This Study was a crossover, single blind clinical trial that carried out on all available hemodialysis patients of Valliasr Hospital of Arak-Iran. 102 patients were eligible according to inclusion criteria such as: 1-Patients came for hemodialysis with any causes. 2 - Age between 20-80 years. 3- Patients with any kinds of disorders that music is harmful for them. 4-Paients acceptance of participation in study, and exclusion criteria such as: 1 - Patients who were used to music. 2 - Patients who used any kinds of substances and psychiatric drugs. 3- Patients who were suffering from hearing disorders. They were randomly divided into two groups and take intervention in crossover manner. Intervention period: hearing music during hemodialysis for 3 hours through a single MP3- Player with relaxation music phone without word of choice so that they can manage this process. Control period: the same way but without music. Wash out period: two weeks. We measured anxiety and depression at the beginning and end of hemodialysis as a Pre and Post-test that were evaluated by shpill-berger (Triat - State) anxiety scale and Beck Depression Inventory test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012165142N2
Registration date:2011-02-10, 1389/11/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-10, 1389/11/21
Registrant information
Name
Bahman Salehi
Name of organization / entity
Arak University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 1610
Email address
dr.salehi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for reseach, Arak University of Medical Siences
Expected recruitment start date
2010-01-30, 1388/11/10
Expected recruitment end date
2010-04-09, 1389/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Music on Reduction of Anxiety and Depression of Patients During the Hemodialysis in Valliasr Hospital of Arak-Iran
Public title
Effect of music on anxiety and depression during dialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria such as: 1-Patients came for hemodialysis with any causes. 2 - Age between 20-80 years. 3- Patients with any kinds of disorders that music is harmful for them. 4-Paients acceptance of participation in study. Exclusion criteria such as: 1 - Patients who were used to music. 2 - Patients who used any kinds of substances and psychiatric drugs. 3- Patients who were suffering from hearing disorders.
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Pardiss site, Basije Square
City
Arak
Postal code
6941-7-38481
Approval date
2009-10-11, 1388/07/19
Ethics committee reference number
7-61-88
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
2
Description of health condition studied
Anxiety
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Reduction of anxeity and Depression
Timepoint
Before and After intervention and then After 2 weeks (wash-out)
Method of measurement
Shpill-burger (Trait-State) anxeity scale and Beck depression inventory scale
Secondary outcomes
empty
Intervention groups
1
Description
Control period: The same way but without music.
Category
N/A
2
Description
Intervention period: Hearing music during hemodialysis for 3 hours through a single MP3- Player with relaxation music phone without word of choice so that they can manage this process.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valliasr Hospital, Hemodialysis ward
Full name of responsible person
Dr.Bahman-Salehi
Street address
Valliasr Sqaure
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Dr. Saeeid Chagizi Ashtiyani
Street address
Pardiss site of Arak University of Medical Sciences, Basige squre
City
Arak
Grant name
طرح مصوب تفویض اختیاری دانشکده پزشکی اراک
Grant code / Reference number
375
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Bahman Salehi
Position
Psychiatric Associate Proffesor of Arak University of Medical Sciences
Other areas of specialty/work
Street address
No.6165, Shahid Moharek Poor St., Alamalhoda St.
City
Arak
Postal code
3819696165
Phone
+98 86 1313 1610
Fax
+98 86 1417 3639
Email
dr.salehi@arakmu.ac.ir
Web page address
http://www.arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Bahman Salehi
Position
Psychiatric Associate Proffesor of Arak University of Medical Sciences
Other areas of specialty/work
Street address
No. 6165, Moharek-Poor St., Alamalhoda St.
City
Arak
Postal code
3819696165
Phone
+98 86 1313 1610
Fax
+98 86 1417 3639
Email
dr.salehi@arakmu.ac.ir
Web page address
http://www.arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences- Psychiatric ward
Full name of responsible person
Dr. Bahman Salehi
Position
Psychiatric Associate Professor of Arak University of Medical Sciences
Other areas of specialty/work
Street address
No.6165, Shahid Moharek-Poor St., Alamalhoda St.,
City
Arak
Postal code
3819696165
Phone
+98 86 1313 1610
Fax
+98 86 1417 3639
Email
dr.salehi@arakmu.ac.ir
Web page address
http://www.arak.mu.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)