Investigate the effect of music on dyspnea, anxiety and depression in patients with chronic obstructive pulmonary disease
Design
The clinical trial has a one-way blinded and control group
Settings and conduct
Music will be played for Intervention group during exercise test in Pasteur Hospital. Researchers and outcome assessors are unaware of intervention and control group.
Participants/Inclusion and exclusion criteria
1. Confirmation of diagnosis of moderate to severe COPD by a pulmonary specialist according to criteria Global Initiative for Chronic Obstructive Lung Disease (GOLD)criteria. 2 -70-45 years -3 BMI less than 30; 4-non existance of Nervous System Diseases, Cancer and Myocardial Infarction; No Psychiatric Disorder; 5- Having literacy in reading and writing, 6- Having a fixed medication regimen (Salmeterol spray 2 puffs every 12 hours, Atrovent spray 2 puffs every 6 hours. Exclusion criteria 1- non-cooperative Patient 2- positined in Acute phase of disease
Intervention groups
Intervention and control groups should walk for 6 minutes which is followed by pre-test and then each group walk for 10 minutes and no music will be played in the control group. The post-test questionnaires are filled.Music is played for the intervention group plays music and the stage after the test is completed by filling out the questionnaires.
Main outcome variables
Music Effectiveness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111019007844N14
Registration date:2020-04-06, 1399/01/18
Registration timing:registered_while_recruiting
Last update:2020-04-06, 1399/01/18
Update count:0
Registration date
2020-04-06, 1399/01/18
Registrant information
Name
Mansour Arab
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1320 5179
Email address
marab@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-19, 1398/11/30
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of effect of music on dyspnea, anxiety and depression during exercise in individuals with chronic obstructive pulmonary disease
Public title
The effect of music on dyspnea,anxiety and depression
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic obstructive pulmonary disease of moderate to severe
Exclusion criteria:
Patient not positioned in a specified age range
Age
From 45 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a randomized controlled clinical trial.The samples are selected using available sampling method and according to entry conditions. They
are assigned to two groups of music and control using random allocation method.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher and outcome assessors are kept blind in this study and Patients are awake that they being studied due to ethical issues
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bam University of Medical sciencel Sciences
Street address
newarge
City
Bam
Province
Kerman
Postal code
7618147867
Approval date
2019-03-16, 1397/12/25
Ethics committee reference number
IR.MUBAM.REC.1398.066
Health conditions studied
1
Description of health condition studied
Dyspnea
ICD-10 code
R06.0
ICD-10 code description
Dyspnea
2
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
3
Description of health condition studied
Depression
ICD-10 code
F06.31
ICD-10 code description
Mood disorder due to known physiological condition with depressive features
Primary outcomes
1
Description
Depression score based on questionnaire PHQ8
Timepoint
Before of the intervention and after of the intervention
Method of measurement
PHQ8 questionnaire
2
Description
Anxiety score based on Spielberger anxiety questionnaire
Timepoint
Before of the intervention and after of the intervention
Method of measurement
Spielberger anxiety questionnaire
3
Description
Borg's dyspnea scale
Timepoint
Before of the intervention and after of the intervention
Method of measurement
Borg's dyspnea scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group should walk for 6 minutes which is followed by pre-test and walk for 10 minutes . music played for the intervention during exercise and the stage after the test is completed by filling out the questionnaires
Category
Rehabilitation
2
Description
Control group:control groupshould walk for 6 minutes and then followed by pre-test and then walk for 10 minutes and no music will be played in the control group. The post-test questionnaires are filled.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Bam Pastour Hospital
Full name of responsible person
Dr. Ali Radfer
Street address
Pastor Hospital., Persian Gulf Blvd., Bam-Baravtat Road., Bam
City
Bam
Province
Kerman
Postal code
76197745
Phone
+98 34 4431 9403
Fax
+98 34 4431 9403
Email
A.radfar@mubam.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Dr Fariba Borhani
Street address
Bam University of Medical Science., Shahid Rajaiee Blvd., Sardaran Shahid Square., Bam City
City
Bam
Province
Kerman
Postal code
7667548912
Phone
+98 34 4431 9403
Email
A.radfar@mubam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bam 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
Bam University of Medical Sciences
Full name of responsible person
Ali Radfar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Pastor Hospital., Persian Gulf Blvd., Bam-Baravat Road., Bam
City
Bam
Province
Kerman
Postal code
7665981242
Phone
+98 34 4431 9402
Email
A.radfar@mubam.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Dr Ali Radfar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Pastor Hospital., Persian Gulf Blvd., Bam-Baravat Road., Bam
City
Bam
Province
Kerman
Postal code
7665984512
Phone
+98 34 4431 9402
Email
A.radfar@mubam.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Ali Radfar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Pastor Hospital., Persian Gulf Blvd., Bam-Baravat Road., Bam
City
Bam
Province
Kerman
Postal code
7698451265
Phone
+98 34 4431 9402
Email
A.radfar@mubam.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
publishing article
When the data will become available and for how long
The year 1400
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Contact to the researcher
From where data/document is obtainable
E-mail to Dr. Ali Radfar@gmail.com
What processes are involved for a request to access data/document
We will respond by e-mail one week after the request