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2 2024-03-04, 1402/12/14 296148
1 2021-12-24, 1400/10/03 210327
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  • Protocol summary

    Massage intervention in intervention group 1, using 10 ml of olive oil for 15 minutes for each patient's foot in the reflection points of the sole of the foot (solar plexus, pituitary gland and spine). To measure the main outcome variables of the study, patients' respiratory rate, heart rate, arterial blood oxygen saturation, blood pressure and anxiety are recorded; In intervention group 2, the researcher performs the above steps on the patient's hand as in intervention group 1, at first the patient's left hand is lubricated for 1 minute and for 5 minutes with rotating movements to warm up and the next 10 minutes for allocates 5-point reflexology massage including head, pituitary, diaphragm, lung and kidney / adrenal. Then the same steps are done for the right hand
    Massage intervention in intervention group 1, using 3 milliliters of olive oil for 15 minutes for each patient's foot in the reflex points (head, pituitary gland, diaphragm, lungs, solar plexus, and adrenal gland) is performed. To measure the main outcome variables, the number of breaths, heart rate, arterial blood oxygen saturation percentage, blood pressure, and patient anxiety are recorded; in intervention group 2, the researcher also performs the above steps on the patient's hand like group 1, so that the patient's right hand is first lubricated for 1 minute and then the reflex massage intervention is performed on 5 points including head, pituitary gland, diaphragm, lungs, and kidney/adrenal. Then the same steps are performed for the left hand.
    مداخله ماساژ در گروه مداخله1، با استفاده از 10 میلی لیتر روغن زیتون به مدت 15 دقیقه برای هر پای بیماران در نقاط بازتابی کف پا (شبکه خورشیدی، هیپوفیز و ستون مهره ها) صورت می گیرد. برای اندازه گیری متغیر های پیامد اصلی مطالعه تعداد تنفس، ضربان قلب، درصد اشباع اکسیژن خون شریانی، فشار خون و اضطراب بیماران ثبت می گردد؛ در گروه مداخله 2 نیز پژوهشگر مراحل فوق را مانند گروه مداخله 1 بر روی دست بیمار اجرا می کند به طوری که ابتدا دست چپ بیمار را به مدت 1 دقیقه چرب نموده و به مدت 5 دقیقه با حرکات چرخشی برای گرم کردن و 10 دقیقه بعدی برای ماساژ بازتابی 5 نقطه شامل سر، هیپوفیز، دیافراگم، ریه و کلیه /آدرنال اختصاص می دهد. سپس همین مراحل برای دست راست نیز انجام می شود.
    مداخله ماساژ در گروه مداخله1، با استفاده از 3 میلی لیتر روغن زیتون به مدت 15 دقیقه برای هر پای بیماران در نقاط بازتابی کف پا (سر، غده هیپوفیز، دیافراگم، ریه ها، شبکه خورشیدی و غده فوق کلیوی) صورت می گیرد. برای اندازه گیری متغیر های پیامد اصلی مطالعه تعداد تنفس، ضربان قلب، درصد اشباع اکسیژن خون شریانی، فشار خون و اضطراب بیماران ثبت می گردد؛ در گروه مداخله 2 نیز پژوهشگر مراحل فوق را مانند گروه مداخله 1 بر روی دست بیمار اجرا می کند به طوری که ابتدا دست راست بیمار را به مدت 1 دقیقه چرب نموده و سپس مداخله ماساژ بازتابی 5 نقطه شامل سر، هیپوفیز، دیافراگم، ریه و کلیه /آدرنال اختصاص می دهد. سپس همین مراحل برای دست چپ نیز انجام می شود.
    Entry conditions: 1) Colonoscopy candidate 2) Age range 18 to 60 years 3) Colonoscopy candidate for the first time 4) Have a minimum reading and writing literacy to complete the questionnaire No entry conditions: 1) Having emergency colonoscopy order 2) Have previous experience or knowledge of the effects of acupressure
    Entry conditions: 1) Colonoscopy candidate 2) Age range 18 to 65 years 3) Colonoscopy candidate for the first time 4) Have a minimum reading and writing literacy to complete the questionnaire No entry conditions: 1) Having emergency colonoscopy order 2) Have previous experience or knowledge of the effects of acupressure
    شرایط ورود: 1) نیاز به انجام کولونوسکوپی 2) محدوده سنی 18 تا60 سال 3) انجام کولونوسکوپی برای اولین بار 4) داشتن حداقل سواد خواندن و نوشتن براي تكميل پرسشنامه شرایط عدم ورود: 1) دستور انجام کولونوسکوپی اورژانسی 2) داشتن تجربه قبلی و یا آگاهی از تاثیر طب فشاری
    شرایط ورود: 1) نیاز به انجام کولونوسکوپی 2) محدوده سنی 18 تا65 سال 3) انجام کولونوسکوپی برای اولین بار 4) داشتن حداقل سواد خواندن و نوشتن براي تكميل پرسشنامه شرایط عدم ورود: 1) دستور انجام کولونوسکوپی اورژانسی 2) داشتن تجربه قبلی و یا آگاهی از تاثیر طب فشاری
    Intervention group 1: Performing reflexology intervention on the reflection points of plantar (solar plexus, pituitary gland and spine) Intervention group 2: Acupressure in the palm of patient's Control group: No intervention
    Intervention group 1: Performing reflexology intervention on the reflection points of plantar Intervention group 2: Acupressure in the palm of patient's Control group: No intervention
    گروه مداخله1: انجام مداخله رفلکسولوژی در نقاط بازتابی کف پا (شبکه خورشیدی، هیپوفیز و ستون مهره ها) به مدت 15 دقیقه برای هر پا؛ گروه مداخله 2: انجام طب فشاری در کف دست بیماران گروه کنترل: عدم مداخله
    گروه مداخله1: انجام مداخله رفلکسولوژی در نقاط بازتابی کف پا به مدت 15 دقیقه برای هر پا؛ گروه مداخله 2: انجام طب فشاری در کف دست بیماران گروه کنترل: عدم مداخله
  • General information

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    به روز رسانی بر اساس مطالعه نتایج مقدماتی
    Colonoscopy candidate
    Age range 18 to 60 years
    Signing an informed consent form
    Colonoscopy candidate for the first time
    Have a minimum reading and writing literacy to complete the questionnaire
    Colonoscopy candidate
    Age range 18 to 65 years
    Signing an informed consent form
    Colonoscopy candidate for the first time
    Have a minimum reading and writing literacy to complete the questionnaire
    نیاز به انجام کولونوسکوپی(بنابر تشخیص پزشک معالج)
    محدوده سنی 18 تا60 سال
    امضاء فرم رضایت نامه آگاهانه
    انجام کولونوسکوپی برای اولین بار
    داشتن حداقل سواد خواندن و نوشتن براي تكميل پرسشنامه؛
    نیاز به انجام کولونوسکوپی(بنابر تشخیص پزشک معالج)
    محدوده سنی 18 تا65 سال
    امضاء فرم رضایت نامه آگاهانه
    انجام کولونوسکوپی برای اولین بار
    داشتن حداقل سواد خواندن و نوشتن براي تكميل پرسشنامه؛
    Samples are selected in an available sampling way from all colonoscopy candidate patients admitted to Amir Al-Momenin Hospital in Arak. Then patients with equal number of members (1:1) are randomly assigned to each of the intervention and control groups. Due to the gradual entry of samples into the research in this research, random allocation is done by a random sequence method by a table of random numbers in Excel software. To avoid the bias of random selection of individuals to study, groups are hidden and this sequence remains hidden until the intervention. For this purpose, consecutive dark and numbered envelopes are used to enclose the sequences.
    Samples are selected in an available sampling way from all colonoscopy candidate patients admitted to Amir Al-Momenin Hospital in Arak. Then patients with an equal number of members are randomly assigned to each of the intervention and control groups. The block randomization method will be used. To avoid the bias of random selection of individuals to study, groups are hidden and this sequence remains hidden until the intervention. For this purpose, consecutive dark and numbered envelopes are used to enclose the sequences.
    انتخاب نمونه ها به شیوه در دسترس (آسان) از میان کلیه بیماران نیازمند کولونوسکوپی بستری در بیمارستان امیرالمومنین شهر اراک صورت می گیرد. سپس بیماران با تعداد اعضای برابر(1:1) به روش تخصیص تصادفی، در هر یک از گروه های مداخله و کنترل قرار می گیرد. با توجه به ورود تدریجی نمونه ها به پژوهش در این تحقیق از تخصیص تصادفی به روش توالی تصادفی پشت سر هم توسط جدول اعداد تصادفی در نرم افزار اکسل صورت می پذیرد. جهت اجتناب از سوگيري انتخاب تخصيص تصادفی افراد به گروه های مطالعه پنهان سازی می شوند و اين توالی تا زمان انجام مداخلات پوشيده می ماند. بدین منظور از پاكت های تيره و شماره دار متوالی جهت محصور كردن توالی ها استفاده می شود.
    انتخاب نمونه ها به شیوه در دسترس از میان کلیه بیماران نیازمند کولونوسکوپی بستری در بیمارستان امیرالمومنین شهر اراک صورت می گیرد. سپس بیماران با تعداد اعضای برابر به روش تخصیص تصادفی، در هر یک از گروه های مداخله و کنترل قرار می گیرد. از روش تصادفی سازی بلوکی استفاده خواهد شد. جهت اجتناب از سوگيري انتخاب تخصيص تصادفی افراد به گروه های مطالعه پنهان سازی می شوند و اين توالی تا زمان انجام مداخلات پوشيده می ماند. بدین منظور از پاكت های تيره و شماره دار متوالی جهت محصور كردن توالی ها استفاده می شود.
    The blind groups in this study include patients, an assistant research collector, and a statistician; in such a way that none of the patients and also the data collector were aware of the allocation of patients to the two intervention and control groups and also the data obtained from this study without informing the statistical expert about the allocation of data to each intervention and control groups, will be analyzed. (Explanation: In this study, the person collecting information is different from the person performing the intervention).
    The blind groups in this study include patients, data collectors, and a statistician; in such a way that none of the data collectors were aware of the allocation of patients to the two intervention and control groups, and also the data obtained from this study without informing the statistical expert about the allocation of data to each intervention and control groups, will be analyzed.
    گروه های کورشده در این مطالعه شامل بیماران، کمک پژوهشگر جمع آوری کننده اطلاعات و کارشناس آمار است؛ به نحوی که هیچ کدام از بیماران و همچنین فرد جمع آوری کننده اطلاعات از تخصیص بیماران به دو گروه مداخله و کنترل آگاهی نداشته و همچنین داده های حاصل از این مطالعه بدون اطلاع کارشناس آمار از تخصیص داده ها به هر یک از گروه های مداخله و کنترل، مورد تجزیه و تحلیل قرار می گیرد. (توضیح: در این مطالعه فرد جمع آوری کننده اطلاعات متمایز از فردی است که مداخله را انجام می دهد).
    گروه های کورشده در این مطالعه شامل بیماران، افراد جمع آوری کننده اطلاعات و کارشناس آمار است؛ به نحوی که افراد جمع آوری کننده اطلاعات از تخصیص بیماران به گروه های مداخله و کنترل آگاهی نداشته و همچنین داده ها حاصل از این مطالعه بدون اطلاع کارشناس آمار از تخصیص داده ها به هر یک از گروه های مداخله و کنترل، مورد تجزیه و تحلیل قرار می گیرد.
  • Secondary outcomes

    #1
    5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention
    Before the intervention, immediately before the intervention, after the intervention
    5 دقیقه قبل از مداخله، بلافاصله قبل مداخله، بلافاصله بعد از مداخله، 5 دقیقه بعد از مداخله
    قبل از مداخله، بلافاصله قبل مداخله، بعد از مداخله
    #2
    5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention
    Before the intervention, immediately before the intervention, after the intervention
    ۵ دقیقه قبل از مداخله، بلافاصله قبل مداخله، بلافاصله بعد از مداخله، 5 دقیقه بعد از مداخله
    قبل از مداخله، بلافاصله قبل مداخله، بعد از مداخله
    #3
    5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention
    Before the intervention, immediately before the intervention, after the intervention
    ۵ دقیقه قبل از مداخله، بلافاصله قبل مداخله، بلافاصله بعد از مداخله، 5 دقیقه بعد از مداخله
    قبل از مداخله، بلافاصله قبل مداخله، بعد از مداخله
    #4
    5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention
    Before the intervention, immediately before the intervention, after the intervention
    ۵ دقیقه قبل از مداخله، بلافاصله قبل مداخله، بلافاصله بعد از مداخله، 5 دقیقه بعد از مداخله
    قبل از مداخله، بلافاصله قبل مداخله، بعد از مداخله
  • Intervention groups

    #1
    Intervention group1: Performing massage intervention in the reflection points of the sole of the foot. For this purpose, the researcher will start the massage intervention 10 minutes after the patients enter the bed where they are hospitalized, after passing the reflexology training course and gaining the necessary skills. First, the researcher takes out his watch, ring, and jewelry and washes and warms his hands. Then, the researcher intervenes by being at the end of the patient's bed and observing a suitable position (to create better comfort, a small pillow is placed under the patient's knees).In the intervention group, to facilitate massage and better reflexology effect, 10 ml of pure olive oil with a temperature of 18-25 ° C is used. In the first step, lubricate the patient's foot for 1 minute and begin reflexology intervention. The massage of the left foot at a slow pace, with a regular rhythm and with a depth that is tolerable by the patient lasts for 15 minutes. 5 minutes is for general massage of the sole of the foot and the next 10 minutes is for the relief of pain and anxiety caused by the procedure in the reflection points of the sole of the foot (points of the solar plexus, pituitary and spine). Then the same steps are performed on the patient's right foot. In order to reduce the likelihood of distraction in patients, the intervention will be performed in a quiet and closed environment (if possible). It should be noted that massage intervention is performed for male patients by male researcher assistance and for female patients by a female colleague.
    Intervention group1: Performing massage intervention in the reflection points of the sole of the foot. For this purpose, the researcher will start the massage intervention 10 minutes after the patients enter the bed where they are hospitalized, after passing the reflexology training course and gaining the necessary skills. First, the researcher takes out his watch, ring, and jewelry and washes and warms his hands. Then, the researcher intervenes by being at the end of the patient's bed and observing a suitable position (to create better comfort, a small pillow is placed under the patient's knees).In the intervention group, to facilitate massage and better reflexology effect, 3 ml of pure olive oil with a temperature of 18-25 ° C is used. In the first step, lubricate the patient's foot for 1 minute and begin reflexology intervention. The massage of the right foot at a slow pace, with a regular rhythm and with a depth that is tolerable by the patient lasts for 15 minutes. Reflex points include the head, pituitary gland, diaphragm, lungs, solar plexus, and adrenal gland. Then the same steps are performed on the patient's left foot. In order to reduce the likelihood of distraction in patients, the intervention will be performed in a quiet and closed environment (if possible). It should be noted that massage intervention is performed for male patients by male researcher assistance and for female patients by a female colleague.
    گروه مداخله1: انجام مداخله ماساژ در نقاط بازتابی کف پا، بدین منظور پژوهشگر پس از گذراندن دوره آموزشی رفلکسولوژی و کسب مهارت لازم، 10 دقیقه بعد از ورود بیماران به تختی که در آن بستری هستند مداخله ماساژ را شروع خواهد نمود. ابتدا پژوهشگر ساعت، حلقه و جواهرات دست خود را خارج کرده و دست های خود رو شسته و گرم می کند. سپس با قرار گرفتن در انتهای تخت بیمار و با رعایت پوزیشنی مناسب به انجام مداخله می پردازد (جهت ایجاد راحتی بهتر بالشتی کوچک در زیر زانوها بیمار قرار می دهد). در گروه مداخله برای تسهیل انجام ماساژ و تاثیر بهتر رفلکسولوژی از 10 میلی لیتر روغن زیتون با دمای 18-25 درجه سانتی گراد به صورت خالص استفاده می شود. در گام نخست به مدت 1 دقیقه پای بیمار را چرب نموده و شروع به انجام مداخله رفلکسولوژی کرده، ماساژ از پای چپ با سرعت آرام، با ريتم منظم و با عمقي كه در حد تحمل بيمار باشد به مدت 15 دقیقه (برای هر پا) به طول می انجامد. که 5 دقیقه آن به منظور ماساژ عمومی کف پا بوده و 10 دقیقه بعدی آن جهت تسکین درد و اضطراب ناشی از پروسیجر در نقاط بازتابی کف پا (نقاط شبکه خورشیدی، هیپوفیز و ستون مهره ها) است. سپس همین مراحل بر روی پای راست بیمار نیز انجام می شود. به منظور کاهش احتمال حواس پرتی در بیماران مداخله در محیطی آرام و دربسته (در صورت امکان) انجام خواهد شد. لازم به ذکر است انجام مداخله ماساژ برای بیماران آقا توسط کمک پژوهشگر آقا و برای بیماران خانم توسط همکار خانم صورت می گیرد.
    گروه مداخله1: انجام مداخله ماساژ در نقاط بازتابی کف پا، بدین منظور پژوهشگر پس از گذراندن دوره آموزشی رفلکسولوژی و کسب مهارت لازم، مداخله ماساژ را شروع خواهد نمود. ابتدا پژوهشگر ساعت، حلقه و جواهرات دست خود را خارج کرده و دست های خود رو شسته و گرم می کند. سپس با قرار گرفتن در انتهای تخت بیمار و با رعایت پوزیشنی مناسب به انجام مداخله می پردازد (جهت ایجاد راحتی بهتر بالشتی کوچک در زیر زانوها بیمار قرار می دهد). در گروه مداخله برای تسهیل انجام ماساژ و تاثیر بهتر رفلکسولوژی از ۳ میلی لیتر روغن زیتون با دمای 18-25 درجه سانتی گراد به صورت خالص استفاده می شود. در گام نخست به مدت 1 دقیقه پای بیمار را چرب نموده و شروع به انجام مداخله رفلکسولوژی کرده، ماساژ از پای راست با سرعت آرام، با ريتم منظم و با عمقي كه در حد تحمل بيمار باشد به مدت 15 دقیقه (برای هر پا) به طول می انجامد. نقاط بازتابی شامل سر، غده هیپوفیز، دیافراگم، ریه، شبکه خورشیدی و غده فوق کلیوی است. سپس همین مراحل بر روی پای چپ بیمار نیز انجام می شود. به منظور کاهش احتمال حواس پرتی در بیماران مداخله در محیطی آرام و دربسته (در صورت امکان) انجام خواهد شد. لازم به ذکر است انجام مداخله ماساژ برای بیماران آقا توسط کمک پژوهشگر آقا و برای بیماران خانم توسط همکار خانم صورت می گیرد.
    #2
    Intervention group2: In intervention group 2, the researcher performs the above steps on the patient's hand as in intervention group 1, so that the researcher first lubricates the patient's left hand for 1 minute and then performs rotational movements for 5 minutes to warm up. And spends the next 10 minutes massaging the He7 spot. Then the same steps are done for the right hand
    Intervention group2: In intervention group 2, the researcher performs the above steps on the patient's hand as in intervention group 1, so that the researcher first lubricates the patient's right hand for 1 minute and begin reflexology intervention. The massage of the right hand at a slow pace, with a regular rhythm and with a depth that is tolerable by the patient lasts for 15 minutes. Reflex points include the head, pituitary gland, diaphragm, lungs, solar plexus, and adrenal gland. Then the same steps are done for the left hand
    گروه مداخله2: در گروه مداخله 2، نیز پژوهشگر مراحل فوق را مانند گروه مداخله 1 بر روی دست بیمار اجرا می کند به طوری که ابتدا دست چپ بیمار را به مدت 1 دقیقه چرب نموده و به مدت 5 دقیقه با حرکات چرخشی برای گرم کردن و 10 دقیقه بعدی برای ماساژ بازتابی 5 نقطه شامل سر، هیپوفیز، دیافراگم، ریه و کلیه /آدرنال اختصاص می دهد. سپس همین مراحل برای دست راست نیز انجام می شود.
    گروه مداخله2: در گروه مداخله 2، نیز پژوهشگر مراحل فوق را مانند گروه مداخله 1 بر روی دست بیمار اجرا می کند به طوری که ابتدا دست راست بیمار را به مدت 1 دقیقه چرب نموده و شروع به انجام مداخله رفلکسولوژی کرده، ماساژ از دست راست با سرعت آرام، با ريتم منظم و با عمقي كه در حد تحمل بيمار باشد به مدت 15 دقیقه (برای هر پا) به طول می انجامد. نقاط بازتابی شامل سر، غده هیپوفیز، دیافراگم، ریه، شبکه خورشیدی و غده فوق کلیوی است. سپس همین مراحل برای دست چپ نیز انجام می شود.

Protocol summary

Study aim
The effect of solar plexus point reflexology of plantar and palmar acupressure on anxiety and physiological parameters of patients undergoing colonoscopy is examined.
Design
In this clinical trial study, 105 patients admitted to Amir Al-Momenin Hospital in Arak who have eligible criteria for the study are randomly divided into three groups of intervention 1, intervention 2 and control.
Settings and conduct
Massage intervention in intervention group 1, using 3 milliliters of olive oil for 15 minutes for each patient's foot in the reflex points (head, pituitary gland, diaphragm, lungs, solar plexus, and adrenal gland) is performed. To measure the main outcome variables, the number of breaths, heart rate, arterial blood oxygen saturation percentage, blood pressure, and patient anxiety are recorded; in intervention group 2, the researcher also performs the above steps on the patient's hand like group 1, so that the patient's right hand is first lubricated for 1 minute and then the reflex massage intervention is performed on 5 points including head, pituitary gland, diaphragm, lungs, and kidney/adrenal. Then the same steps are performed for the left hand.
Participants/Inclusion and exclusion criteria
Entry conditions: 1) Colonoscopy candidate 2) Age range 18 to 65 years 3) Colonoscopy candidate for the first time 4) Have a minimum reading and writing literacy to complete the questionnaire No entry conditions: 1) Having emergency colonoscopy order 2) Have previous experience or knowledge of the effects of acupressure
Intervention groups
Intervention group 1: Performing reflexology intervention on the reflection points of plantar Intervention group 2: Acupressure in the palm of patient's Control group: No intervention
Main outcome variables
Respiration rate, heart rate, arterial blood oxygen saturation, blood pressure, anxiety

General information

Reason for update
Update based on pilot study results
Acronym
IRCT registration information
IRCT registration number: IRCT20190524043687N3
Registration date: 2021-12-24, 1400/10/03
Registration timing: prospective

Last update: 2024-03-04, 1402/12/14
Update count: 1
Registration date
2021-12-24, 1400/10/03
Registrant information
Name
Ali Safdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 5861 5962
Email address
asafdari.nu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-08, 1400/10/18
Expected recruitment end date
2022-08-09, 1401/05/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of solar plexus point reflexology of plantar and palmar on anxiety and physiological parameters of patients undergoing colonoscopy
Public title
Comparison of the effect of solar plexus point reflexology of plantar and palmar on anxiety and physiological parameters of patients undergoing colonoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Colonoscopy candidate Age range 18 to 65 years Signing an informed consent form Colonoscopy candidate for the first time Have a minimum reading and writing literacy to complete the questionnaire
Exclusion criteria:
Having emergency colonoscopy order Have previous experience or knowledge of the effects of acupressure Lack of full consciousness, having mental, visual and auditory disorders Drug addiction Existence of an obstacle at the site of pressure (wounds, skin diseases, etc) Existence of sensory and motor disorders in the legs and minimal ability to walk on the legs (peripheral neuropathy or vascular problems in the lower extremities)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are selected in an available sampling way from all colonoscopy candidate patients admitted to Amir Al-Momenin Hospital in Arak. Then patients with an equal number of members are randomly assigned to each of the intervention and control groups. The block randomization method will be used. To avoid the bias of random selection of individuals to study, groups are hidden and this sequence remains hidden until the intervention. For this purpose, consecutive dark and numbered envelopes are used to enclose the sequences.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The blind groups in this study include patients, data collectors, and a statistician; in such a way that none of the data collectors were aware of the allocation of patients to the two intervention and control groups, and also the data obtained from this study without informing the statistical expert about the allocation of data to each intervention and control groups, will be analyzed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Arak University of Medical Sciences
Street address
Sardasht St., Basij Square, Ethics Committee of Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-11-14, 1400/08/23
Ethics committee reference number
IR.ARAKMU.REC.1400.226

Health conditions studied

1

Description of health condition studied
Abnormal findings on diagnostic imaging and in function studies, without diagnosis
ICD-10 code
R93.8
ICD-10 code description
Abnormal findings on diagnostic imaging of other specified body structures

2

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Anxiety
Timepoint
Before intervention, immediately before intervention and after intervention
Method of measurement
The State-Trait Anxiety Inventory-Spielberger

Secondary outcomes

1

Description
Heart beat
Timepoint
Before the intervention, immediately before the intervention, after the intervention
Method of measurement
Number of beats per minute - pulse oximeter

2

Description
Arterial blood oxygen saturation (SPO2)
Timepoint
Before the intervention, immediately before the intervention, after the intervention
Method of measurement
Percentage - pulse oximeter

3

Description
Respiratory rate
Timepoint
Before the intervention, immediately before the intervention, after the intervention
Method of measurement
Count per minute - count breathing by observation

4

Description
Blood pressure
Timepoint
Before the intervention, immediately before the intervention, after the intervention
Method of measurement
By sphygmomanometer

Intervention groups

1

Description
Intervention group1: Performing massage intervention in the reflection points of the sole of the foot. For this purpose, the researcher will start the massage intervention 10 minutes after the patients enter the bed where they are hospitalized, after passing the reflexology training course and gaining the necessary skills. First, the researcher takes out his watch, ring, and jewelry and washes and warms his hands. Then, the researcher intervenes by being at the end of the patient's bed and observing a suitable position (to create better comfort, a small pillow is placed under the patient's knees).In the intervention group, to facilitate massage and better reflexology effect, 3 ml of pure olive oil with a temperature of 18-25 ° C is used. In the first step, lubricate the patient's foot for 1 minute and begin reflexology intervention. The massage of the right foot at a slow pace, with a regular rhythm and with a depth that is tolerable by the patient lasts for 15 minutes. Reflex points include the head, pituitary gland, diaphragm, lungs, solar plexus, and adrenal gland. Then the same steps are performed on the patient's left foot. In order to reduce the likelihood of distraction in patients, the intervention will be performed in a quiet and closed environment (if possible). It should be noted that massage intervention is performed for male patients by male researcher assistance and for female patients by a female colleague.
Category
Treatment - Other

2

Description
Intervention group2: In intervention group 2, the researcher performs the above steps on the patient's hand as in intervention group 1, so that the researcher first lubricates the patient's right hand for 1 minute and begin reflexology intervention. The massage of the right hand at a slow pace, with a regular rhythm and with a depth that is tolerable by the patient lasts for 15 minutes. Reflex points include the head, pituitary gland, diaphragm, lungs, solar plexus, and adrenal gland. Then the same steps are done for the left hand
Category
Treatment - Other

3

Description
Control group: There is no special intervention in the control group and these patients receive only routine care.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Ali Safdari
Street address
No. Arak, Sardasht, Basij Square, Amiralmomenin hospital
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5001
Email
asafdari.nu@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aliraza Kamali
Street address
No. Arak, Sardasht, Basij Square, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Ali Safdari
Position
Nursing student of Arak University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. Arak, Sardasht, Basij Square, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
asafdari.nu@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Razieh Mokhtari
Position
Member of Arak Nursing Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. Arak, Sardasht, Basij Square, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
razieh.mokhtari91@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Safdari
Position
Nursing student of Arak University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. Arak, Sardasht, Basij Square, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
asafdari.nu@gmail.com

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
Yes - There is a plan to make this available
Informed Consent Form
No - There is not 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
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
Shared data include demographic information of participants' patients, type and method of intervention, information about anxiety, pain and physiological indicators of participants before and after the intervention.
When the data will become available and for how long
Start the access period 6 months after the results are published.
To whom data/document is available
Researchers and people working in nursing as well as people working in clinical nursing
Under which criteria data/document could be used
The obtained data can be used for education, research and clinic of nursing. The applicant must be in the field of nursing. The data applicant should use the data only for education, research and clinic of nursing.
From where data/document is obtainable
Ali Safdari, Department of critical care nursing, school of nursing, Arak university of medical sciences E mail:asafdari.nu@gmail.com
What processes are involved for a request to access data/document
After confirming that the data requester is in the field of nursing, the type of request will be answered immediately via email.
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