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IRCT201511026776N2 IRCT 2015-12-24 Bojnourd University of Medical Sciences Impact of music therapy on anxiety and pain of patient undergoing Extra corporeal Shock Wave Lithography Impact of music therapy on pain and anxiety of patient undergoing Extra corporeal Shock Wave Lithography 2018-11-20 anticipated 90 Complete https://irct.ir/trial/7183 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Series of the random number equal to the half number of samples will be selected from a random numbers table. If the random number will between 0 and 4, phrase AB and if between 5 and 9, phrase BA will be written next to each other, then numbered and, according to the entry, the patients will be assigned into one of groups, Blinding description: Headphone put on the ears of Participants in both music therapy and control groups. Music will only be played in music therapy groups. N/A Urinary stones. Intervention 1: Music therapy: Before entering the ESWL room, the patient's anxiety will measured by the visual analog scale, after transfer the patient on ESWL bed, blood pressure (systole and diastole and mean arterial blood pressure), heart rate and respiration rate, arterial oxygen saturation measured and recorded. The patient will given a position depending on the location of the urinary stones. By controlling with ultrasound, the focus of the device is adjusted to the stone. Before the procedure begins, the headphones are placed on the patient's head and the music starts playing. During the ESWL process, whenever the patient becomes restless or in the examination of a pain score of more than 7, the routine care of the center will be performed. In this case, the patient will be excluded from the study. With the start of the procedure, the pain is measured every 10 minutes and at the end of the procedure with a numerical grading scale. The mean arterial pressure, heart rate and respiratory rate per minute, and arterial oxygen saturation are monitored at the beginning and then every 10 minutes at the end of the procedure. Anxiety is measured and recorded at the end of the procedure. Anxiety and pain measurement will be measured by a radiologist at the center. The total ESWL time, severity and number of shock, the total dose of the analgesic and anti-anxiety medication received, the length of the patient's stay in recovery will be recorded for each patient. Intervention 2: Control group: Music therapy: Before entering the ESWL room, the patient's anxiety will measured by the visual analog scale, after transfer the patient on ESWL bed, blood pressure (systole and diastole and mean arterial blood pressure), heart rate and respiration rate, arterial oxygen saturation measured and recorded. The patient will given a position depending on the location of the urinary stones. By controlling with ultrasound, the focus of the device is adjusted to the stone.Before starting the procedure to cover the intervention, headphones are placed on the patient's head without music playing. During the ESWL process, whenever the patient becomes restless or in the examination of a pain score of more than 7, the routine care of the center will be performed. With the start of the procedure, the pain is measured every 10 minutes and at the end of the procedure with a numerical grading scale. The mean arterial pressure, heart rate and respiratory rate per minute, and arterial oxygen saturation are monitored at the beginning and then every 10 minutes at the end of the procedure. Anxiety is measured and recorded at the end of the procedure. Anxiety and pain measurement will be measured by a radiologist at the center. The total ESWL time, severity and number of shock, the total dose of the analgesic and anti-anxiety medication received, the length of the patient's stay in recovery will be recorded for each patient. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Tooba Hoseini Azizi
Faculty of Nursing, Shahyar Boulevard
Bojnourd Iran (Islamic Republic of) 9414635665 +98 58 3225 0358 hoseini.tooba@gmail.com North Khorasan University of Medical Sciences scientific Tooba Hoseini Azizi
Faculty of Nursing, Shahyar Boulevard
Bojnourd Iran (Islamic Republic of) 9414635665 +98 58 3225 0358 hoseini.tooba@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) 18-60 years old Ability for reading and writing Candidate for ESWL No history of ESWL 18 years 60 years Both N20 Calculus of kidney and ureter Treatment - Other Treatment - Other Music therapy: Before entering the ESWL room, the patient's anxiety will measured by the visual analog scale, after transfer the patient on ESWL bed, blood pressure (systole and diastole and mean arterial blood pressure), heart rate and respiration rate, arterial oxygen saturation measured and recorded. The patient will given a position depending on the location of the urinary stones. By controlling with ultrasound, the focus of the device is adjusted to the stone. Before the procedure begins, the headphones are placed on the patient's head and the music starts playing. During the ESWL process, whenever the patient becomes restless or in the examination of a pain score of more than 7, the routine care of the center will be performed. In this case, the patient will be excluded from the study. With the start of the procedure, the pain is measured every 10 minutes and at the end of the procedure with a numerical grading scale. The mean arterial pressure, heart rate and respiratory rate per minute, and arterial oxygen saturation are monitored at the beginning and then every 10 minutes at the end of the procedure. Anxiety is measured and recorded at the end of the procedure. Anxiety and pain measurement will be measured by a radiologist at the center. The total ESWL time, severity and number of shock, the total dose of the analgesic and anti-anxiety medication received, the length of the patient's stay in recovery will be recorded for each patient. Control group: Music therapy: Before entering the ESWL room, the patient's anxiety will measured by the visual analog scale, after transfer the patient on ESWL bed, blood pressure (systole and diastole and mean arterial blood pressure), heart rate and respiration rate, arterial oxygen saturation measured and recorded. The patient will given a position depending on the location of the urinary stones. By controlling with ultrasound, the focus of the device is adjusted to the stone.Before starting the procedure to cover the intervention, headphones are placed on the patient's head without music playing. During the ESWL process, whenever the patient becomes restless or in the examination of a pain score of more than 7, the routine care of the center will be performed. With the start of the procedure, the pain is measured every 10 minutes and at the end of the procedure with a numerical grading scale. The mean arterial pressure, heart rate and respiratory rate per minute, and arterial oxygen saturation are monitored at the beginning and then every 10 minutes at the end of the procedure. Anxiety is measured and recorded at the end of the procedure. Anxiety and pain measurement will be measured by a radiologist at the center. The total ESWL time, severity and number of shock, the total dose of the analgesic and anti-anxiety medication received, the length of the patient's stay in recovery will be recorded for each patient. Pain. Timepoint: Each 10 min during and after Procedure. Method of measurement: Numeric pain rating scale. Anxiety. Timepoint: Before and after procedure. Method of measurement: Anxiety numerical visual analogue scale. Bojnourd University of Medical Sciences Approved 2015-10-05 North Khorasan University of Medical Sciences North Khorasan Bojnourd North Khorasan Iran (Islamic Republic of)