One of the most common complications in patients undergoing invasive cardiac interventions is anxiety. The aim of the study was to investigate the effect of sound therapy on patients’ anxiety, Pain and hemodynamic parameters during percutaneous transluminal coronary angioplasty. This was a randomized controlled trial. A purposive sample of 113 patients who were undergo coronary angioplasty was recruited. Inclusion criteria: being desired for participating in the study; undergoing PTCA for the first time. Patients who chose to withdraw from the study, needed emergency intervention for treating cardiac dysrhythmias, or needed to undergo emergency open-heart surgery were excluded. Patients were randomly allocated to either the control or the experimental groups. we collected patients’ demographic data .The universal pain scale VAS and the anxiety pretest is performed by using the SSAI. In the experimental group, patients received a 20-to-40-minute sound therapy intervention consisted of music (light instrumental music albums by Johann Sebastian Bach and Mariko Makino) and the Quran (Ayatalkorsi) by using a digital MP3 player and a headphone. Patients in the control group received the routine care of the study setting which consisted of no music therapy intervention. Study data were collected by using a demographic questionnaire, the Spielberger’s State Anxiety Inventory consists of twenty questions, Pain scale VAS and a data sheet for documenting hemodynamic parameters. The demographic questionnaire consisted of thirteen items on patients’ demographic characteristics. Patients’ hemodynamic parameters were monitored at five time-points. The anxiety and Pain posttest was also performed thirty minutes after PTCA.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014043014770N2
Registration date:2014-10-03, 1393/07/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-03, 1393/07/11
Registrant information
Name
Masomeh Forooghy
Name of organization / entity
Baghiyatalah University
Country
Iran (Islamic Republic of)
Phone
+98 21 4481 0891
Email address
motahedian@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Faculty of Nursing, Baqiyatallah University of Medical Sciences and Behavioral Research Center, Baqiyatallah University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sound therapy on pain , anxiety level and hemodinamic variables of Patients undergoing Angioplasty coronay
Public title
The effect of sound therapy on pain , anxiety level and hemodinamic variables of Patients undergoing Angioplasty coronay
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria :
undergoing PTCA for the first time; being able to understand and speak Persian; having an age of 40–85 years; having no hearing impairment; hving no drug or alcohol addiction; having no previous history of complicated gross surgeries; receiving no anxiolytic medication during the past six months; having no history of severe psychological disorder during the past six months; needing no emergency cardiac catheterization; Patients with first coronary angioplasty.
Exclusion Criteria:
Patients who chose to withdraw from the study, needed emergency intervention for treating cardiac dysrhythmias ; or needed to undergo emergency open-heart surgery were excluded from the study;
Age
From 40 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
113
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
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Sheikh Bahaee Street, Molasadra Street
City
Tehran
Postal code
Approval date
2014-01-05, 1392/10/15
Ethics committee reference number
34th Session- س 340/3/6770
Health conditions studied
1
Description of health condition studied
Diseases of the circulatory system
ICD-10 code
I70, I79
ICD-10 code description
Diseases of arteries, arterioles and capillaries
Primary outcomes
1
Description
Anexity
Timepoint
befor and after invention
Method of measurement
Spielberger’s State Anxiety Inventory(SSAI)
Secondary outcomes
1
Description
hemodinamic variables and pain
Timepoint
before, during and after
Method of measurement
manitoring and pain Scale VAS
Intervention groups
1
Description
In the experimental group, patients received
sound therapy intervention consisted of music
and the Quran by using a digital MP3 player and a headphone.
Category
Other
2
Description
Patients in the control group received the routine care of the study setting which consisted of no music therapy intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghyatallah Hospital
Full name of responsible person
Elaheh Motahedian Tabrizi
Street address
Education Departeman of Velayat, Arag Squer, Aghdasea
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Baqiyatallah University and Behavioral Sience Research Center, Baqiyat
Full name of responsible person
Mokhtari Jamileh
Street address
Education Departeman of Velayat, Arag Squer, Aghdasea
City
TEHRAN
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 Baqiyatallah University and Behavioral Sience Research Center, Baqiyat
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
Baqiyatallah University
Full name of responsible person
Elaheh Motahedian Tabrizy
Position
PhD in Nursing
Other areas of specialty/work
Street address
Education Departeman of Velayat, Arag Squer, Aghdasea
City
TEHRAN
Postal code
Phone
+98 21 7791 0399
Fax
Email
MOTAHEDIAN.bmsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University
Full name of responsible person
Masoumeh Khaton Forooghy
Position
Critical Care Nursing MCS student
Other areas of specialty/work
Street address
Education Departeman of Velayat, Arag Squer, Aghdasea
City
TEHRAN
Postal code
Phone
+98 21 4481 0891
Fax
Email
forooghy619@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah University
Full name of responsible person
Masoumeh Forooghy
Position
Critical Care Nursing MCS student
Other areas of specialty/work
Street address
Baqiyatallah HASPITAL
City
TEHRAN
Postal code
Phone
+98 21 4481 0891
Fax
Email
forooghy619@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)