical parameters requested by the physician were recorded. Later Patients will be given a 15-20 minute individual session on fluid restriction in chronic renal failure. A training and education booklet was provided. At the end of the training, the Fluid Restriction Scale in Hemodialysis Patients was applied to the experimental group as a posttest. |
| Control group | No intervention | –As for the control group, Information was given about the purpose and method of the research, and a written Informed consent was obtained. Data collection tools: Patient Follow-up Form, Hemodialysis patients fluid restriction scale The researcher completed it during face-to-face interviews with the patients. At the end of the follow-up period, the hemodialysis patients completed the fluid restriction scale as a final test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Above 18 years old
- volunteering
- good communication
- chronic kidney failure
- no amputation
Key exclusion criteria (3 listed)
- Heart battery
- dialysis 2 days a week
- more than 200ml of urine
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 |
|---|---|---|
| educationAlso: Patient education will be providePatient education will be provide | Behavioural | Experimental group |
Primary outcome
Complying with fluid restriction
Time frame: 14 weeks,
Thanks to the training given, patients consume less fluid. posttests were performed usingthe fluid control scale on Hemdodialysis patients. The lowest score from the scale is 24 and the highest score is 72. from scale As the score increases, patients' compliance with fluid control also increases.
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 9 Aug 2024.
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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.
ülkü yılmaz principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Education and Nursing Caries, run by University of Beykent 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 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: finished, as of the sponsor's last update on 9 Aug 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?
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?
Complying with fluid restriction (time frame: 14 weeks,). 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 9 Aug 2024.