Protocol summary

Summary
1-objective: Effectiveness Of Music Therapy.2- Design Of Study: (the insomnia students-interventional group: receive music therapy، control group: not receive music therapy- size of sample: 30- Randomized- Double Blind with control group)3 - Method Of study:experimental group receive music therapy but control group not receive music therapy4-: Inclusion criteria: student of kums with insomnia .exclusion criteria: drug consumtion. sample size:30 -intervention time: 11month - main outcome measures: using music therapy for treatment of insomnia 5-intervention : music therapy

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017040425817N3
Registration date: 2017-09-27, 1396/07/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-27, 1396/07/05
Registrant information
Name
Ali Akbar Parvizi Far
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 330 8692
Email address
aa.parvizif@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University Of Medical Sience
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of music therapy based on traditional Iranian music on insomnia , sleep quality , depression, anxiety and stress in men with primary insomnia
Public title
Effectiveness of music therapy based on traditional Iranian music on insomnia , sleep quality , depression, anxiety and stress in men with primary insomnia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1- student of kums(kermanshah university of medical sience) 2- insomnia patient exclusion criteria : 1- Do not participate in all therapy session
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee in search of Kermanshah University Of Medical Sience
Street address
kermanshah- University Of Medical Sience
City
kermanshah
Postal code
Approval date
2017-03-08, 1395/12/18
Ethics committee reference number
kums.rec.1395.758

Health conditions studied

1

Description of health condition studied
insomnia
ICD-10 code
G470
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnias]

Primary outcomes

1

Description
insomnia
Timepoint
six week after intervention
Method of measurement
Psqi- Isi- DASS

Secondary outcomes

1

Description
depression
Timepoint
six week after intervention
Method of measurement
DASS

2

Description
anxiety
Timepoint
six week after intervention
Method of measurement
DASS

Intervention groups

1

Description
control group: not receiving any specific treatment.
Category
N/A

2

Description
1-intervention group: receiving alive music in 6 session and every session is one hour and listen to tape of music during week
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah University of Medical Siences
Full name of responsible person
ali akbar parvizi fard
Street address
kermanshah- bagh abrisham-
City
kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah university Of Medical Siences
Full name of responsible person
Dr. behrooz hamzeh
Street address
kermanshah- Aiatollah beheshti street- Kermanshah University Of Medical sciences- Deputy of research and technology
City
kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah university Of Medical Siences
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
Kermanshah University Of Medical Siences
Full name of responsible person
Dr. A.A parvizifard
Position
Phd counselling psychology- member of faculty
Other areas of specialty/work
Street address
kermanshah
City
kermanshah
Postal code
Phone
+98 918 330 8692
Fax
Email
aaparvizif@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University Of Medical Siences
Full name of responsible person
Dr. AA. parvizifard
Position
phd counseling psychology
Other areas of specialty/work
Street address
kermanshah- bagh abrisham
City
kermanshah
Postal code
Phone
+98 918 330 8692
Fax
Email
a a p a r v i z i f@ k u m s . a c . ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah university Of Medical siences
Full name of responsible person
Dr. AA parvizifard
Position
phd counseling psychology
Other areas of specialty/work
Street address
City
kermanshah
Postal code
Phone
+98 918 330 8692
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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