History
# Registration date Revision Id
2 2018-07-23, 1397/05/01 59319
1 2015-12-24, 1394/10/03 7183
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  • Protocol summary

    Objectives: determine the effect of fentanyl - midazolam on pain and anxiety of patients treated with ESWL; determine the effect of keterolac- midazolam on pain and anxiety of patients treated with ESWL; determine the effect of Fentanyl - music therapy on pain and anxiety of patients treated with ESWL; compare the effects of Fentanyl - music therapy, keterolac- midazolam and fentanyl - midazolam on pain and anxiety in patients treated with ESWL Design: All patients with urinary stones between 18 and 60 years old referred for ESWL were enrolled to study. Randomization based on ABC blocks and sample size determine with pilot study (10 patients in each group) and patients were placed in groups A: Fentanyl music therapy, B: Keterolac- midazolam, C: Fentanyl- Midazolam. In all three groups, prior to ESWL, anxiety measured by visual analog scale and hemodynamic parameters will be recorded. In Group A: 1μg / kg intravenous fentanyl will be injected and starts the music player with headphones. Group B: ketorolac 30 mg and midazolam 1mg; in Group C: Fentanyl μg / kg and Midazolam 1 mg will be injected and headphones off placed on the patient's head. 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 dose will be repeated and patient is excluded.
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    اهداف:تعيين اثر فنتانيل – ميدازولام بر درد و اضطراب بيماران تحت درمان باESWL؛تعيين اثر كتورولاك– ميدازولام بر درد و اضطراب بيماران تحت درمان باESWL ؛تعيين اثر فنتانیل - موسيقي درماني بر دردو اضطراب بيماران تحت درمان باESWL؛ مقايسه اثر فنتانیل - موسيقي درماني، كتورولاك– ميدازولام و فنتانيل – ميدازولام بر درد و اضطراب در بيماران تحت درمان با ESWL طراحی: کلیه مبتلایان به سنگهای ادراری بین 18 تا 60 سال مراجعه کننده جهت ESWL وارد مطالعه میشوند. تصادفی سازی با یلوکهای ABC وحجم نمونه بامطالعه راهنما(10 بيمار در هر گروه) تعيين و.بیماران در سه گروه A: فنتانیل- موسيقي درماني، B: كتورولاك- ميدازولام، C: فنتانيل- ميدازولام قرار می گیرند.در هر سه گروه اضطراب قبل از شروع سنگ شکنی با ابزار دیداری اضطراب و معیارهای همودینامیک اندازه گیری میشود. در گروه A : g/kgµ 1 فنتانيل وريدي تزريق و با هدفون پخش موسیقی آغاز می شود. درگروه B: mg 30 كتورولاك و mg 1 ميدازولام؛ در گروه C: فنتانيل g/kgµ 1وmg 1 ميدازولام وريدي تزريق و هدفون خاموش روي سر بيمار قرار مي گيرد. در تمامي بيماران درد با مقياس درجه بندي عددي پس از شروع سنگ شكني هر 10 دقيقه و در پایان پروسیجر ثبت مي شود. معیارهای هودینامیک در ابتدا؛ سپس هر 10 دقيقه و در پایان پروسیجر ثبت و اضطراب مجددا در پايان سنگ شكني ثبت مي شود. طی سنگ شکنی هر زمان بیمار بی قرار شد یا در بررسی درد نمره بالای 7 گرفت، با تایید پزشک متخصص بیهوشی دوز دارو مجدد تکرار شده و بیمار از مطالعه خارج میشود.
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    Impact of music therapy on pain and anxiety of patient undergoing Extracorporeal Shock Wave Lithotripsy
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    تعیین اثر موسيقي درماني بر درد و اضطراب بيماران تحت درمان با سنگ شكني برون اندامي
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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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    کارآزمایی بالینی تصادفی شده دارای گروه کنترل، نمونه گیری در دسترس، یک سو کور، حجم نمونه بر اساس مطالعه راهنما
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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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    محل انجام: واحد سنگ شكنی برون اندامي، بيمارستان امام علي(ع) بجنورد کلیه مبتلایان به سنگهای ادراری بین 18 تا 60 سال مراجعه کننده جهت ESWL وارد مطالعه میشوند. تصادفی سازی با بلوکهای AB وحجم نمونه بامطالعه راهنما(10 بيمار در هر گروه) تعيين خواهد شد. بیماران در دو گروه A: موسيقي درماني، B:کنترل قرار می گیرند.در هر دو گروه اضطراب قبل از شروع سنگ شکنی با ابزار دیداری اضطراب اندازه گیری و معیارهای همودینامیک ثبت می شود. در گروه A هدفون در حالت پخش موسیقی روي سر بيمار قرار مي گيرد. درگروه B هدفون در حالت خاموش روي سر بيمار قرار مي گيرد. در تمامي بيماران درد با مقياس درجه بندي عددي پس از شروع سنگ شكني هر 10 دقيقه و در پایان پروسیجر ثبت مي شود. معیارهای هودینامیک در ابتدا؛ سپس هر 10 دقيقه و در پایان پروسیجر ثبت و اضطراب مجددا در پايان سنگ شكني ثبت مي شود. طی سنگ شکنی هر زمان بیمار بی قرار شد یا در بررسی درد نمره بالای 7 گرفت، با تایید پزشک متخصص بیهوشی مراقبت روتین مرکز انجام و بیمار از مطالعه خارج میشود.
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    Patient that candidate for Extra corporeal Shock Wave Lithography
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    بیماران کاندید سنگ شکنی برون اندامی
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    Music therapy
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    موسیقی درمانی
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    Pain, anxiety
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    درد، اضطراب
  • General information

    1
    2015-12-20, 1394/09/29
    2018-11-20, 1397/08/29
    2016-06-18, 1395/03/29
    2019-04-18, 1398/01/29
    impact of music therapy on anxiety and ketorolac on pain of patient undergoing Extracorporeal Shock Wave Lithotripsy
    Impact of music therapy on anxiety and pain of patient undergoing Extra corporeal Shock Wave Lithography
    تاثیر موسیقی بر اضطراب و کتورولاک بر درد بیماران حین سنگ شکنی سنگهای کلیوی
    تاثیر موسیقی بر اضطراب و درد بیماران حین سنگ شکنی سنگهای کلیوی
    Comparing the impact of fentanyl- music therapy, fentanyl- midazolam and ketorolac-midazolam on pain and anxiety of patient undergoing Extracorporeal Shock Wave Lithotripsy
    Impact of music therapy on pain and anxiety of patient undergoing Extra corporeal Shock Wave Lithography
    مقايسه اثر فنتانیل - موسيقي درماني، كتورولاك– ميدازولام و فنتانيل – ميدازولام بر درد و اضطراب در بيماران تحت درمان با سنگ شكني برون اندامي
    بررسی تاثیر موسيقي درماني، بر درد و اضطراب بيماران تحت درمان با سنگ شكني برون اندامي
    18-60 years old
    Ability for reading and writing
    Candidate for ESWL
    No history of ESWL
    سن بین 18 تا 60 سال
    سواد خواندن و نوشتن
    كانديد سنگ شكني
    عدم وجود سابقه سنگ شكني
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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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    يك سري عدد تصادفی به اندازه نصف تعداد نمونه از جدول اعداد تصادفيانتخاب شده، چنانچه عدد تصادفی بین صفر تا 4 باشد عبارت AB و اگر بین 5 تا 9 باشد، عبارت BA را کنار هم نوشته، سپس شماره بندی شده و مطابق ورود، بیماران به یکی از گروه ها اختصاص می یابند.
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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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    هدفون روی گوش شرکت کنندگان در هر دو گروه موسیقی درمانی و کنترل گذاشته می شود. فقط در گروه موسیقی درمانی از هدفون موسیقی پخش خواهد شد.
  • Health conditions studied

    #1
    urinary stones
    Urinary stones
  • Primary outcomes

    #1
    pain
    Pain
    each 10 min during and after Procedure
    Each 10 min during and after Procedure
    numeric pain rating scale
    Numeric pain rating scale
    #2
    anxiety
    Anxiety
    before and after procidure
    Before and after procedure
  • Intervention groups

    #1
    music therapy - fentanyl 1μg / kg
    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.
    1μg / kg موسیقی درمانی-فنتانیل
    موسیقی درمانی: قبل از ورود به اتاق سنگ شکنی اضطراب بیمار با ابزار دیداری اندازه گیری ، پس از انتقال بیمار روی تخت سنگ شکنی، فشار خون (سیستول و دیاستول و متوسط فشار خون شریانی) ، سرعت ضربان قلب و تنفس، اشباع اکسیژن خون شریانی اندازه گیری و ثبت می شود. بیمار بسته به محل قرار گیری سنگ ادراری وضعیت داده می شوند. با کنترل سونوگرافی فوکوس دستگاه روی سنگ تنظیم می شود. قبل از شروع پروسیجر، هدفون روي سر بيمار قرار گرفته و پخش موسیقی آغاز می شود. طی سنگ شکنی هر زمان بیمار بی قرار شد یا در بررسی درد نمره بالای 7 گرفت، مراقبت روتین مرکز اجرا خواهد شد. در این صورت بیمار از مطالعه خارج خواهد شد. درد با مقياس درجه بندي عددي پس از شروع سنگ شكني هر 10 دقيقه و در پایان پروسیجر اندازه گيري و ثبت مي شود. فشار متوسط شرياني، تعداد ضربان قلب و تعداد تنفس در دقيقه و درصد اشباع اكسيژن خون شرياني در ابتدا و سپس هر 10 دقيقه و در پایان پروسیجركنترل و ثبت مي شود. اضطراب مجددا در پايان سنگ شكني اندازه گيري و ثبت مي شود. اندازه گیری اضطراب و درد بیماران توسط کارشناس رادیولوژی مرکز، اندازه گیری خواهد شد.کل زمان سنگ شكنی، شدت و تعداد شوك، دوز کلی داروی ضد درد و ضد اضطراب دریافت شده، طول مدت بستری بیمار در ریکاوری براي هر بيمار ثبت مي شود.
    #2
    Treatment - Drugs
    Treatment - Other
    ketorolac 30 mg - midazolam 1 mg
    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.
    کترولاک 30 میلی گرم - میدازولام 1 میلی گرم
    گروه کنترل: قبل از ورود به اتاق سنگ شکنی اضطراب بیمار با ابزار دیداری اندازه گیری و با انتقال بیمار روی تخت سنگ شکنی و اتصال به مانیتورینگ، فشار خون (سیستول و دیاستول و متوسط فشار خون شریانی) ، سرعت ضربان قلب و تنفس، اشباع اکسیژن خون شریانی اندازه گیری و ثبت می شود .بیمار بسته به محل قرار گیری سنگ ادراری وضعیت داده می شوند. با کنترل سونوگرافی فوکوس دستگاه روی سنگ تنظیم می شود. قبل از شروع پروسیجر در گروه کنترل به منظور پوشانده ماندن مداخله، هدفون بدون پخش موسيقي روي سر بيمار قرار مي گيرد. طی سنگ شکنی هر زمان بیمار بی قرار شد یا در بررسی درد نمره بالای 7 گرفت، مراقبت روتین مرکز انجام خواهد شد.درد با مقياس درجه بندي عددي پس از شروع سنگ شكني هر 10 دقيقه و در پایان پروسیجر اندازه گيري و ثبت مي شود. فشار متوسط شرياني، تعداد ضربان قلب و تعداد تنفس در دقيقه و درصد اشباع اكسيژن خون شرياني در ابتدا و سپس هر 10 دقيقه و در پایان پروسیجركنترل و ثبت مي شود. اضطراب مجددا در پايان سنگ شكني اندازه گيري و ثبت مي شود. اندازه گیری اضطراب و درد بیماران توسط کارشناس رادیولوژی مرکز، اندازه گیری خواهد شد.کل زمان سنگ شكنی، شدت و تعداد شوك، دوز کلی داروی ضد درد و ضد اضطراب دریافت شده، طول مدت بستری بیمار در ریکاوری براي هر بيمار ثبت مي شود.
    #3
    Treatment - Drugs
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    fentanyl 1μg / kg - midazolam 1mg
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    فنتانیل 1 میکروگرم به ازا هر کیلو وزن بدن - میدازولام 1 میلی گرم
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  • Recruitment centers

    #1
    Name of recruitment center - English: Imam Ali Hospital. ESWL center
    Name of recruitment center - Persian: مرکز سنگ شکنی برون اندامی بیمارستان امام علی
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Street address - English:
    Street address - Persian:
    City - English: Bojnourd
    City - Persian: بجنورد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Imam Ali Hospital. ESWL center
    Name of recruitment center - Persian: مرکز سنگ شکنی برون اندامی بیمارستان امام علی
    Full name of responsible person - English: Tooba Hoseini Azizi
    Full name of responsible person - Persian: طوبا حسینی عزیزی
    Street address - English: Shahryar
    Street address - Persian: شهریار
    City - English: Bojnourd
    City - Persian: بجنورد
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9414635665
    Phone: +98 58 3225 0358
    Fax:
    Email: hoseini.tooba@gmail.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: North Khorasan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی خراسان شمالی
    Full name of responsible person - English: Dr Alireza Golshan
    Full name of responsible person - Persian: دکتر علیرضا گلشن
    Street address - English: Shahid Sohaghar ave. no 36
    Street address - Persian: خیابان شهید محقر پلاک 36
    City - English: bojnourd
    City - Persian: بجنورد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Hojat
    Full name of responsible person - Persian: دکتر حجت
    Street address - English: Shahid Mohaghar ave. no 36
    Street address - Persian: خیابان شهید محقر پلاک 36
    City - English: bojnourd
    City - Persian: بجنورد
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9414635665
    Phone: +98 58 3468 4670
    Fax:
    Email: research@nkums.ac.ir
    Web page address:
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    Public
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    Domestic
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    Academic
    North Khorasan University of Medical Sciences
    Bojnourd University of Medical Sciences
    دانشگاه علوم پزشکی خراسان شمالی
    دانشگاه علوم پزشکی بجنورد
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: North Khorasan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی خراسان شمالی
    Full name of responsible person - English: Tooba Hoseini Azizi
    Full name of responsible person - Persian: طوبا حسینی عزیزی
    Position - English: Faculty member
    Position - Persian: عضو هیات علمی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Nursing, Shahyar Boulevard
    Street address - Persian: بلوار شهریار، دانشکده پرستاری
    City - English: Bojnourd
    City - Persian: بجنورد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 58 3225 0358
    Mobile: +91 51840177
    Fax:
    Email: hoseini.tooba@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: North Khorasan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی خراسان شمالی
    Full name of responsible person - English: Tooba Hoseini Azizi
    Full name of responsible person - Persian: طوبا حسینی عزیزی
    Position - English: Faculty member
    Position - Persian: عضو هیات علمی
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Nursing, Shahyar Boulevard
    Street address - Persian: بلوار شهریار، دانشکده پرستاری
    City - English: Bojnourd
    City - Persian: بجنورد
    Province: North Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9414635665
    Phone: +98 58 3225 0358
    Mobile: +98 915 184 0177
    Fax:
    Email: hoseini.tooba@gmail.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: North Khorasan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی
    Full name of responsible person - English: Tooba Hoseini Azizi
    Full name of responsible person - Persian: طویا حسینی عزیزی
    Position - English: MSc
    Position - Persian: کارشناس ارشد
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Nursing, Shahyar Boulevard
    Street address - Persian: بلوار شهریار، دانشکده پرستاری
    City - English: Bojnourd
    City - Persian: بجنورد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 58 3225 0358
    Mobile: +91 51840177
    Fax:
    Email: hoseini.tooba@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Tooba Hoseini Azizi
    Full name of responsible person - Persian: طویا حسینی عزیزی
    Position - English: MSc
    Position - Persian: کارشناس ارشد
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Nursing, Shahyar Boulevard
    Street address - Persian: بلوار شهریار، دانشکده پرستاری
    City - English: Bojnourd
    City - Persian: بجنورد
    Province: North Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9414635665
    Phone: +98 58 3225 0358
    Mobile: +98 915 184 0177
    Fax:
    Email: hoseini.tooba@gmail.com
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Position - English:
    Position - Persian:
    Latest degree:
    Area of specialty/work:
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available:
    Country:
    Postal code:
    Phone:
    Mobile:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Tooba Hoseini Azizi
    Full name of responsible person - Persian: طوبا حسینی عزیزی
    Position - English: Faculty member
    Position - Persian: مربی هیات علمی
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahryar
    Street address - Persian: شهریار
    City - English: Bojnourd
    City - Persian: بجنورد
    Province: North Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9414635665
    Phone: +98 58 3225 0358
    Mobile: +98 915 184 0177
    Fax:
    Email: hoseini.tooba@gmail.com
    Web page address:
  • Sharing plan

    undecided
    undecided
    na
    undecided
    undecided
    na
    na
    empty
    There is no more information.
    empty
    اطلاعات بیشتری وجود ندارد.

Protocol summary

Study aim
Impact of music therapy on pain and anxiety of patient undergoing Extracorporeal Shock Wave Lithotripsy
Design
Randomized clinical trial with a control group, convenience sampling, one-way blind, sample size base on pilot study.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Patient that candidate for Extra corporeal Shock Wave Lithography
Intervention groups
Music therapy
Main outcome variables
Pain, anxiety

General information

Reason for update
Acronym
IRCT registration information
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
Registration date
2015-12-24, 1394/10/03
Registrant information
Name
Tooba Hoseini Azizi
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 58 3225 0358
Email address
hoseiniat881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
North Khorasan University of Medical Sciences
Expected recruitment start date
2018-11-20, 1397/08/29
Expected recruitment end date
2019-04-18, 1398/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of music therapy on pain and anxiety of patient undergoing Extra corporeal Shock Wave Lithography
Public title
Impact of music therapy on anxiety and pain of patient undergoing Extra corporeal Shock Wave Lithography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
18-60 years old Ability for reading and writing Candidate for ESWL No history of ESWL
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
North Khorasan University of Medical Sciences
Street address
North Khorasan
City
Bojnourd
Province
North Khorasan
Postal code
9414635665
Approval date
2015-10-05, 1394/07/13
Ethics committee reference number
ir.nkums.rec.1394.34

Health conditions studied

1

Description of health condition studied
Urinary stones
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter

Primary outcomes

1

Description
Pain
Timepoint
Each 10 min during and after Procedure
Method of measurement
Numeric pain rating scale

2

Description
Anxiety
Timepoint
Before and after procedure
Method of measurement
Anxiety numerical visual analogue scale

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Other

2

Description
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.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital. ESWL center
Full name of responsible person
Tooba Hoseini Azizi
Street address
Shahryar
City
Bojnourd
Province
North Khorasan
Postal code
9414635665
Phone
+98 58 3225 0358
Email
hoseini.tooba@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr Hojat
Street address
Shahid Mohaghar ave. no 36
City
bojnourd
Province
North Khorasan
Postal code
9414635665
Phone
+98 58 3468 4670
Email
research@nkums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
North Khorasan University of Medical Sciences
Full name of responsible person
Tooba Hoseini Azizi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Shahyar Boulevard
City
Bojnourd
Province
North Khorasan
Postal code
9414635665
Phone
+98 58 3225 0358
Fax
Email
hoseini.tooba@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Tooba Hoseini Azizi
Position
MSc
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Shahyar Boulevard
City
Bojnourd
Province
North Khorasan
Postal code
9414635665
Phone
+98 58 3225 0358
Fax
Email
hoseini.tooba@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Tooba Hoseini Azizi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahryar
City
Bojnourd
Province
North Khorasan
Postal code
9414635665
Phone
+98 58 3225 0358
Email
hoseini.tooba@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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