Protocol summary
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Study aim
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Impact of music therapy on pain and anxiety of patient undergoing Extracorporeal Shock Wave Lithotripsy
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Design
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Randomized clinical trial with a control group, convenience sampling, one-way blind, sample size base on pilot study.
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Settings and conduct
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Place: ESWL unit, Imam Ali Hospital in Bojnourd
All patients with urinary stones between 18 and 60 years old referred for ESWL were enrolled to study.
Randomization-based on AB blocks and sample size determination with a pilot study (10 patients in each group)
patients have placed in groups A (music therapy), B (control). In all two groups, prior to ESWL, anxiety measured by the visual analog scale and hemodynamic parameters will be recorded.
In Group A: headphones are placed on the patient's head in play mode .
Group B: headphones are placed on the patient's head in silent mode.
In all cases, the pain will be measured by numerical rating scale every 10 minutes and after the lithotripsy procedure. Hemodynamic parameters will be recorded initially and then every 10 minutes and at the end of the procedure and anxiety will be recorded at the end of lithotripsy. If the patient was restless during lithotripsy any time or pain score was above 7, with the approval of anesthesiologist, the routine care of the center is performed and the patient is excluded.
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Participants/Inclusion and exclusion criteria
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Patient that candidate for Extra corporeal Shock Wave Lithography
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Intervention groups
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Music therapy
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Main outcome variables
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Pain, anxiety
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201511026776N2
Registration date:
2015-12-24, 1394/10/03
Registration timing:
prospective
Last update:
2018-09-12, 1397/06/21
Update count:
1
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Registration date
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2015-12-24, 1394/10/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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North Khorasan University of Medical Sciences
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Expected recruitment start date
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2018-11-20, 1397/08/29
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Expected recruitment end date
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2019-04-18, 1398/01/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Impact of music therapy on pain and anxiety of patient undergoing Extra corporeal Shock Wave Lithography
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Public title
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Impact of music therapy on anxiety and pain of patient undergoing Extra corporeal Shock Wave Lithography
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
18-60 years old
Ability for reading and writing
Candidate for ESWL
No history of ESWL
Exclusion criteria:
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Headphone put on the ears of Participants in both music therapy and control groups. Music will only be played in music therapy groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-10-05, 1394/07/13
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Ethics committee reference number
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ir.nkums.rec.1394.34
Health conditions studied
1
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Description of health condition studied
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Urinary stones
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ICD-10 code
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N20
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ICD-10 code description
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Calculus of kidney and ureter
Primary outcomes
1
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Description
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Pain
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Timepoint
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Each 10 min during and after Procedure
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Method of measurement
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Numeric pain rating scale
2
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Description
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Anxiety
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Timepoint
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Before and after procedure
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Method of measurement
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Anxiety numerical visual analogue scale
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Bojnourd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable