Protocol summary

Study aim
The main purpose is determining the effect of music on depression and anxiety in hemodialysis patients referring to Hamedan health centers in 2016
Design
This study is a single-blind, control clinical trial. The samples were selected from patients by available sampling method. Patients who had hemodialysis on even days were in the experimental group and patients who had hemodialysis on odd days were in control group and the total number of samples was 50.
Settings and conduct
This study is conductedon hemodialysis patients referring to Hamedan health centers. For the patients in the intervention group, speechless music is played. Before and after the intervention, the level of anxiety and depression of the subjects is measured by a research collaborator who does not know about the patient's placement in the test and control group.
Participants/Inclusion and exclusion criteria
Entry requirements: being alert; having an active file in the dialysis center; age from 30 to 65 years old; ability to read and write; gain score 30 and above Spielbergers Anxiety Measurement Questionnaire; history of at least three years of dialysis. Exit criteria: hearing problem; unwillingness to participate in the study; taking sedative and anti-anxiety medication; incident or bad experience during the last six months; kidney transplantation or use of peritoneal dialysis methods; drug addiction; psychological problems. History of thyroid gland diseases and the use of drugs that affect it Pregnancy
Intervention groups
For the patients in the experimental group, music is played by headphones for 20 minutes at the start of dialysis. Before and after the intervention, variables are measured. For the control group, routine actions are performed and variables are measured before dialysis and after dialysis.
Main outcome variables
Decrease Anxiety; Decrease depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170619034641N3
Registration date: 2018-06-13, 1397/03/23
Registration timing: prospective

Last update: 2018-06-13, 1397/03/23
Update count: 0
Registration date
2018-06-13, 1397/03/23
Registrant information
Name
Alireza Abdi
Name of organization / entity
nursing and midwifery school, Kermanshah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3725 0111
Email address
arabdi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-05, 1397/04/14
Expected recruitment end date
2018-11-20, 1397/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Music on Depression and Anxiety in Patients Recieving Dialysis in Beheshti Hospital, in Hamedan city, Iran in 2016
Public title
The Effect of Music on Depression and Anxiety in Patients Recieving Dialysis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being alert Having an active file in the dialysis center Age from 30 to 65 years old Ability to read and write Hemodynamic stability Gain score 30 and above Spielbergers Anxiety Measurement Questionnaire History of at least three years of dialysis
Exclusion criteria:
Hearing problem Unwillingness to participate in the study Any illness or severe disability (other than diabetes and high blood pressure) Age under 30 and over 65 years Taking sedative and anti-anxiety medication Incident or bad experience during the last six months Kidney transplantation or use of peritoneal dialysis methods Drug Addiction History of epilepsy Psychological problem History of thyroid gland diseases and the use of drugs that affect it Pregnancy The habit of listening to music It was unwilling and unwilling to listen to music Patient death
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The sample was selected from patients by available sampling method and the patients were randomly assigned into two groups of control and intervention(no verbal music). Patients who had Hemodialysis in even days were in the intervention group and patients who had hemodialysis on odds day were in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
A research fellow that responsible for measuring the variables of depression and anxiety was waiting outside the room for hemodialysis .He did not know the group in which the patients were located. He then entered the room and measured and recorded the rate of depression and anxiety
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Shaheed Beheshti Hospital, Mahdieh Street, Ghaem Square
City
Hamedan
Province
Hamadan
Postal code
6541675517
Approval date
2018-05-08, 1397/02/18
Ethics committee reference number
ir.kums.rec.1397.032

Health conditions studied

1

Description of health condition studied
Chronic renal failure
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
Depression Score in the Beck Questionnaire
Timepoint
Measuring depression before intervention and after the completion of dialysis
Method of measurement
Beck Depression Questionnaire

2

Description
Anxiety Scale in the Spielberger Questionnaire
Timepoint
Measuring anxiety before intervention and after the completion of dialysis
Method of measurement
Spillberger's Anxiety Questionnaire

Secondary outcomes

1

Description
Anxiety Score
Timepoint
Before the intervention and after dialysis
Method of measurement
Spillberger's Anxiety Inventory

Intervention groups

1

Description
Intervention group: the duration of the intervention period for the test group is 4 weeks, and each week for three days, each day for 20 minutes, music is played to the patient by headphones. Variables are measured and recorded each time before and after dialysis.
Category
Lifestyle

2

Description
Control group: patients in the control group receive the usual measures of the department, and variables are measured before dialysis and after dialysis
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mohamad Imani
Street address
Shaheed Beheshti Hospital, Mahdieh Street, Ghaem Square
City
Hamedan
Province
Hamadan
Postal code
6541675517
Phone
+98 81 1254 3265
Fax
Email
fmomenfar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Street address
Vice Chancellor for Research, Kermanshah University of Medical Sciences, Shahid Beheshty Blv., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
00988338279394
Phone
+98 83 3835 8258
Email
arabdi@kums.ac.ir
Grant name
Vice Chancellor for Research, Kermanshah University of Medical Sciences
Grant code / Reference number
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی کرمانشاه
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Parvin Abasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kermanshah University of Medical Sciences, Shariati St., Kuy Dolat Abad
City
Kermanshah
Province
Kermanshah
Postal code
00988338279394
Phone
+98 83 3427 6489
Email
P-abasi2003@kums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Parvin Abasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kermanshah University of Medical Sciences, Shariati St., Kuy Dolat Abad
City
Kermanshah
Province
Kermanshah
Postal code
00988338279394
Phone
+98 83 3427 6489
Email
P-abasi2003@kums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Parvin Abasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kermanshah University of Medical Sciences, Shariati St., Kuy Dolat Abad
City
Kermanshah
Province
Kermanshah
Postal code
00988338279394
Phone
+98 83 3427 6489
Email
P-abasi2003@kums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
if the desired journal or research deputy will request the data, the file will be in their disposal.
When the data will become available and for how long
after two years from data collection
To whom data/document is available
research deputy of KUMS, and editor in chief of the raised journal
Under which criteria data/document could be used
to publish the paper and offering the final report of the project
From where data/document is obtainable
contact to corresponding author
What processes are involved for a request to access data/document
request via email
Comments
Loading...