The main objective is to compare the effect of ear pluge and music reducing anxiety in patients candidate for elective cesarean under spinal anesthesia. This study is a single blind prospective clinical trial and is conducted on 90 pregnant women (with no history of psychiatric and hearing problems) whom candidate elective cesarean under spinal anesthesia enrolled randomly to three groups (control group, ear plug group and music group). Patients underwent trait anxiety inventory score (STAI-TA) testing before surgery to determine the property based anxiety. Before and after intervention, anxiety is measured and recorded by using Ashpyl Berger questionnaires. Data is then statistically analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205201617N6
Registration date:2013-05-07, 1392/02/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-07, 1392/02/17
Registrant information
Name
Mansour Choubsaz
Name of organization / entity
Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 83 1724 6708
Email address
mchoubsaz@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences and health Services
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of ear plug versus music on anxiety reduction in elective cesarian section patients undergoing spinal anesthesia
Public title
Ear plug versus music on anxiety reduction in elective cesarian section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA class1 & 2; pregnant women candidates for elective cesarean section second delivery; agree to participate in the study. Exclusion criteria: a history of psychiatric disease or psychotropic drug consumption hearing.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Kermanshah University of Medical Sciences
Street address
Pro-Vice-Chancellor for Research, Kermanshah University of Medical Sciences Kermanshah Kermanshah Iran, Islamic Republic Of
City
Kermanshah
Postal code
Approval date
2012-12-29, 1391/10/09
Ethics committee reference number
45283
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41
ICD-10 code description
anxiety disorders
Primary outcomes
1
Description
Anxiety
Timepoint
0, 1 and 6 hours
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Blood pressure
Timepoint
0 and 30 minutes and 1 and 6 hours
Method of measurement
Automated blood pressure monitor
2
Description
Heart rate
Timepoint
0 and 30 minutes and 1, 2 and 6 hours
Method of measurement
Pulse oximetry
Intervention groups
1
Description
The first group in added to common medical care , Patients ear is occlude with foam earplugs protection
Category
Other
2
Description
The control group received usual medical care
Category
N/A
3
Description
The third group in added to common medical care hear calming music by headphones
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences and Health Services IMAM REZA hospital
Full name of responsible person
Dr. Farid Najafi
Street address
Imam Reza hospital-Zakaria boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences and health Services q
Full name of responsible person
Mohammad Reza Nikbakhat
Street address
Kermanshah University of Medical Sciences and health Services
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 Sciences and health Services q
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 Sciences and Heaith Services
Full name of responsible person
Azadeh Bayat
Position
MD, resident of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesia and intensive care, Imam Reza Hospital
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@kums.ac.ir; mchoobsaz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences and Heaith Services
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist/Assistant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences and Health Services
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@kums.ac.ir mchoobsaz@yahoo.com
Web page address
www.kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences and Heaith Services
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist/Assistant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences and Heaith Services
City
Kermanshah
Postal code
Phone
+98 83 1427 6708
Fax
+98 83 1724 4969
Email
mchoubsaz@kums.ac.ir; mchoobsaz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)