The aim of this study is to evaluate the effect of music on level of anxiety and vital signs of patients candidate for transesophageal echocardiography. In this study, conducting in Namazi and Faghihi Hospitals, affiliated with Shiraz University of Medical Sciences,70 patients who are eligible to participate in the study, having obtained the written consent, are studied. The patients are selected by convenience sampling and then they are randomly allocated to experimental and control groups. The patients in the experimental group receive music by headphone for 30 minutes about half of an hour before the echocardiography, while the control group does not receive any intervention and the routine care are done for them. Anxiety level is measured by spielberge'sr questionnaire and vital signs (blood pressure, pulse, and respiration) before and after the intervention and for the control group before and after the routine cares.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409148505N9
Registration date:2016-05-31, 1395/03/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-31, 1395/03/11
Registrant information
Name
Seyed Saeed Najafi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1727 7445
Email address
najafisa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2015-10-10, 1394/07/18
Expected recruitment end date
2015-12-09, 1394/09/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of music therapy on anxiety level and Vital Signs of patients candidate for trans esophageal Echocardiography
Public title
The effect of music on patient's anxiety in echocardiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in research;Ability to read and write; Having hemodynamic stability; obtaining 31 points of higher from Spielberg er anxiety questionnaire
Exclusion criteria:history of known mental illness; psychiatric medicine use;Trans esophageal echocardiography cancellation for any reason other than anxiety; withdrawal of patient from the study; hearing disorder; participation in problem solving skill training course;Stress management and yoga in the last 6 months; New crisis like the death of close relatives, Divorce of the patient or his/her parents in the last 6 months; taking sedative and analgesic 3 hours before intervention; Drug addiction; Having pain; Reluctance and unwillingness to listen to music.
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:
70
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
Medical Research Ethics Committee of Shiraz University of Medical sciences Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
71345-1978
Approval date
2015-08-24, 1394/06/02
Ethics committee reference number
IR.SUMS.Rec.1394.286
Health conditions studied
1
Description of health condition studied
transesophageal echocardiography
ICD-10 code
IX
ICD-10 code description
Cardiovascular System Diseases
Primary outcomes
1
Description
anxiety
Timepoint
before music therapy and transesophageal echocardiography and immediately after music therapy
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
1
Description
Blood pressure
Timepoint
before music therapy and transesophageal echocardiography and immediately after music therapy
Method of measurement
sphyngomonometer
Intervention groups
1
Description
Intervention group receives music by headphone for 30 minutes about half of an hour before the esophageal echocardiography
Category
Other
2
Description
The control group receives routing care .
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi & Nemazie hospitals affiliated with Shiraz University of Medical Sciences
Full name of responsible person
Seyed Said Najafi
Street address
N0. 1132, street 23/1 , Valiasr Avenue, Rahmat blvd
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Sayed Basir Hashemi
Street address
Central Building of Shiraz University of Medical Sciences, Zand street , Shiraz Fars Iran, Islamic Republic Of
City
Shiraz
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 of Shiraz 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
Fatemeh(PBUH) School of Nursing and Midwifery, Shiraz University of Medical Sciences,Namazi Square
Full name of responsible person
Hyda rZareipoor
Position
MSc in Nursing
Other areas of specialty/work
Street address
Fatemeh(PBUH) School of Nursing and Midwifery, Shiraz University of Medical Sciences, Namazi Square
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3831 5561
Fax
+98 32122430
Email
hydarezarei@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Saeed Najafi
Position
MS in Nursing
Other areas of specialty/work
Street address
Fatemeh(PBUH) School of Nursing and Midwifery, Shiraz University of Medical Science, Namazi Square Shiraz, Fars Iran, Islamic Republic Of
City
Shiraz
Postal code
71345-1978
Phone
+971 3451978
Fax
+98 32122430
Email
s_najafi44@yahoo.com najafisa@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Seyed Saeed Najafi
Position
MS in Nursing
Other areas of specialty/work
Street address
Fatemeh(PBUH) School of Nursing and Midwifery, Shiraz University of Medical ScienceNamazi Square, Shiraz, Fars Iran, Islamic Republic O
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3727 7445
Fax
+98 32122430
Email
s_najafi44@yahoo.com najafisa@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)