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CompletedNCT06546852Updated Aug 9, 2024

The Effect of Fluid Training Given to Hemodialysis Patients on Interdialytic Fluid Intake and Blood Pressure

An interventional study of education in Education and Nursing Caries, sponsored by University of Beykent. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by University of Beykent · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jan 2023, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Education
  • Nursing Caries

Keywords

  • education
03

In context

Lead sponsor

University of Beykent is the lead sponsor of 54 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Above 18 years old
  • volunteering
  • good communication
  • chronic kidney failure
  • no amputation
  • hemodialysis 3 days a week

Exclusion criteria

Exclusion Criteria:

  • Heart battery
  • dialysis 2 days a week
  • more than 200ml of urine
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    Experimental group

    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.

    Behavioral: education

  • No intervention
    Control group

    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.

Interventions

  • Behavioraleducation

    Patient education will be provide

    Also known as: Patient education will be provide

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 14 weeks,

07

Study locations

1 site
  • Ülkü Yılmaz
    Istanbul, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06546852
Lead sponsor
University of Beykent
Responsible party
Ülkü YILMAZ (phd internal diseases nurse, University of Beykent) — Principal investigator
First posted
Aug 9, 2024
Start date
Jan 1, 2023
Primary completion
Apr 28, 2023
Completion
Apr 28, 2023
Last update
Aug 9, 2024

Study contacts

ülkü yılmaz
principal investigator · Istanbul University - Cerrahpasa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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