In a clinical trial 62 patients that referred to Apadana Hospital and were candidate for LASIK were evaluated. Aim of this study is to determine state and trait anxiety and compare them in intervention and control group. A Spielberg questionnaire for measuring level of anxiety was used and filled out by patients in 2 times. The first time one hour before LASIK operation that represents the basic anxiety and second time after intervention, before LASIK. For intervention group in a separate room,one hour before LASIK music therapy is performed by a psychiatric assistant for 45 minutes. participants should able to communicate, and can speak Farsi and Exclusion criteria like having cognitive problem, and if they had history of major psychological disorder and cognitive problem, they were excluded. music therapy will be used by Instrumental pieces from the sounds of nature like the sound of sea waves and are inspired by the sounds of the forest. State Anxiety is evaluated feeling at this moment and that response time and Trait anxiety is evaluated public sentiment and the usual measures. For control group in a separate room without playing music, are preparing for LASIK. participants should able to communicate, and can speak Farsi and Exclusion criteria like having cognitive problem, and if they had history of major psychological disorder and cognitive problem, they were excluded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122831626N1
Registration date:2017-01-18, 1395/10/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-18, 1395/10/29
Registrant information
Name
Hatam Boostani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
tabibi.y@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of music therapy on anxiety level of patients undergoing LASIK eye surgery before operation
Public title
The effect of music therapy on anxiety level of patients undergoing LASIK eye surgery before operation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 18-40 years؛ the language Farsi؛ the ability to communicate verbally؛ with no history of previous LASIK; a consent to enter the scheme.
Exclusion criteria: the risk of dementia؛ mental retardation؛ distinctive physical problems that interfere consultation; history of major psychiatric disorders؛ that the patients is not cooperative.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was done by random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Approval date
2016-08-12, 1395/05/22
Ethics committee reference number
IR.AJUMS.REC.1395.326
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F40,F41,F4
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
State Anxiety
Timepoint
Before intervention- After intervention
Method of measurement
Spielberg questioner
Secondary outcomes
1
Description
Trait Anxiety
Timepoint
Before intervention- After intervention
Method of measurement
Spielberge questioner
Intervention groups
1
Description
Intervention group: A Spielberg questionnaire for measuring level of anxiety was used and filled out by patients in 2 times. The first time one hour before LASIK operation that represents the basic anxiety and second time after intervention, before LASIK. For intervention group in a separate room,one hour before LASIK music therapy is performed by a psychiatric assistant for 45 minutes. music therapy will be used by Instrumental pieces from the sounds of nature like the sound of sea waves and are inspired by the sounds of the forest. State Anxiety is evaluated feeling at this moment and that response time and Trait anxiety is evaluated public sentiment and the usual measures.
Category
Behavior
2
Description
Control group: The control group in a separate room without playing music, are preparing for LASIK.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Apadana treatment centre
Full name of responsible person
Hatam Boostani
Street address
Ghods highway, South Soroosh St, Kampoloo, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hatam Boostani
Street address
Golestan Hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hatam Boostani
Position
Assistant Professor
Other areas of specialty/work
Street address
Golestan Hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
Boostani_h@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hatam Boostani
Position
Assistant Professor
Other areas of specialty/work
Street address
Golestan hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
boostani_h@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Yasaman Tabibi
Position
Assistant
Other areas of specialty/work
Street address
Golestan hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
Dr.y_tabibi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)