Protocol summary

Summary
Study purpose: to determine the effect of music on the intake of analgesics and sedative drug in patients with coronary artery bypass graft surgery unit. Inclusion criteria: no drug abuse; no hearing impairment; absence of chronic pain; prescription painkillers and sedatives as needed (PRN); patients with an age range of 35 to 80 years old. Exclusion criteria: unwillingness of patients to continue to participate in the study; patients with a history of psychiatric disorders and anxiety; patients with sensory disorders; patients with a history of recent surgery; the duration of weaning from ventilator more than a day; listening to music during the study in the control group. The study population included all patients admitted to the intensive care unit open heart surgery, Shariati Hospital in Tehran from February to May 2014. Participants included 50 patients, open heart surgery were randomly assigned to two groups of intervention and control. The intervention consisted of 4 sessions of music listening with Hands free in the two firths day after surgery; each day we use two sessions, one in morning and one in the afternoon and each session include 30 minute. It should be mentioned that patients choice their interest music from the list that before selected by researcher and had the tempo between 60 - 80 beat / min .at the end of study we will comparison the amount of analgesic and sedative drug between control and intervention group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015042621960N1
Registration date: 2015-06-22, 1394/04/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-22, 1394/04/01
Registrant information
Name
Shahram Ghorbani
Name of organization / entity
Gazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7711 3346
Email address
sh.ghorbani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Gazvin University of Medical Sciences
Expected recruitment start date
2015-01-30, 1393/11/10
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of the music on amount of analgesic and sedative medicines intake after coronary artery bypass graft in patients of Cardiac Surgery ward of shariati hospital of Tehran city in 2014
Public title
The Effect of the music on amount of analgesic and sedative medicines intake
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: no drug abuse; no hearing impairment; absence of chronic pain; prescription painkillers and sedatives as needed (PRN); patients with an age range of 35 to 80 years old. Exclusion criteria: unwillingness of patients to continue to participate in the study; patients with a history of psychiatric disorders and anxiety; patients with sensory disorders; patients with a history of recent surgery; the duration of weaning from ventilator more than a day; listening to music during the study in the control group.
Age
From 35 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar Boulevard
City
Qazvin
Postal code
3419759811
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
5/20/9887

Health conditions studied

1

Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
analgesic and sedative drugs
Timepoint
One day before intervention until two days after intervention
Method of measurement
The number of doses of the drug

Secondary outcomes

1

Description
respiration
Timepoint
Before the intervention and after intervention
Method of measurement
The number of breaths per minute

2

Description
heart rate
Timepoint
Before the intervention and after intervention
Method of measurement
The number of heart rate per minute

3

Description
blood pressure
Timepoint
Before the intervention and after intervention
Method of measurement
MmHg

4

Description
pain score
Timepoint
Before the intervention and after intervention
Method of measurement
pain scale score

Intervention groups

1

Description
Intervention group: listening to music in the first two days after surgery, each time for 30 minutes in the morning and afternoon. It is mentioned additional interference when listening to music is not performed on patients. Before the intervention, the pain using a numeric scale of pain and heart rate, RR that can be measured as a measure to reduce the pain. Upon completion of this measure and music above the pre comparison. It is mentioned in the above-mentioned measure only once the intervention sessions
Category
Other

2

Description
Control group: in the first two days after surgery once the heart rate and respiratory rate per minute as well as the intensity of pain was measured using a scale score for pain. And then after half an hour without intervention the patient is re-measured and these values were compared with the previous findings of the study group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Shariati Hosoital
Full name of responsible person
shahram ghorbani (master student of nursing)
Street address
Dr. Shariati Hospital, North Karegar Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Taghi Naserpoor Farivar
Street address
Qazvin University of Medical Sciences, Bahonar boulevard
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Shahram Ghorbani
Position
Master student of nursing
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar boulevard
City
Qazvin
Postal code
3419759811
Phone
+98 28 1334 4268
Fax
Email
shahramghorbani100@yahoo.com
Web page address
www.qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mostafa Shokati Ahmadabad
Position
Nursing Ph.D.
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar boulevard
City
Qazvin
Postal code
3419759811
Phone
+98 28 1334 4268
Fax
Email
mostafa.shokati@gmail.com
Web page address
www.qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Shahram Ghorbani
Position
Master student of nursing
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar boulevard
City
Qazvin
Postal code
3419759811
Phone
+98 28 1334 4268
Fax
Email
shahramghorbani100@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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