- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05272891
Audiobook Application in Patients Receiving Hemodialysis Treatment
The Effect of Audiobook Application on Anxiety, Depression and Quality of Life in Patients Receiving Hemodialysis Treatment
Study Overview
Detailed Description
Hemodialysis is an extracorporeal blood purification technique used to remove accumulated metabolic waste products in patients and is a frequently used treatment method in patients with end-stage renal disease.
Although hemodialysis, which is one of the treatment of end-stage renal disease, prolongs life, it can also lead to various psychological disorders such as depression, anxiety and severe stress. Psychological disorders and depression in dialysis patients often manifest as a response to loss of ability to work and earn an income, decreased energy, decreased sexual function, other limitations caused by physical disability, and reduced life expectancy.
Depression is the most common psychopathological condition in patients with end-stage renal disease. The rate of depressive symptoms among dialysis patients is high and its prevalence is up to 43%, and it is stated that it has a significant effect on quality of life. The psychological and somatic effects of depression can complicate the course of the chronic disease.
Reading books is one of the tools to heal mental disorders. Some individuals cannot read on their own due to aging, poor eyesight, or lack of literacy. An audiobook is a recording of a book read by an author, actor, celebrity, or amateur. Audiobooks are recommended for their friendliness, comfort, and emotional impact. Audiobooks are recommended to increase the quality of life of individuals and to protect social health.
This research will be conducted to evaluate the effects of audio book application on anxiety, depression and quality of life in patients receiving hemodialysis treatment.
Patient information form, hospital anxiety depression scale, SF-36 quality of life scale will be used to collect research data.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Artvin, Turkey, 08100
- Hemodialysis units affiliated to Artvin provincial health directorate
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Over 18 years old,
- Receiving hemodialysis treatment for six months or longer,
- Receiving hemodialysis treatment three times a week,
- No problem with the sense of hearing,
- Has no handicap in answering the questions physically and mentally,
- No verbal communication disability (hearing and speaking),
- Can understand Turkish,
- Not having been diagnosed with a mental illness,
- Patients willing to participate in the study will be recruited
Exclusion Criteria:
- Those who want to withdraw from the research
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
audio book will be played
|
audio book app
Other Names:
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No Intervention: Control Group
No application will be made
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effect of audio book application on anxiety and depression in patients receiving hemodialysis treatment
Time Frame: At the end of 4 weeks
|
Hospital anxiety and depression scale will be used.
The lowest score that patients can get from the scale is 0, and the highest score is 21.
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At the end of 4 weeks
|
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The effect of audio book application on quality of life in patients receiving hemodialysis treatment.
Time Frame: At the end of 4 weeks
|
Short form 36 (SF-36) for quality of life scale will be used.Their scores range from 0-100.
Scores are positively oriented.
Increasing score indicates better quality of life.
|
At the end of 4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sevgi DEMİR ÇAM, Phd Student, Ataturk University
- Study Director: Elanur YILMAZ KARABULUTLU, Prof.Dr., Ataturk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Sevgi Tez
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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