Determining the effect of music on patients performing myocardial perfusion scan in the nuclear medicine ward of Farshchian Hospital in Hamadan
Design
A clinical trial with two arms parallel-group randomized trial, double-blind (blinded on outcome assessor and data analyser) and randomized on 60 patients whose randomization process is performed using the Balanced Block Randomization approach with a block size of four
Settings and conduct
The study will be performed on candidates for myocardial perfusion scan in the nuclear medicine ward of Farshchian Hospital in Hamedan. Blinding will be two-sided on outcome assessors and data analyzer. How to do it randomly among patients who have completed the consent form will be in the test process. The type of music is also considered traditional Iranian music.
Participants/Inclusion and exclusion criteria
The study population is also a candidate for myocardial perfusion scan. Inclusion criteria: 1. Age 25-79 years 2. Having informed consent and exclusion criteria also have hearing problems and inability to read and write and have mental disorders and diseases such as depression and anxiety disorders.
Intervention groups
In the control group, the steps of performing the heart myocardial perfusion scan test were performed routinely, and in the intervention group, in addition to the routine treatments of the desired test, traditional instrumental music was played through headphones during the stress test and imaging and stereo playback during the waiting period from The admission of the patient until the start of the diagnostic modality and the waiting time after the injection until the start of imaging are used.
Main outcome variables
Determining and comparing the mean score of anxiety and stress due to myocardial perfusion scan and parameters related to this test in patients in music therapy group and control group before and after the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220509054797N1
Registration date:2022-09-24, 1401/07/02
Registration timing:registered_while_recruiting
Last update:2022-09-24, 1401/07/02
Update count:0
Registration date
2022-09-24, 1401/07/02
Registrant information
Name
Zahra Shaghaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1720
Email address
z.shaghaghi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of music on patients undergoing myocardial perfusion imaging
Public title
The impact of music on patients undergoing myocardial perfusion imaging
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 25 and 79 years
Referrals to the nuclear medicine department of Farshchian Hospital in Hamadan
Candidate patients undergo myocardial perfusion scan
Exclusion criteria:
Having hearing problems
Inability to read and write
Having mental disorders and diseases
Age
From 25 years old to 79 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, we will use the BalancedBlock Randomization method (block size=4). Random allocation software will be used for this purpose. At first, we prepare two sheets of paper. We write "Intervention" on one paper and "Control" on another. Mix the sheets together and place them in the desk drawer. With the referral of each of the eligible patients, one of the cards will be drawn randomly, and based on this drawn card, it will be assigned to one of the two groups. It should be noted that the drawn sheets will not be returned to the drawer until all four sheets have been removed. After all four sheets are drawn randomly, all the sheets are returned to the drawer and the above operation will be continued for the next four patients until the desired sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor is supposed to measure the outcome in two groups and will be blinded to the allocation of patients to the study groups. Moreover, the data analyzer will be unaware of treatment groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of hamedan university of medical sciences
Street address
Shahid Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2022-03-05, 1400/12/14
Ethics committee reference number
IR.UMSHA.REC.1400.955
Health conditions studied
1
Description of health condition studied
Myocardial perfusion scan
ICD-10 code
**
ICD-10 code description
**
Primary outcomes
1
Description
Severity of phobia
Timepoint
Before and after the intervention
Method of measurement
questionnaire
2
Description
Stress
Timepoint
Measurements at the beginning and end of the test
Method of measurement
questionnaire
3
Description
Anxiety
Timepoint
Measurements at the beginning and end of the test
Method of measurement
questionnaire
4
Description
Exercise Test Distance
Timepoint
during exercise test
Method of measurement
exercise test information
5
Description
Heart Rate
Timepoint
during exercise test
Method of measurement
exercise test information
6
Description
Chronotropic Index
Timepoint
during exercise test
Method of measurement
Mathematical calculations and formulas
7
Description
Heart Rate Recovery Index
Timepoint
Before and after the intervention
Method of measurement
Mathematical calculations and formulas
8
Description
Reduce patient movement
Timepoint
Before and after the intervention
Method of measurement
Expert doctor's opinion
9
Description
Reduce shooting frequency
Timepoint
Before and after the intervention
Method of measurement
Expert doctor's opinion
Secondary outcomes
1
Description
blood pressure
Timepoint
Before and after the intervention
Method of measurement
Barometer
2
Description
Overall feeling of satisfaction
Timepoint
Before and after the intervention
Method of measurement
questionnaire
3
Description
Non-cardiac side effects of dipyridamole
Timepoint
Before and after the intervention
Method of measurement
questinnaire
4
Description
Quality of data collection (Checking the quality of the information obtained from the image)
Timepoint
Before and after the intervention
Method of measurement
Expert doctor's opinion
5
Description
double product
Timepoint
Before and after the intervention
Method of measurement
Mathematical calculations and formulas
Intervention groups
1
Description
Intervention group: Patients will listen to traditional music without words through headphones or stereo playback while performing myocardial perfusion scan tests (such as exercise test or imaging phase). In addition, the desired music will be played during the test and the patients' reaction to the music during the test will be evaluated through parameters such as heart rate, reduction of patient movement, reduction of imaging frequency and data quality. The target group will be exposed to listening to music during all stages of the procedure 1- Waiting time from the patient's admission to the start of the diagnostic modality (listening to music with stereo for 15 minutes from the beginning to the end of this stage) 2- Conducting a stress test (test Exercise (physical) - drug test) (listening to music with headphones for 10 minutes from the beginning to the end of this phase) 3- waiting time after injection until the start of imaging (listening to music with stereo for 10 minutes) From the beginning to the end of this stage (4- imaging stage) (listening to music with headphones for 10 minutes from the beginning to the end of this stage).
Category
Other
2
Description
Control group: Control group: Patients referred to the nuclear medicine department for the perfusion scan test will routinely perform the desired tests. During the physical stress test stage, Exercise Test Distance, Heart Rate, Chronotropic Index, Double product and Heart Rate Recovery Index. During the drug stress test stage, the rate of occurrence of non-cardiac side effects of dipyridamole including headache, dizziness, flushing, chest pain and nausea for both The group is registered. Before performing the stress test, the drugs from beta-lactose and calcium channel blockers are stopped for 48 hours and nitrates for 24 hours. Patients are advised to fast at least 4 hours before. On the day of visit, resting electrocardiogram, blood pressure, and baseline heart rate are recorded, and then for candidate patients, a modality exercise test is performed with a treadmill and Bruce protocol. At the peak of stress or when the exercise test becomes positive, the radiopharmaceutical 99mTc-MIBI is injected and after ten to fifteen minutes, GATED-MPI imaging is performed using a Siemens dual-head gamma camera and using a LEHR collimator. If due to some reasons (old age, fracture, etc.) the patient cannot tolerate physical stress, the patient is a candidate for a pharmacological test. In this condition, the patient's resting electrocardiogram, blood pressure and heart rate are recorded. Then dipyridamole drug is administered during 4 minutes of infusion. During the infusion, the patient's heart rate is monitored, for this purpose, a 12-lead heart rate monitor is used, and the patient's blood pressure and heart rate are recorded at two-minute intervals. In addition, any patient complaints are recorded during this period. In the 6th minute (from the start of the infusion), the patient's blood pressure and heart rate are measured again, and the patient is also asked about the presence of seven different clinical symptoms (headache, dizziness, flushing, chest pain, and nausea). Then, the radiopharmaceutical is injected and an hour later imaging of the patient is done.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital Nuclear Medicine Center
Full name of responsible person
Maryam Alvandi
Street address
Shahid Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
6517839131
Phone
+98 81 3838 1740
Email
hcvc@umsha.ac.ir
Web page address
https://hcvc.umsha.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
Shahid Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
Info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Alvamdi
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Nuclear Medicine
Street address
Shahid Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
maryamalvandi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Alvamdi
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Nuclear Medicine
Street address
Shahid Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
maryamalvandi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Shaghaghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nuclar pharmacy
Street address
Shahid Fahmideh- Hamadan-Iran
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 1720
Fax
+98 81 3838 1686
Email
z.shaghaghi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information can be shared
When the data will become available and for how long
After announcing the results
To whom data/document is available
Everyone
Under which criteria data/document could be used
Provided that the source of the information is mentioned
From where data/document is obtainable
Research team
What processes are involved for a request to access data/document
After the decision of the research team after the announcement to the team