HemodialysisNCT05272891
Audiobook Application in Patients Receiving Hemodialysis Treatment
A study testing experimental group in people with Hemodialysis, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
Show all 9Show fewer
- Can understand Turkish,
- Not having been diagnosed with a mental illness,
- Patients willing to participate in the study will be recruited
Who cannot join
- Those who want to withdraw from the research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hemodialysis units affiliated to Artvin provincial health directorate
Artvin, 08100
About this study
Official title: The Effect of Audiobook Application on Anxiety, Depression and Quality of Life in Patients Receiving Hemodialysis Treatment
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.
Read the 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.
- Conditions
- Hemodialysis
- Being tested
- experimental group
- Keywords
- Anxiety, Depression, Quality of Life, nurse, Audio book
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupOther
Also called experimental group, audio book app
audio book app
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | audio book will be played Receives: Other: experimental group |
| Control Group | No intervention | No application will be made |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the end of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start20 Apr 2021
- Primary completion25 May 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After determining the patients who meet the inclusion criteria, a randomization program will be used to ensure homogeneous distribution among the groups (Random Allocation Software). A list will be created according to the randomization program and 60 patients included in the study will be assigned to the experimental (30 patients) and control groups (30 patients).
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Collaborators
- Artvin Coruh University
- Responsible party
- Principal investigator, Sevgi DEMIR CAM, Ataturk University
- Investigators
- Sevgi DEMİR ÇAM, Phd Student, Principal investigator, Ataturk UniversityElanur YILMAZ KARABULUTLU, Prof.Dr., Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272891
- Sponsor's protocol ID
- Sevgi Tez
- Status last verified
- Nov 2022
- First submitted
- 4 Feb 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40442032
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Audiobook Application on Anxiety, Depression and Quality of Life in Patients Receiving Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT05272891
- Acronym / sponsor ID
- Sevgi Tez
- Conditions
- Hemodialysis
- Keywords
- Anxiety, Depression, Quality of Life, nurse, Audio book
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Collaborators
- Artvin Coruh University
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After determining the patients who meet the inclusion criteria, a randomization program will be used to ensure homogeneous distribution among the groups (Random Allocation Software). A list will be created according to the randomization program and 60 patients included in the study will be assigned to the experimental (30 patients) and control groups (30 patients).
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: experimental groupaudio book will be played |
| Control Group | No intervention | –No application will be made |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (1 listed)
- Those who want to withdraw from the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental groupAlso: experimental group, audio book appaudio book app | Other | Experimental |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Derived from this study: PubMed 40442032Cam 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.
- Individual participant dataSharing planned: No
Related trials for Hemodialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevgi DEMİR ÇAM, Phd Student principal investigator
Ataturk University
Elanur YILMAZ KARABULUTLU, Prof.Dr. study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group in people with Hemodialysis, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of audio book application on anxiety and depression in patients receiving hemodialysis treatment (time frame: At the end of 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05272891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.