NCT05272891

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

February 4, 2022

Last Update Submit

November 19, 2022

Conditions

Keywords

AnxietyDepressionQuality of LifenurseAudio book

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Experimental

EXPERIMENTAL

audio book will be played

Other: experimental group

Control Group

NO INTERVENTION

No application will be made

Interventions

audio book app

Also known as: experimental group, audio book app
Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Those who want to withdraw from the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hemodialysis units affiliated to Artvin provincial health directorate

Artvin, 08100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Sevgi DEMİR ÇAM, Phd Student

    Ataturk University

    PRINCIPAL INVESTIGATOR
  • Elanur YILMAZ KARABULUTLU, Prof.Dr.

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 4, 2022

First Posted

March 10, 2022

Study Start

April 20, 2021

Primary Completion

May 25, 2022

Study Completion

November 1, 2022

Last Updated

November 22, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations