Audiobook Application in Patients Receiving Hemodialysis... | NCT05272891

Studies
Audiobook Application in Patients Receiving Hemodialysis Treatment

NCT05272891

Sponsor

Ataturk University

Status

Completed

Last Update Posted

Nov 22, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Hemodialysis

Interventions

experimental group

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2021Actual

Primary Completion Date

May 25, 2022Actual

Completion Date

Nov 1, 2022Actual

First Submitted Date

Feb 4, 2022

First Submission Date that Met QC Criteria

Mar 8, 2022

First Posted Date

Mar 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2022

Last Update Posted Date

Nov 22, 2022Actual

Name	Class
Artvin Coruh University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	audio book will be played	Other: experimental group
Control Group	No Intervention	No application will be made

Interventions

Name	Type	Description	Arm Group Labels	Other Names
experimental group	Other	audio book app	Experimental	experimental group, audio book app

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The effect of audio book application on anxiety and depression in patients receiving hemodialysis treatment	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.	At the end of 4 weeks
The effect of audio book application on quality of life in patients receiving hemodialysis treatment.	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sevgi DEMİR ÇAM, Phd Student	Ataturk University	Principal Investigator
Elanur YILMAZ KARABULUTLU, Prof.Dr.	Ataturk University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hemodialysis units affiliated to Artvin provincial health directorate		Artvin		08100	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40442032	Derived	Cam SD, Karabulutlu EY. Effects of Listening to an Audiobook on Anxiety, Depression, and Quality of Life in Patients Receiving Hemodialysis: A Randomized Controlled Trial. Hemodial Int. 2025 Oct;29(4):662-671. doi: 10.1111/hdi.13250. Epub 2025 May 29.

ID	Term
D001008	Anxiety Disorders
D003863	Depression

ID	Term
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior