Intradıalytıc Weıght Control In Hemodıalysıs Patıents
DialysisSuit
Innovative Dialaysis Suit for Hemodialysis Patients Effect of Fluid Restriction on Compliance and Level of Empowerment: Randomise Controlled Trials
2 other identifiers
interventional
66
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedFirst Submitted
Initial submission to the registry
April 17, 2025
CompletedFirst Posted
Study publicly available on registry
June 22, 2025
CompletedJune 22, 2025
June 1, 2025
4 months
April 17, 2025
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
intradialytic fluid balance
weight gained during the intradialytic period
8 weeks
Study Arms (3)
suits group
ACTIVE COMPARATORDialysis suit group was dressed in dialysis suit and given fluid control training
2 training group
PLACEBO COMPARATORFluid control training was given to the traininig group
control group
OTHERControl group received no intervention, clinical care
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Balikesir University
Balıkesir, 10145, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alper Azak, Asist Prof
balikesir
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- asist proff
Study Record Dates
First Submitted
April 17, 2025
First Posted
June 22, 2025
Study Start
February 22, 2023
Primary Completion
July 5, 2023
Study Completion
September 30, 2023
Last Updated
June 22, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share
the product used in the research has not yet entered the production phaset