The objective of this clinical trial is to assess the effect of classical music on preoperative level of anxiety in elderly clients who undergone cataract surgery in Imam Ali Hospital, Bojnoord.126 patients aged 90-60 years undergoing cataract surgery who have not mental disorder and being able to understand and speak in Persian language and hear sound from the headphones will be randomly divided into experimental and control groups.On arrival at the operating room, vital signs will be measured and STAI anxiety questionnaires will be completed in both groups. Experimental group would be listening to piano music's in a relaxed environment for 15 minutes via headphones. At the end of this period, vital signs will measured and questionnaires would be completed for both groups. Results will be analyzed by using spss software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122420417N1
Registration date:2015-06-02, 1394/03/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-02, 1394/03/12
Registrant information
Name
Azadeh Kamali
Name of organization / entity
North Khorasan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 7097
Email address
azade.kamali@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Student Research Committee, North Khorasan University of Medical Sciences
Expected recruitment start date
2015-02-19, 1393/11/30
Expected recruitment end date
2015-06-20, 1394/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of classic Music on level of Anxiety Among Elderly Clients before Cataract Surgery
Public title
Effect of Music on Level of Anxiety Before Cataract Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are in selected age group; without known mental and brain disorders; being able to understand and speak Persian language; alert patients; not use any kind of opium prior to this study; being able to hear voices through headphone; willingness to participate in the study
Exclusion Criteria: no willingness to participate in the study; have sensory and hearing disorders; filling any vertigo or headache during study
Age
From 60 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
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
Student Research Committee, North Khorasan University of Medical Sciences
Street address
Student Research Committe, Berenji Street, Shahid Sq., Bojnord
City
Bojnord
Postal code
Approval date
2013-12-25, 1392/10/04
Ethics committee reference number
693/پ/92
Health conditions studied
1
Description of health condition studied
cataract
ICD-10 code
H26.9
ICD-10 code description
Cataract, unspecified
Primary outcomes
1
Description
State Anxiety
Timepoint
At the first time and after listening to music
Method of measurement
SpielbergerAnxiety Questionnaire
2
Description
Trait Anxiety
Timepoint
At the first time and after listening to music
Method of measurement
SpielbergerAnxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group will be listening to piano music in a relaxed environment for 15 minutes via headphones
Category
Other
2
Description
No intervention will be done in control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam ali hospital
Full name of responsible person
Azadeh Kamali
Street address
ShahriarAvenue, Bojnord
City
Bojnord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Student Research Committee, North Khorasan University of Medical Sciences
Full name of responsible person
Masomeh Taher Poor
Street address
Student Research Committe, Berenji Street, Shahid Sq., Bojnord
City
Bojnord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Student Research Committee, North Khorasan 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
Faculty of Health Sciences, North Khorasan University of Medical Sciences
Full name of responsible person
Masoomeh Taher poor
Position
Master of Biostatistics, Lecturer
Other areas of specialty/work
Street address
Tleghani Street, Faculty of Health Sciences, Bojnord
City
Bojnord
Postal code
Phone
+58 32297097
Fax
Email
azadehkamali58@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
faculty of nursing and midwifery
Full name of responsible person
Azadeh Kamali
Position
master of nursing- lecturer
Other areas of specialty/work
Street address
faculty of nursing and midwifery- Bojnord
City
Bojnord
Postal code
Phone
+58 32297097
Fax
Email
azadehkamali58@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
faculty of health sciences
Full name of responsible person
Masoomeh taher poor
Position
master of sciences- lecturer
Other areas of specialty/work
Street address
faculty of health sciences- Bojnord
City
Bojnord
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)