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IRCT20220509054797N1 IRCT 2022-09-24 Hamedan University of Medical Sciences The impact of music on patients undergoing myocardial perfusion imaging The impact of music on patients undergoing myocardial perfusion imaging 2022-09-23 anticipated 60 Complete https://irct.ir/trial/63435 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Myocardial perfusion scan. Intervention 1: 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). Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Information can be shared When: After announcing the results To whom: Everyone Conditions: Provided that the source of the information is mentioned Where to obtain: Research team How to obtain: After the decision of the research team after the announcement to the team Comments:
public Maryam Alvamdi
Shahid Fahmideh Blvd
Hamedan Iran (Islamic Republic of) ۶۵۱۷۸۳۸۷۳۶ +98 81 3131 0000 maryamalvandi@yahoo.com Hamedan University of Medical Sciences scientific Maryam Alvamdi
Shahid Fahmideh Blvd
Hamedan Iran (Islamic Republic of) ۶۵۱۷۸۳۸۷۳۶ +98 81 3131 0000 maryamalvandi@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age between 25 and 79 years Referrals to the nuclear medicine department of Farshchian Hospital in Hamadan Candidate patients undergo myocardial perfusion scan 25 years 79 years Both Having hearing problems Inability to read and write Having mental disorders and diseases ** ** Other N/A 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). 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. Severity of phobia. Timepoint: Before and after the intervention. Method of measurement: questionnaire. Stress. Timepoint: Measurements at the beginning and end of the test. Method of measurement: questionnaire. Anxiety. Timepoint: Measurements at the beginning and end of the test. Method of measurement: questionnaire. Exercise Test Distance. Timepoint: during exercise test. Method of measurement: exercise test information. Heart Rate. Timepoint: during exercise test. Method of measurement: exercise test information. Chronotropic Index. Timepoint: during exercise test. Method of measurement: Mathematical calculations and formulas. Heart Rate Recovery Index. Timepoint: Before and after the intervention. Method of measurement: Mathematical calculations and formulas. Reduce patient movement. Timepoint: Before and after the intervention. Method of measurement: Expert doctor's opinion. Reduce shooting frequency. Timepoint: Before and after the intervention. Method of measurement: Expert doctor's opinion. Blood pressure. Timepoint: Before and after the intervention. Method of measurement: Barometer. Overall feeling of satisfaction. Timepoint: Before and after the intervention. Method of measurement: questionnaire. Non-cardiac side effects of dipyridamole. Timepoint: Before and after the intervention. Method of measurement: questinnaire. 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. Double product. Timepoint: Before and after the intervention. Method of measurement: Mathematical calculations and formulas. Hamedan University of Medical Sciences Approved 2022-03-05 Ethics committee of hamedan university of medical sciences Shahid Fahmideh Blvd Hamedan Hamadan Iran (Islamic Republic of)