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临床试验/NCT05671536
NCT05671536Enrolling By Invitation不适用

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

Baskent University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年4月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
58
试验地点
1
主要终点
Compliance

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Receiving hemodialysis treatment for at least 3 months
  • •18 years old and over
  • •Oriantated
  • •Having no barrier to written or verbal communication
  • •Agreed to participate in the research

排除标准

  • •diagnosed with psychiatric illness
  • •diagnosed with dementia and Alzheimer's

研究组 & 干预措施

Motivational interview

Experimental

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.

干预措施: motivational interview (Behavioral)

Control

No Intervention

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.

结局指标

主要结局

Compliance

时间窗: 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.

Resilience

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Çiğdem Özdemir Eler

Principal Investigator

Baskent University

研究点 (1)

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