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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05671536
Other study ID # KA21/55
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 26, 2022
Est. completion date March 25, 2023

Study information

Verified date January 2023
Source Baskent University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research consists of two stages: the first stage aims to evaluate the validity and reliability of the Hemodialysis Resilience Scale, which was developed to evaluate the resilience of patients receiving hemodialysis treatment, in Turkish society, and the second stage aims to determine the effect of motivational interviewing method on patients' psychological resilience and compliance with hemodialysis treatment in individuals undergoing hemodialysis. The main question it aims to answer is: Does motivational interviewing has an effect on psychological resilience and treatment compliance of hemodialysis patients?


Description:

The aims of this study are to evaluate the validity and reliability of the Hemodialysis Resilience Scale, which was developed to evaluate the resilience of patients receiving hemodialysis treatment, in Turkish society, and to determine the effect of motivational interviewing method on patients' psychological resilience and compliance with hemodialysis treatment in individuals undergoing hemodialysis. This research consists of two stages: the first stage is a methodological study for scale adaptation, and second stage is randomized, controlled, and single blinded study for determining the effect of motivational interviewing. The first stage is carried out in patients undergoing hemodialysis in two different hospitals. The second stage of the study consists of a randomized, controlled, and single-blinded experimental study to determine the effect of motivational interviewing on individuals undergoing hemodialysis treatment, in terms of psychological resilience and compliance with treatment. The "simple randomization method" was chosenfor allocation in order to provide an equal number of samples in the two groups. In order to reduce the selection bias in determining intervention and control groups, a list was created by a third party (dialysis center nurse) who did not have a direct role in the study, and assignments were performed using the random numbers table. The intervention and control group patients were scheduled to have hemodialysis sessions on different days. In the study, blinding was applied only to the patient groups because the groups were known by the researchers and nurses.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 58
Est. completion date March 25, 2023
Est. primary completion date January 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Receiving hemodialysis treatment for at least 3 months - 18 years old and over - Oriantated - literate - Having no barrier to written or verbal communication - Agreed to participate in the research Exclusion Criteria: - diagnosed with psychiatric illness - diagnosed with dementia and Alzheimer's

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
motivational interview
Intervention arm will receive motivational interview by the researcher, once a month for 4 times at least 20 minutes. The researcher received education about motivational interview.

Locations

Country Name City State
Turkey Baskent University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resilience Patient on Hemodialysis Resilience Scale is a valid and 5-point Likert type scale with minimum 0 and maximum 80 points. Higher score means higher resilience. Change=Higher score from Patient on Hemodialysis Resilience Scale at 5 months compared to baseline. Baseline and 5 months.
Primary Compliance End Stage Renal Failure Compliance Scale is a valid and 5-point Likert type scale with minimum 0 and maximum 1200 points. Higher score means higher compliance. Change= Higher score from End Stage Renal Failure Compliance Scale at 5 months compared to baseline. Baseline and 5 months.
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