Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:06 AM
Study NCT ID:
NCT05187234
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2021-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Education Hemodialysis Patients According to Roy Adaptation Model
Sponsor:
Kırklareli University
Organization:
Study Overview
Official Title:
The Effect of Education on Fluid Management, Symptom Control and Quality of Life ın Hemodialysis Patients According to Roy Adaptation Model
Status:
COMPLETED
Status Verified Date:
2021-12
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:
None
Brief Summary:
The study was conducted in order to evaluate the effect of the training provided to hemodialysis patients according to Roy Adaptation Model on fluid management, symptom control, and quality of life. The study was carried out as a randomized controlled trial with the participation of 107 patients (53 experimental, 54 control) The patients in the experimental group were provided with training based on Roy Adaptation Model, and training booklets were handed out.The control group did not attempt any intervention.
Detailed Description:
The most difficult domain for hemodialysis patients is fluid-salt restriction. Patients with inadequate fluid compliance/adherence experience many symptoms that negatively affect their life.
The study was carried out as a randomized controlled trial with the participation of 107 patients (53 experimental, 54 control).
The data were collected by using "Patient Information From", "Fluid Control in Hemodialysis Patients Scale" (FCHPS), "Dialysis Symptom Index" (DSI), and "Nottingham Health Profile" (NHP). The forms were filled out by having interviews with the patients in the experimental and control groups in the 0th, 1st, and 3rd months. The patients in the experimental group were provided with training based (face to face individual) on Roy Adaptation Model (0th(onset)and 1st month), and training booklets were handed out. The Training was about 30-45 minutes. control group did not attempt any intervention. Routine maintenance of the control and experimental group and continued. When comparing the experimental and control groups, onset 0th month, 1st month and 3rd month measurements were taken into consideration. All scales were administered to the experimental and control groups at month 0 (onset), 1 and 3 months.
The data were analyzed by using descriptive statistics methods with NCSS (Number Cruncher Statistical System) 2007 software, Student's t-test, Mann-Whitney U Test, Pearson Chi-square test, Fisher-Freeman-Halton Exact test, Repeated Measures test, Bonferroni testi Significance was accepted as p\<0,05.
The study was carried out as a randomized controlled trial with the participation of 107 patients (53 experimental, 54 control).
The data were collected by using "Patient Information From", "Fluid Control in Hemodialysis Patients Scale" (FCHPS), "Dialysis Symptom Index" (DSI), and "Nottingham Health Profile" (NHP). The forms were filled out by having interviews with the patients in the experimental and control groups in the 0th, 1st, and 3rd months. The patients in the experimental group were provided with training based (face to face individual) on Roy Adaptation Model (0th(onset)and 1st month), and training booklets were handed out. The Training was about 30-45 minutes. control group did not attempt any intervention. Routine maintenance of the control and experimental group and continued. When comparing the experimental and control groups, onset 0th month, 1st month and 3rd month measurements were taken into consideration. All scales were administered to the experimental and control groups at month 0 (onset), 1 and 3 months.
The data were analyzed by using descriptive statistics methods with NCSS (Number Cruncher Statistical System) 2007 software, Student's t-test, Mann-Whitney U Test, Pearson Chi-square test, Fisher-Freeman-Halton Exact test, Repeated Measures test, Bonferroni testi Significance was accepted as p\<0,05.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: