The Effect of Motivational Interview on Hemodialysis Patients

Sponsor

Baskent University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05671536

Collaborator

(none)

Enrollment

Location

Arms

10.9

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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?

Condition or Disease	Intervention/Treatment	Phase
Hemodialysis	Behavioral: motivational interview	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients, undergoing hemodialysis treatment will be assigned to either intervention or control group via simple randomization. Patients on control group will receive standard care. Patients on intervention group will receive 4 sessions of motivational interview at least 20 minutes and once a month. Resilience of all groups will be evaluated at the beginnig of the study and five months after the beginning of the study.Patients, undergoing hemodialysis treatment will be assigned to either intervention or control group via simple randomization. Patients on control group will receive standard care. Patients on intervention group will receive 4 sessions of motivational interview at least 20 minutes and once a month. Resilience of all groups will be evaluated at the beginnig of the study and five months after the beginning of the study.

Masking:

Single (Participant)

Masking Description:

In order to reduce the selection bias in the determination of 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 intervention and control group assignments were made using the randomization method from the random numbers table. The intervention and control group patients were scheduled to have hemodialysis sessions on different days.

Primary Purpose:

Supportive Care

Official Title:

The Effect of Motivational Interviewing Method on Psychological Stability and Treatment Compliance In Hemodialysis Patients

Actual Study Start Date :

Apr 26, 2022

Anticipated Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

Mar 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Motivational interview Patients on intervention group will receive 4 sessions of motivational interview at least 20 minutes and once a month. Resilience of patients will be evaluated at the beginnig of the study and five months after the beginning of the study.	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.
No Intervention: Control Patients on control group will receive standard care. Resilience of patients will be evaluated at the beginnig of the study and five months after the beginning of the study.

Arm

Intervention/Treatment

Experimental: Motivational interview

Patients on intervention group will receive 4 sessions of motivational interview at least 20 minutes and once a month. Resilience of patients will be evaluated at the beginnig of the study and five months after the beginning of the study.

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.

No Intervention: Control

Patients on control group will receive standard care. Resilience of patients will be evaluated at the beginnig of the study and five months after the beginning of the study.

Outcome Measures

Primary Outcome Measures

Resilience [Baseline and 5 months.]
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.
Compliance [Baseline and 5 months.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baskent University	Ankara		Turkey	06490

Sponsors and Collaborators

Baskent University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Çiğdem Özdemir Eler, Principal Investigator, Baskent University

ClinicalTrials.gov Identifier:

NCT05671536

Other Study ID Numbers:

KA21/55

First Posted:

Jan 4, 2023

Last Update Posted:

Jan 4, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Çiğdem Özdemir Eler, Principal Investigator, Baskent University

Patient on hemodialysis

resilience

nursing

motivational interview

Study Results

No Results Posted as of Jan 4, 2023