History
# Registration date Revision Id
2 2018-12-21, 1397/09/30 72062
1 2016-11-04, 1395/08/14 5065
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  • Protocol summary

    Objective: To determine the effect of aromatherapy with essential oils of lavender and peppermint on the sleep quality of cardiac patients Design: randomized controlled clinical trials Setting and conduct: sample size is 90 patients. Eligible patients will select by convenience sampling and randomly assign in intervention(groups 1 and 2) and control groups. Inclusion and exclusion criteria: inclusion criteria include Consent to participate in the study, positive reaction to smell, earn points equal to or more than five from the Pittsburgh sleep quality Index. Exclusion criteria include Unwillingness to continue to cooperate, and administering oxygen for patients. Interventions: Initially the quality of sleep questionnaire will be completed by patients. The study will perform for three consecutive nights, at bedtime. In groups one and two, of essential oil of lavender and mint will be used respectively and in group three sterile water will use. The essential oils will be spilled on the patient's cloth and will be attached to the patient's clothing for 20 minutes. On the morning of the fourth day, Pittsburgh Sleep Quality Index will be completed again by the patients. The main outcome variables: quality of sleep
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    هدف: تعیین و مقایسه میزان تاثیر رایحه‌درمانی با اسانس‌های اسطوخدوس و نعناع بر کیفیت خواب بیماران قلبی طراحی: کارآزمایی بالینی شاهددار تصادفی نحوه انجام: حجم نمونه 90 نفر است. بیماران واجد شرایط، به روش در دسترس انتخاب شده و به روش تصادفی در گروه ‌های مداخله(گروه های 1 و 2) و کنترل قرار میگیرند. معیارهای ورود و خروج: معیارهای ورود شامل رضایت جهت شرکت در مطالعه، تست بویایی مثبت، و کسب امتیاز مساوی یا بیش از پنج از پرسشنامه کیفیت خواب پیتزبورگ، می باشد. معیارهای خروج شامل عدم تمایل به ادامه همکاری، و تجویز اکسیژن برای بیمار می باشد مداخلات: در ابتدا ﭘﺮﺳشنامه ﻛﻴﻔﻴﺖ ﺧﻮﺍﺏ توسط نمونه‌ها تکمیل میشود. مطالعه به مدت سه شب متوالی، قبل از خواب انجام میگردد. در گروه یک و دو به ترتیب از ﺍﺳــﺎﻧﺲ ﺍﺳﻄﻮﺧﻮﺩﻭﺱ و نعناع استفاده میشود و در گروه سه از آب مقطر، استفاده میشود. قطره ها بر ﺭﻭﻱ ﺩﺳﺘﻤﺎﻝ ﭼﻜﺎﻧﺪﻩ شده و به مدت20 ﺩﻗﻴﻘﻪ ﺑﻪ ﻟﺒـﺎﺱ ﺑﻴﻤـﺎﺭ ﻣﺘﺼﻞ خواهد شد. در ﺻـﺒﺢ روز چهارم، ﭘﺮﺳـــشنامه ﻛﻴﻔﻴﺖ ﺧﻮﺍﺏ ﭘﻴﺘﺰﺑوﺮگ، مجددا توسط نمونه ها تکمیل خواهد شد. متغیر پیامد اصلی: کیفیت خواب
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    To determine the effect of aromatherapy with essential oils of lavender and peppermint on the sleep quality of cardiac patients
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    تعیین و مقایسه میزان تاثیر رایحه‌درمانی با اسانس‌های اسطوخدوس و نعناع بر کیفیت خواب بیماران قلبی
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    Clinical trials, with parallel groups, randomized
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    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، کور سازی ندارد و تصادفی شده است
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    In this study, heart patients hospitalized in Imam Ali Hospital and eligible individuals were randomly divided into three groups (two intervention groups and one control group). For 7 nights at 22 o'clock, in group one, three drops of peppermint essential oil, in group two, three drops of lavender essential oil, and in group three (control group), three drops of distilled water, on a napkin, and held for 20 minutes by the gauze , Will be attached in the chest area.
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    در این مطالعه بیماران قلبی بستری در بیمارستان امام علی(ع) و واجد شرایط، به طور تصادفی به سه گروه(دو گروه مداخله و یک گروه کنترل) تقسیم خواهندشد. به مدت هفت شب در ساعت 22، درگروه یک، سه ﻗﻄــﺮﻩ ﺍﺳــﺎﻧﺲ نعناع ، در گروه دو، ﺳﻪ ﻗﻄﺮه اﺳﺎﻧﺲﺍسطوخودوس و در گروه سه(گروه کنترل)، سه قطره آب مقطر، ﺑﺮ ﺭﻭﻱ ﺩﺳﺘﻤﺎﻝ ﭼﻜﺎﻧﺪﻩ شده و به مدت 20 ﺩﻗﻴﻘﻪ توسط ﮔﻴﺮﻩ، ﺑﻪ ﻟﺒـﺎﺱ ﺑﻴﻤـﺎﺭ ﺩﺭ ﻧﺎﺣﻴه ﺳﻴﻨﻪ ﻣﺘﺼﻞ خواهد شد.
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    inclusion criteria include Consent to participate in the study, positive reaction to smell, earn points equal to or more than five from the Pittsburgh sleep quality Index. Exclusion criteria include Unwillingness to continue to cooperate, and administering oxygen for patients.
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    معیارهای ورود شامل رضایت جهت شرکت در مطالعه، تست بویایی مثبت، و کسب امتیاز مساوی یا بیش از پنج از پرسشنامه کیفیت خواب پیتزبورگ، می باشد. معیارهای خروج شامل عدم تمایل به ادامه همکاری، و تجویز اکسیژن برای بیمار می باشد
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    In group1,for seven nights at 22 o'clock,the three drops of Peppermint essential oil will be used.Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for20minutes. In group2:for seven nights at 22 o'clock, the three drops of lavender essential oil will be used. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for 20 minutes In control group: for seven nights at 22 o'clock, the three drops of distilled water and is connected to the patient's clothing at the chest and inhaled for20 minutes
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    در گروه یک، به مدت هفت شب در ساعت 22، از ﺳﻪ ﻗﻄﺮه اﺳﺎﻧﺲ نعناع فلفلی استفاده میشود. اسانس توسط قطره چکان ﺭﻭﻱ ﺩﺳﺘﻤﺎﻝ ﭼﻜﺎﻧﺪﻩ شده و به ﻟﺒـﺎﺱ ﺑﻴﻤـﺎﺭ در ناحیه سینه ﻣﺘﺼﻞ میگردد و به مدت20 ﺩﻗﻴﻘﻪ استنشاق میشود. مداخله دو: در گروه دو به مدت هفت شب در ساعت 22، سه ﻗﻄــﺮﻩ ﺍﺳــﺎﻧﺲ ﺍﺳﻄﻮﺧﺩﻭﺱتوسط قطره چکان ﺭﻭﻱ ﺩﺳﺘﻤﺎﻝ ﭼﻜﺎﻧﺪﻩ شده و به مدت20 ﺩﻗﻴﻘﻪ به وسیله ﮔﻴﺮﻩ، ﺑﻪ ﻟﺒـﺎﺱ ﺑﻴﻤـﺎﺭ در ناحیه سینه ﻣﺘﺼﻞ و به شیوه ی استنشاقی از آن استفاده خواهد شد. مداخله سه: در گروه سه( گروه کنترل)، به مدت هفت شب در ساعت 22، سه قطره آب مقطر ﺭﻭﻱ ﺩﺳﺘﻤﺎﻝ ﭼﻜﺎﻧﺪﻩ شده و به مدت20 ﺩﻗﻴﻘﻪ به وسیله ی ﮔﻴﺮﻩ، ﺑﻪ ﻟﺒـﺎﺱ ﺑﻴﻤـﺎﺭ در ناحیه سینه ﻣﺘﺼﻞ خواهد شد.
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    sleep quality
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    کیفیت خواب
  • General information

    2
    2-3
    90
    105
    Consent to participate in the stud
    positive reaction to smell
    he stability of vital signs (blood pressure, pulse, respiration and temperature)
    having aged 18 to 65 years
    earn points equal to or more than five from the Pittsburgh sleep quality Index
    Lack of sinusitis and Pneumonia
    no addiction to drugs and alcohol
    Being alert
    Passed 48 hours of admission
    not having mental disease and no history of hospitalization in psychiatric wards
    Do not take caffeine one hour before bedtime
    رضایت جهت شرکت در مطالعه
    تست بویایی مثبت
    پایداری علائم حیاتی (فشارخون، نبض، تنفس و درجه حرارت)
    دارا بودن سن 18 تا 65 سال
    کسب امتیاز مساوی یا بیش از پنج از پرسشنامه کیفیت خواب پیتزبورگ
    عدم ابتلا به سینوزیت و پنومونی
    عدم مصرف سیگار، مواد مخدر و الکل
    برخورداری از هوشیاری‌‌‌کامل
    ‌‌‌‌گذشت‌‌‌‌48ساعت ‌‌‌‌از بستری‌‌‌‌شدن
    نداشتن سابقه بیماری اعصاب‌‌‌‌ و‌‌‌‌ روان و سابقه بستری در بخش روان؛
    عدم مصرف نوشیدنی‌های کافیین‌دار از یک ساعت قبل از خواب
    Unwillingness to continue to cooperate
    Transition to other wards or death
    Receiving narcotic and oxygen during aromatherapy
    critically ill patient during the study
    عدم تمایل به ادامه همکاری
    انتقال به بخش دیگر
    دریافت اکسیژن و داروی مخدر در هنگام رایحه‌درمانی
    بدحال شدن بیمار در طول مطالعه
    The samples will be placed in one of the intervention and control groups by using a lottery
    نمونه ها با استفاده از قرعه کشی در یکی از گروههای مداخله و کنترل قرار خواهند گرفت.
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    Qualified samples were entered into the study by accessible method and randomly divided into intervention groups (peppermint and lavender) and control. Blocks were done as follows: To aromatic groups with peppermint essential oil and Lavender was assigned A and B codes respectively, and the control group received C code. The study blocks were ABC, ACB, BAC, BCA, CAB, CBA, BCC, CAB, CAB, and the ABC block was selected as the first block. Patients were assigned to peppermint, lavender, and control groups, respectively, and this method continued until the samples were completed.
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    نمونه های واجدشرایط به روش در دسترس وارد مطالعه شدند و به روش بلوک بندی تصادفی در گروه های مداخله(نعناع فلفلی و اسطوخدوس) و کنترل قرار گرفتند.، بلوک بندی به صورت زیر انجام شد: به گروه های رایحه درمانی با اسانس نعناع فلفلی و اسطوخدوس به ترتیب کدهای A و B اختصاص داده شد و گروه کنترل، کد C را دریافت نمود. بلوک بندی مطالعه به صورت ABC,ACB,BAC,BCA,CAB,CBA, بود که بلوکABC به عنوان اولین بلوک انتخاب شد، بیماران به ترتیب به گروه نعناع فلفلی، اسطوخدوس و کنترل تخصیص یافتند و تا تکمیل نمونه ها این روش ادامه یافت.
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  • Health conditions studied

    #1
    121
    I25.1
    Acute myocardial infarction
    Coronary Artery Disease
    cardiac disease
    Coronary Artery Disease
    بیماری قلبی
    بیماری عروق کرونر
    #2
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    I22
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    Myocardial infarction
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    Myocardial infarction
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    انفارکتوس میوکارد
    #3
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    I50.0
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    Congestive heart failure
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    Congestive heart failure
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    نارسایی احتقانی قلب
  • Primary outcomes

    #1
    at the beginning of study and fourth day
    at the beginning of study and Eighth day
    در شروع مطالعه و روز چهارم
    در شروع مطالعه و روز هشتم
  • Intervention groups

    #1
    In group I, for three nights before going to sleep at 22 o'clock, the two drops of lavender essential oil will be used. Trade name of this essence is lavender essential oil and its scientific name is Lavandula stoechas which is produced by Tehran Zarband Company. This essential oil will be used in pure form with a concentration of 100 percent. Major chemical compounds included are linalyl acetate and linalool. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for 20 minutes.
    In group I, for seven nights before going to sleep at 22 o'clock, the three drops of lavender essential oil will be used. Trade name of this essence is lavender essential oil and its scientific name is Lavandula stoechas which is produced by Tehran Zarband Company. This essential oil will be used in pure form with a concentration of 100 percent. Major chemical compounds included are linalyl acetate and linalool. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for 20 minutes.
    مداخله 1: در گروه یک، به مدت سه شب قبل از خواب در ساعت 22، ﺩﻭ ﻗﻄــﺮﻩ ﺍﺳــﺎﻧﺲ ﺍﺳﻄﻮﺧﺩﻭﺱ با نام تجاری lavender essential oil، و نام علمی Lavandula stoechas ساخت شرکت زرد بند تهران، به صورت خالص با غلظت 100 درصد ، با ترکیبات شیمیایی ماژور شامل لینالیل استات و لینالول، توسط قطره چکان ﺭﻭﻱ ﺩﺳﺘﻤﺎﻝ ﭼﻜﺎﻧﺪﻩ شده و به مدت20 ﺩﻗﻴﻘﻪ به وسیله ﮔﻴﺮﻩ، ﺑﻪ ﻟﺒـﺎﺱ ﺑﻴﻤـﺎﺭ در ناحیه سینه ﻣﺘﺼﻞ و به شیوه ی استنشاقی از آن استفاده خواهد شد
    مداخله 1: در گروه یک، به مدت هفت شب قبل از خواب در ساعت 22، سه ﻗﻄــﺮﻩ ﺍﺳــﺎﻧﺲ ﺍﺳﻄﻮﺧﺩﻭﺱ با نام تجاری lavender essential oil، و نام علمی Lavandula stoechas ساخت شرکت زرد بند تهران، به صورت خالص با غلظت 100درصد ، با ترکیبات شیمیایی ماژور شامل لینالیل استات و لینالول، توسط قطره چکان ﺭﻭﻱ ﺩﺳﺘﻤﺎﻝ ﭼﻜﺎﻧﺪﻩ شده و به مدت20 ﺩﻗﻴﻘﻪ به وسیله ﮔﻴﺮﻩ، ﺑﻪ ﻟﺒـﺎﺱ ﺑﻴﻤـﺎﺭ در ناحیه سینه ﻣﺘﺼﻞ و به شیوه ی استنشاقی از آن استفاده خواهد شد
    #2
    In group 2, for three nights before going to sleep at 22 o'clock, the three drops of Peppermint essential oil will be used. Colpermin' is a pharmaceutical brand name for peppermint oil and Its scientific name is Mentha piperita which is produced by Tehran Zarband Company. This essential oil will be used in pure form with a concentration of 100 percent. Major chemical compounds included Menthol, Mentol and methyl acetate. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for 20 minutes.
    In group 2, for seven nights before going to sleep at 22 o'clock, the three drops of Peppermint essential oil will be used. Colpermin' is a pharmaceutical brand name for peppermint oil and Its scientific name is Mentha piperita which is produced by Tehran Zarband Company. This essential oil will be used in pure form with a concentration of 100 percent. Major chemical compounds included Menthol, Mentol and methyl acetate. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for 20 minutes.
    مداخله 2: در گروه دو، به مدت سه شب قبل از خواب در ساعت 22، از ﺳﻪ ﻗﻄﺮه اﺳﺎﻧﺲ نعناع فلفلی استفاده میشود. نام تجاری این اسانس peppermint essential oil، و نام علمی آن mentha piperita است که ساخت شرکت زرد بند تهران، میباشد. این اسانس به صورت خالص با غلظت 100 درصد، به کار میرود. ترکیبات شیمیایی ماژور شامل منتول، منتون و متیل استات، هستند. اسانس توسط قطره چکان ﺭﻭﻱ ﺩﺳﺘﻤﺎﻝ ﭼﻜﺎﻧﺪﻩ شده و به ﻟﺒـﺎﺱ ﺑﻴﻤـﺎﺭ در ناحیه سینه ﻣﺘﺼﻞ میگردد و به مدت20 ﺩﻗﻴﻘﻪ استنشاق میشود.
    مداخله 2: در گروه دو، به مدت هفت شب قبل از خواب در ساعت 22، از ﺳﻪ ﻗﻄﺮه اﺳﺎﻧﺲ نعناع فلفلی استفاده میشود. نام تجاری این اسانس peppermint essential oil، و نام علمی آن mentha piperita است که ساخت شرکت زرد بند تهران، میباشد. این اسانس به صورت خالص با غلظت 100 درصد، به کار میرود. ترکیبات شیمیایی ماژور شامل منتول، منتون و متیل استات، هستند. اسانس توسط قطره چکان ﺭﻭﻱ ﺩﺳﺘﻤﺎﻝ ﭼﻜﺎﻧﺪﻩ شده و به ﻟﺒـﺎﺱ ﺑﻴﻤـﺎﺭ در ناحیه سینه ﻣﺘﺼﻞ میگردد و به مدت20 ﺩﻗﻴﻘﻪ استنشاق میشود.
    #3
    In control group, for three nights before going to sleep at 22 o'clock, the three drops of distilled water will be used which is produced by Tehran Samen Company. Distilled water will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for 20 minutes.
    In control group, for seven nights before going to sleep at 22 o'clock, the three drops of distilled water will be used which is produced by Tehran Samen Company. Distilled water will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for 20 minutes.
    در گروه گروه کنترل، به مدت سه شب قبل از خواب در ساعت 22، سه قطره آب مقطر ساخت شرکت ثامن تهران، توسط قطره چکان ﺭﻭﻱ ﺩﺳﺘﻤﺎﻝ ﭼﻜﺎﻧﺪﻩ شده و به مدت20 ﺩﻗﻴﻘﻪ به وسیله ی ﮔﻴﺮﻩ، ﺑﻪ ﻟﺒـﺎﺱ ﺑﻴﻤـﺎﺭ در ناحیه سینه ﻣﺘﺼﻞ خواهد شد.
    در گروه گروه کنترل، به مدت هفت شب قبل از خواب در ساعت 22، سه قطره آب مقطر ساخت شرکت ثامن تهران، توسط قطره چکان ﺭﻭﻱ ﺩﺳﺘﻤﺎﻝ ﭼﻜﺎﻧﺪﻩ شده و به مدت20 ﺩﻗﻴﻘﻪ به وسیله ی ﮔﻴﺮﻩ، ﺑﻪ ﻟﺒـﺎﺱ ﺑﻴﻤـﺎﺭ در ناحیه سینه ﻣﺘﺼﻞ خواهد شد.
  • Recruitment centers

    #1
    Name of recruitment center - English: Imam Ali Hospital of Kermanshah
    Name of recruitment center - Persian: بیمارستان امام علی(ع) کرمانشاه
    Full name of responsible person - English: Alireza Khatony
    Full name of responsible person - Persian: علیرضا خاتونی
    Street address - English: Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street, Kermanshah
    Street address - Persian: کرمانشاه، خیابان عشایر، دانشکده پرستاری و مامایی کرمانشاه، دپارتمان پرستاری
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Imam Ali Hospital of Kermanshah
    Name of recruitment center - Persian: بیمارستان امام علی(ع) کرمانشاه
    Full name of responsible person - English: Alireza Khatony
    Full name of responsible person - Persian: علیرضا خاتونی
    Street address - English: Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street, Kermanshah
    Street address - Persian: کرمانشاه، خیابان عشایر، دانشکده پرستاری و مامایی کرمانشاه، دپارتمان پرستاری
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Country: Iran (Islamic Republic of)
    Postal code: 6714634698
    Phone: +98 83 3827 9394
    Fax:
    Email: akhatony@gmail.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Kermanshah University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کرمانشاه
    Full name of responsible person - English: Behrooz Hamzeh
    Full name of responsible person - Persian: بهروز حمزه
    Street address - English: Vice chancellor for research, Kermanshah University of Medical Sciences, Shahid Beheshty Blv., Kermanshah, Iran
    Street address - Persian: کرمانشاه، بلوار شهید بهشتی، معاونت تحقیقات و فناوری دانشگاه علوم پزشکی کرمانشاه
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Kermanshah University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کرمانشاه
    Full name of responsible person - English: Behrooz Hamzeh
    Full name of responsible person - Persian: بهروز حمزه
    Street address - English: Vice chancellor for research, Kermanshah University of Medical Sciences, Shahid Beheshty Blv., Kermanshah, Iran
    Street address - Persian: کرمانشاه، بلوار شهید بهشتی، معاونت تحقیقات و فناوری دانشگاه علوم پزشکی کرمانشاه
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Country: Iran (Islamic Republic of)
    Postal code: 6714634698
    Phone: +98 83 3827 9394
    Fax:
    Email: akhatony@gmail.com
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Kermanshah School of Nursing and Midwifery
    Name of organization / entity - Persian: دانشکده پرستاری و مامایی
    Full name of responsible person - English: alireza khatony
    Full name of responsible person - Persian: علیرضا خاتونی
    Position - English: PhD, Faculty Member
    Position - Persian: دکترا، 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: Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
    Street address - Persian: کرمانشاه، بلوار عشایر، دانشکده پرستاری و مامایی ، دپارتمان پرستاری
    City - English: kermanshah
    City - Persian: کرمانشاه
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 83 3827 9394
    Mobile: +98 912 604 9545
    Fax:
    Email: akhatony@kums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kermanshah School of Nursing and Midwifery
    Name of organization / entity - Persian: دانشکده پرستاری و مامایی
    Full name of responsible person - English: alireza khatony
    Full name of responsible person - Persian: علیرضا خاتونی
    Position - English: PhD, Faculty Member
    Position - Persian: دکترا، عضو هیات علمی
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
    Street address - Persian: کرمانشاه، بلوار عشایر، دانشکده پرستاری و مامایی ، دپارتمان پرستاری
    City - English: kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6714634698
    Phone: +98 83 3827 9394
    Mobile: +98 912 604 9545
    Fax:
    Email: akhatony@kums.ac.ir
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Kermanshah School of Nursing and Midwifery
    Name of organization / entity - Persian: دانشکده پرستاری و مامایی
    Full name of responsible person - English: Alireza Khatony
    Full name of responsible person - Persian: علیرضا خاتونی
    Position - English: PhD in Nursing Education
    Position - Persian: دکترای آموزش پرستاری
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
    Street address - Persian: کرمانشاه، بلوار عشایر، دانشکده پرستاری و مامایی ، دپارتمان پرستاری
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 83 3827 9394
    Mobile: +98 912 604 9545
    Fax:
    Email: akhatony@kums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kermanshah School of Nursing and Midwifery
    Name of organization / entity - Persian: دانشکده پرستاری و مامایی
    Full name of responsible person - English: Alireza Khatony
    Full name of responsible person - Persian: علیرضا خاتونی
    Position - English: PhD in Nursing Education
    Position - Persian: دکترای آموزش پرستاری
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
    Street address - Persian: کرمانشاه، بلوار عشایر، دانشکده پرستاری و مامایی ، دپارتمان پرستاری
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6714634698
    Phone: +98 83 3827 9394
    Mobile: +98 912 604 9545
    Fax:
    Email: akhatony@kums.ac.ir
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Kermanshah School of Nursing and Midwifery
    Name of organization / entity - Persian: دانشکده پرستاری و مامایی
    Full name of responsible person - English: Alireza Khatony
    Full name of responsible person - Persian: علیرضا خاتونی
    Position - English: PhD in Nursing Education, Faculty member
    Position - Persian: دکترای آموزش پرستاری، 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: Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
    Street address - Persian: کرمانشاه، بلوار عشایر، دانشکده پرستاری و مامایی ، دپارتمان پرستاری
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 83 3827 9394
    Mobile: +98 912 604 9545
    Fax:
    Email: akhatony@kums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kermanshah School of Nursing and Midwifery
    Name of organization / entity - Persian: دانشکده پرستاری و مامایی
    Full name of responsible person - English: Alireza Khatony
    Full name of responsible person - Persian: علیرضا خاتونی
    Position - English: PhD in Nursing Education, Faculty member
    Position - Persian: دکترای آموزش پرستاری، عضو هیات علمی
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
    Street address - Persian: کرمانشاه، بلوار عشایر، دانشکده پرستاری و مامایی ، دپارتمان پرستاری
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6714634698
    Phone: +98 83 3827 9394
    Mobile: +98 912 604 9545
    Fax:
    Email: akhatony@kums.ac.ir
    Web page address:
  • Sharing plan

    yes
    yes
    na
    undecided
    yes
    yes
    no
    empty
    The main consequence is the possibility of sharing information.
    empty
    اطلاعات مربوط به پیامد اصلی امکان اشتراک گذاری دارد.
    empty
    Six months after the publication of the article
    empty
    6 ماه پس از چاپ مقاله
    empty
    Researchers working in academic and scientific institutions
    empty
    محققین شاغل در موسسات دانشگاهی و علمی
    empty
    There is no right to extract the article from the documentation.
    empty
    حق استخراج مقاله از مستندات وجود ندارد.
    empty
    Dr. Alireza Khatony
    empty
    دکتر علیرضا خاتونی
    empty
    Within a week of receiving the email, it will be answered.
    empty
    ظرف یک هفته پس از دریافت ایمیل، پاسخ داده میشود.

Protocol summary

Study aim
To determine the effect of aromatherapy with essential oils of lavender and peppermint on the sleep quality of cardiac patients
Design
Clinical trials, with parallel groups, randomized
Settings and conduct
In this study, heart patients hospitalized in Imam Ali Hospital and eligible individuals were randomly divided into three groups (two intervention groups and one control group). For 7 nights at 22 o'clock, in group one, three drops of peppermint essential oil, in group two, three drops of lavender essential oil, and in group three (control group), three drops of distilled water, on a napkin, and held for 20 minutes by the gauze , Will be attached in the chest area.
Participants/Inclusion and exclusion criteria
inclusion criteria include Consent to participate in the study, positive reaction to smell, earn points equal to or more than five from the Pittsburgh sleep quality Index. Exclusion criteria include Unwillingness to continue to cooperate, and administering oxygen for patients.
Intervention groups
In group1,for seven nights at 22 o'clock,the three drops of Peppermint essential oil will be used.Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for20minutes. In group2:for seven nights at 22 o'clock, the three drops of lavender essential oil will be used. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for 20 minutes In control group: for seven nights at 22 o'clock, the three drops of distilled water and is connected to the patient's clothing at the chest and inhaled for20 minutes
Main outcome variables
sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201601244736N10
Registration date: 2016-11-04, 1395/08/14
Registration timing: registered_while_recruiting

Last update: 2018-12-24, 1397/10/03
Update count: 1
Registration date
2016-11-04, 1395/08/14
Registrant information
Name
Alireza Khatony
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
akhatony@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the effect of aromatherapy with the essential oils of lavender and peppermint on cardiac patients' sleep quality
Public title
Comparative evaluation of the effect of aromatherapy with the essential oils of lavender and peppermint on cardiac patients' sleep quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the stud positive reaction to smell he stability of vital signs (blood pressure, pulse, respiration and temperature) having aged 18 to 65 years earn points equal to or more than five from the Pittsburgh sleep quality Index Lack of sinusitis and Pneumonia no addiction to drugs and alcohol Being alert Passed 48 hours of admission not having mental disease and no history of hospitalization in psychiatric wards Do not take caffeine one hour before bedtime
Exclusion criteria:
Unwillingness to continue to cooperate Transition to other wards or death Receiving narcotic and oxygen during aromatherapy critically ill patient during the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Qualified samples were entered into the study by accessible method and randomly divided into intervention groups (peppermint and lavender) and control. Blocks were done as follows: To aromatic groups with peppermint essential oil and Lavender was assigned A and B codes respectively, and the control group received C code. The study blocks were ABC, ACB, BAC, BCA, CAB, CBA, BCC, CAB, CAB, and the ABC block was selected as the first block. Patients were assigned to peppermint, lavender, and control groups, respectively, and this method continued until the samples were completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshty Blv, Kermanshah University of Medical Sciences, Kermanshah, Iran
City
kermanshah
Province
Kermanshah
Postal code
62663455667
Approval date
2016-09-28, 1395/07/07
Ethics committee reference number
kums.rec.1395.380

Health conditions studied

1

Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25.1
ICD-10 code description
Coronary Artery Disease

2

Description of health condition studied
Myocardial infarction
ICD-10 code
I22
ICD-10 code description
Myocardial infarction

3

Description of health condition studied
Congestive heart failure
ICD-10 code
I50.0
ICD-10 code description
Congestive heart failure

Primary outcomes

1

Description
sleep quality
Timepoint
at the beginning of study and Eighth day
Method of measurement
Pittsburgh sleep quality questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In group I, for seven nights before going to sleep at 22 o'clock, the three drops of lavender essential oil will be used. Trade name of this essence is lavender essential oil and its scientific name is Lavandula stoechas which is produced by Tehran Zarband Company. This essential oil will be used in pure form with a concentration of 100 percent. Major chemical compounds included are linalyl acetate and linalool. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for 20 minutes.
Category
Other

2

Description
In group 2, for seven nights before going to sleep at 22 o'clock, the three drops of Peppermint essential oil will be used. Colpermin' is a pharmaceutical brand name for peppermint oil and Its scientific name is Mentha piperita which is produced by Tehran Zarband Company. This essential oil will be used in pure form with a concentration of 100 percent. Major chemical compounds included Menthol, Mentol and methyl acetate. Essential oils will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for 20 minutes.
Category
Other

3

Description
In control group, for seven nights before going to sleep at 22 o'clock, the three drops of distilled water will be used which is produced by Tehran Samen Company. Distilled water will be dropped by the dropper on napkins and is connected to the patient's clothing at the chest and inhaled for 20 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital of Kermanshah
Full name of responsible person
Alireza Khatony
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Email
akhatony@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Street address
Vice chancellor for research, Kermanshah University of Medical Sciences, Shahid Beheshty Blv., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Email
akhatony@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah 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
Kermanshah School of Nursing and Midwifery
Full name of responsible person
alireza khatony
Position
PhD, Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Fax
Email
akhatony@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
PhD in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Fax
Email
akhatony@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
PhD in Nursing Education, Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Fax
Email
akhatony@kums.ac.ir
Web page address

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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
The main consequence is the possibility of sharing information.
When the data will become available and for how long
Six months after the publication of the article
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There is no right to extract the article from the documentation.
From where data/document is obtainable
Dr. Alireza Khatony
What processes are involved for a request to access data/document
Within a week of receiving the email, it will be answered.
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