This study is done to compare the effects of relaxation and music therapy on anxiety of before angiography in patients who are hospitalized in cardiac ward of Shiraz hospitals. This study is done on 105 patients according to inclusive criteria who are undergoing coronary angiography for the first time and Exclusion criteria of not doing angioplasty. Sample are selected with easy method and then randomly assigned to three groups (music and relaxation) and control. The relaxation is done in supine position such that first the legs muscles are contracted separately and then released and then the hands and chest muscles and back and at last the face in the same order as last become contract and expand. In music therapy method by using M P 3 Player the sound of the sea, the rain, the water is discharged to a patient. In the control group performed a particular action. In each group, the actions carried out for 20 minutes and the patient's anxiety is considered by Speilberger questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121111230N2
Registration date:2016-04-07, 1395/01/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-07, 1395/01/19
Registrant information
Name
Zahra Pourmovahed
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1751
Email address
z_pourmovahed@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chanceller for research Shahid sadoughi University of Medical Sciences of Yazd
Expected recruitment start date
2015-12-21, 1394/09/30
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the effects of relaxation and music therapy on anxiety before angiography
Public title
The effect of relaxation and music therapy on anxiety before angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
for the first time undergoing Angiography;Angiograghy without Angioplasty; before angiography the patient not having echo from esophagous; not Having valvular heart disease; the patient be full conscious without critical situation; like both methods:relaxation and music therapy; like to participate to the study;more than 18 years old
not having hearing impairment and movement disorder;
not having mental disorder and not using Muscle relaxants, not using sedatives and psychotropic substances;not using narcotics and not having thyroid disease; The patient not using anti anxiety drugs; the patients must be selected that hospitalized one day before for doing angiography
;
Exclusion criteria : like to listen to music;not like to continue the study; patients who have angioplasty is removed
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The samples were randomly assigned to three groups (music and relaxation) and control for this work used the cards on which the words C, M, R was written and placed in a box
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid SadoughiYazd University of Medical Sciences
Street address
Shahid Sadoughi Yazd University of Medical Sciences organizaftion, shahid Dr. bahonar squre,Yazd
City
YAZD
Postal code
8916978477
Approval date
2015-06-01, 1394/03/11
Ethics committee reference number
ir.ssu.rec.1394.12
Health conditions studied
1
Description of health condition studied
STRESS before Angiography
ICD-10 code
-R00-R09
ICD-10 code description
Symptoms and signs involving the circulatory and respiratory systems
Primary outcomes
1
Description
Anxiety
Timepoint
before intervention- after intervention
Method of measurement
Speilberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: music is play to the patient for 20 minutes with the sound of sea، rain and water
Category
Behavior
2
Description
Intervention group2: Relaxation of muscles (relaxation after stress) is also taught to patients in this way that the patient lying in supine position and contracted the muscles and then released them .This will be done with supervision for 20 minutes
Category
Behavior
3
Description
control group: In control group no intervention is done
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
galbe alzahra hospital
Full name of responsible person
Farzaneh Mozaffari
Street address
Number 244, Razi street, Shiraz
City
SHIRAZ
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahid SadoughiYazd University of Medical Sciences
Full name of responsible person
zahra pourmovahed
Street address
Faculty of Nursing and Midwifery, SafaiehStreet, Yazd
City
Yazd
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 Shahid SadoughiYazd 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
Shahid SadoughiYazd University of Medical Sciences
Full name of responsible person
zahra pourmovahed
Position
Master of Nursing ، PhD research student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery، Safaieh Street، Yazd
City
Yazd
Postal code
Phone
+98 353841752
Fax
Email
Z_pourmovahed@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid SadoughiYazd University of Medical Sciences
Full name of responsible person
Zahra pourmovahed
Position
Master of Nursing، PhD research student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery، Safaieh Street، Yazd
City
Yazd
Postal code
Phone
+98 353841752
Fax
Email
z_pourmovahed@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid SadoughiYazd University of Medical Sciences
Full name of responsible person
Zahra pourmovahed
Position
Master of Nursing، PhD research student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery ، SafaiehStreet، Yazd
City
Yazd
Postal code
Phone
+98 353841752
Fax
Email
z_pourmovahed@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)