Fluid OverloadDialysisSuitNCT07030361
Intradıalytıc Weıght Control In Hemodıalysıs Patıents
A study testing suit group and training group in people with Fluid Overload, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to determine the effect of a dialysis gown designed according to the empowerment model on changes in weight control behaviors among gown group patients during the intradialytic period. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fluid Overload
- What is being tested?
- suit group and training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Feb 2023to 30 Sep 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Turkish-speaking
- Turkish-understanding
- Older than 18 years of age
- Without communication barriers such as visual and hearing impairment
- Non-hypotensive and non-anemic patients
- With an intradialytic weight of 2-5 liters
- Receiving hemodialysis treatment for more than three months and outpatients
Who cannot join
- Patients who had previously received fluid restriction compliance training
- Who refused to participate in the study
- Who had undergone surgery within the last six weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Dialaysis Suit for Hemodialysis Patients Effect of Fluid Restriction on Compliance and Level of Empowerment: Randomise Controlled Trials
The aim of this observational study is to determine the effect of a dialysis gown designed according to the empowerment model on changes in weight control behaviors among gown group patients during the intradialytic period. The main question it seeks to answer is:
- Is the dialysis gown effective in helping gown group patients control their fluid intake during the intradialytic period?
Read the detailed description
In this study, researchers designed a study to compare whether the behavior of controlling excessive fluid intake during the intradialytic period was better in the group of patients wearing dialysis garments designed according to the empowerment model than in the education and control groups. For this randomized controlled study, patients were divided into three groups. The patients were named the garment group, the education group, and the control group. In the study design, patients underwent garment application and education application. In the garment application, the amount of excess fluid removed by ultrafiltration during that dialysis session was placed in the pockets of the serum dialysis garment, and patients were asked to walk in a 10-meter walking test area. In the education application, a video-based education program designed to teach fluid compliance behavior was implemented. Patients were asked to watch this video education program for an average of half an hour at the beginning of each session.
Patients in the garment group were dressed in dialysis garments and shown the educational video. Patients in the education group were only shown the fluid compliance video. No intervention specific to the study was performed on patients in the control group. All patients continued to receive the normal follow-up and care protocol required for hemodialysis treatment.
- Conditions
- Fluid Overload
- Being tested
- suit group, training group, control group
- Keywords
- FluidControl, Compliance, Empowerment, İnnovation, DialysisSuit;
- Medical subject headings
- Edema, Patient Compliance, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suit groupBehavioural
elbise giydirme ve video izletme uygulaması
training groupBehavioural
video izletme uygulaması
control groupBehavioural
rutin hemş bakımı uygulaması, herhangi bir müdahale yok
| Study group | Role | What they receive |
|---|---|---|
| suits group | Active comparator | Dialysis suit group was dressed in dialysis suit and given fluid control training Receives: Behavioral: suit group |
| 2 training group | Placebo comparator | Fluid control training was given to the traininig group Receives: Behavioral: training group |
| control group | Other | Control group received no intervention, clinical care Receives: Behavioral: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
intradialytic fluid balance
weight gained during the intradialytic period
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start22 Feb 2023
- Primary completion5 Jul 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Research data were collected in 3 stages: pretest (Z0), posttest (Z1) and follow-up test (Z2).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Türkan Çalışkan, Balikesir University
- Investigators
- Alper Azak, Asist Prof, Principal investigator, balikesir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030361
- Sponsor's protocol ID
- BalikesirUniversity HealtScien
- Other IDs
- 222S306
- Acronym
- DialysisSuit
- Status last verified
- Jun 2025
- First submitted
- 17 Apr 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the product used in the research has not yet entered the production phaset
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Dialaysis Suit for Hemodialysis Patients Effect of Fluid Restriction on Compliance and Level of Empowerment: Randomise Controlled Trials
- ClinicalTrials.gov ID
- NCT07030361
- Acronym / sponsor ID
- DialysisSuit / BalikesirUniversity HealtScien
- Conditions
- Fluid Overload
- Keywords
- FluidControl, Compliance, Empowerment, İnnovation, DialysisSuit;
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 22 Jun 2025 (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 aim of this observational study is to determine the effect of a dialysis gown designed according to the empowerment model on changes in weight control behaviors among gown group patients during the intradialytic period. The main question it seeks to answer is:
- Is the dialysis gown effective in helping gown group patients control their fluid intake during the intradialytic period?
Detailed description
In this study, researchers designed a study to compare whether the behavior of controlling excessive fluid intake during the intradialytic period was better in the group of patients wearing dialysis garments designed according to the empowerment model than in the education and control groups. For this randomized controlled study, patients were divided into three groups. The patients were named the garment group, the education group, and the control group. In the study design, patients underwent garment application and education application. In the garment application, the amount of excess fluid removed by ultrafiltration during that dialysis session was placed in the pockets of the serum dialysis garment, and patients were asked to walk in a 10-meter walking test area. In the education application, a video-based education program designed to teach fluid compliance behavior was implemented. Patients were asked to watch this video education program for an average of half an hour at the beginning of each session.
Patients in the garment group were dressed in dialysis garments and shown the educational video. Patients in the education group were only shown the fluid compliance video. No intervention specific to the study was performed on patients in the control group. All patients continued to receive the normal follow-up and care protocol required for hemodialysis treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Research data were collected in 3 stages: pretest (Z0), posttest (Z1) and follow-up test (Z2).
| Arm | Type | Receives |
|---|---|---|
| suits group | Active comparator | Behavioral: suit groupDialysis suit group was dressed in dialysis suit and given fluid control training |
| 2 training group | Placebo comparator | Behavioral: training groupFluid control training was given to the traininig group |
| control group | Other | Behavioral: control groupControl group received no intervention, clinical care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Turkish-speaking
- Turkish-understanding
- Older than 18 years of age
- Without communication barriers such as visual and hearing impairment
- Non-hypotensive and non-anemic patients
Key exclusion criteria (3 listed)
- Patients who had previously received fluid restriction compliance training
- Who refused to participate in the study
- Who had undergone surgery within the last six weeks
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 |
|---|---|---|
| suit groupelbise giydirme ve video izletme uygulaması | Behavioural | suits group |
| training groupvideo izletme uygulaması | Behavioural | 2 training group |
| control grouprutin hemş bakımı uygulaması, herhangi bir müdahale yok | Behavioural | control group |
Primary outcome
intradialytic fluid balance
Time frame: 8 weeks
weight gained during the intradialytic period
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 22 Jun 2025.
- national thesis centerLink provided by the sponsor.
- Individual participant dataSharing planned: No. the product used in the research has not yet entered the production phaset
Related trials for Fluid Overload
Recruiting
Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
Acute Kidney Injury, Fluid Overload
Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Chronic Heart Failure, CKD Stage 3
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
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.
Alper Azak, Asist Prof principal investigator
balikesir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suit group and training group in people with Fluid Overload, run by Balikesir University 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 7 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 22 Jun 2025. 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. Some participants in this study may receive a placebo. 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?
intradialytic fluid balance (time frame: 8 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 22 Jun 2025.