Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:21 PM
Study NCT ID:
NCT07030361
Status:
COMPLETED
Last Update Posted:
2025-06-22
First Post:
2025-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intradıalytıc Weıght Control In Hemodıalysıs Patıents
Sponsor:
Balikesir University
Organization:
Study Overview
Official Title:
Innovative Dialaysis Suit for Hemodialysis Patients Effect of Fluid Restriction on Compliance and Level of Empowerment: Randomise Controlled Trials
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DialysisSuit
Brief 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. 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?
• 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 222S306 | OTHER_GRANT | TÜBİTAK | View |