Does slow and fast music have an effect on reducing anxiety and improving the quality of life of people with MS?
Design
The statistical population consists of people with multiple sclerosis referring to Shiraz MS Association and 45 people will be randomly selected and if they do not take anti-anxiety medication, they will complete Beck's anxiety questionnaire and if their anxiety score is more than 7, they will enter the project. They will be. The selected people will be divided into two experimental and control groups. The test group will be placed in fast music group (15 people) and slow music group (15 people). For the pre-test, 45 selected people will be given anxiety and quality of life questionnaires, and then the intervention sessions will begin.
Settings and conduct
The intervention is carried out in Shiraz MS Association and the experimental group is subjected to 14 sessions of 20-minute passive music therapy by listening to soft songs and the next group by listening to loud songs. The control group does not receive any educational and therapeutic intervention.
Participants/Inclusion and exclusion criteria
People with Multiple Sclerosis / Entry condition: Not taking anti-anxiety medication and having a score higher than 7 in Beck's anxiety questionnaire
Intervention groups
The first intervention group is listening to music with a fast rhythm, the second intervention group is listening to music with a slow rhythm, and the third group is the control group, which does not receive any educational or therapeutic intervention.
Main outcome variables
Reducing the anxiety of people with multiple sclerosis
Increasing satisfaction with existing conditions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230219057455N1
Registration date:2023-06-16, 1402/03/26
Registration timing:registered_while_recruiting
Last update:2023-06-16, 1402/03/26
Update count:0
Registration date
2023-06-16, 1402/03/26
Registrant information
Name
Foroogh Safari
Name of organization / entity
Islamic Azad University of Shiraz
Country
Iran (Islamic Republic of)
Phone
+98 71 5356 1996
Email address
foroogh.safari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-27, 1402/03/06
Expected recruitment end date
2023-07-28, 1402/05/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of slow and fast music on anxiety and quality of life of people with multiple sclerosis
Public title
The effect of slow and fast music on anxiety and quality of life of people with multiple sclerosis
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
People who have MS and do not take anti-anxiety medication and their anxiety score is higher than 7 in the Beck Anxiety Questionnaire.
Exclusion criteria:
People who do not have psychosis and do not have mental balance
Age
From 15 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Islamic Azad University of Shiraz
Street address
Qasem Ghaedi Ave, Rezvan Street, Faz 1, Darab
City
Darab
Province
Fars
Postal code
7491693995
Approval date
2023-05-15, 1402/02/25
Ethics committee reference number
IR.IAU.SHIRAZ.REC.1402.005
Health conditions studied
1
Description of health condition studied
Anxiety and quality of life in multiple sclerosis patients
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety score in Beck's questionnaire
Timepoint
The beginning of the study and the end of the 14 intervention session
Method of measurement
Beck's anxiety questionnaire
2
Description
Quality of life score in the quality of life questionnaire
Timepoint
The beginning of the study and the end of the 14 intervention session
Method of measurement
Quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: passive music therapy by listening to fast music, The second intervention group: passive music therapy by listening to calm music.
Category
Other
2
Description
Control group: does not receive any educational and therapeutic intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
MS society of Shiraz
Full name of responsible person
Foroogh Safari
Street address
Ghasem Ghaedi Ave, Rezvan Street, Faz 2, Darab
City
Darab
Province
Fars
Postal code
7481693995
Phone
+98 917 134 1090
Email
Foroogh.Safari@Gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Foroogh Safari
Street address
Ghasem Ghaedi Ave, Rezvan Street, Faz 2, Darab
City
Darab
Province
Fars
Postal code
7481693995
Phone
+98 71 5356 1996
Email
Foroogh.Safari@Gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz university of medical sciences
Proportion provided by this source
1
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Foroogh Safari
Position
Master's student in clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ghasem Ghaedi Ave, Rezvan Street, Faz 2, Darab
City
Darab
Province
Fars
Postal code
7481693995
Phone
+98 71 5356 1996
Email
Foroogh.Safari@Gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Foroogh Safari
Position
Master's student in clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ghasem Ghaedi Ave, Rezvan Street, Faz 2, Darab
City
Darab
Province
Fars
Postal code
7481693995
Phone
+98 71 5356 1996
Email
Foroogh.Safari@Gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Foroogh Safari
Position
Master's student in clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ghasem Ghaedi Ave, Rezvan Street, Faz 2, Darab
City
Darab
Province
Fars
Postal code
7481693995
Phone
+98 71 5356 1996
Email
Foroogh.Safari@Gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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