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Protocol summary
determine the effect of discharge plan program on sexual knowledge and quality of life of patient after Invasive coronary intervention
determine the effect of councelling program on sexual knowledge and quality of life and DASS21 score of patients(men) after Invasive coronary intervention
determine the effect of discharge plancouncelling program on sexual knowledge and quality of life and DASS21 score of patientpatients(men) after Invasive coronary intervention
تعیین تاثیر بسته آموزش حین ترخیص روی دانش وکیفیت زندگی جنسی بیماران پس از درمان های تهاجمی عروق کرونر
تعیین تاثیر مشاوره حین ترخیص روی دانش وکیفیت زندگی جنسی و شاخص DASS21 بیماران مرد پس از درمان های تهاجمی عروق کرونر
تعیین تاثیر بسته آموزشمشاوره حین ترخیص روی دانش وکیفیت زندگی جنسی و شاخص DASS21 بیماران مرد پس از درمان های تهاجمی عروق کرونر
allocated to 2 group intervention give discharge plan consult and conventional education
This study is a clinical trial (phase 3) with a control group, with parallel groups, single-blind, randomized, on 56 patients. All male patients with inclusion and exclusion criteria were entered into the study and randomly allocated to the groups by the Rand calculator function.
This study is a clinical trial (phase 3) with a control group, with parallel groups, single-blind, randomized, on 56 patients. All male patients with inclusion and exclusion criteria were entered into the study and randomly allocated to 2 group intervention give discharge plan consult and conventional educationthe groups by the Rand calculator function.
بیمارانی که به تدریج پس از مداخلات تهاجمی کرونر ترخیص می شوند به دو گروه دریافت کننده آموزش حین ترخیص و آموزش طبق برنامه روتین تقسیم می شوند
این مطالعه یک کارآزمایی بالینی (فاز ۳) دارای گروه کنترل، با گروه های موازی ، یک سویه کور ، تصادفی شده، بر روی ۵۶ بیمار می باشد که کلیه بیماران مرد دارای معیارهای ورود و خروج وارد مطالعه شدند و به صورت تصادفی در گروه ها تخصیص داده شدند. برای تخصیص در گروه ها بصورت تصادفی از اعداد rand ماشین حساب استفاده شد.
بیمارانیاین مطالعه یک کارآزمایی بالینی (فاز ۳) دارای گروه کنترل، با گروه های موازی ، یک سویه کور ، تصادفی شده، بر روی ۵۶ بیمار می باشد که کلیه بیماران مرد دارای معیارهای ورود و خروج وارد مطالعه شدند و به تدریج پسصورت تصادفی در گروه ها تخصیص داده شدند. برای تخصیص در گروه ها بصورت تصادفی از مداخلات تهاجمی کرونر ترخیص می شوند به دو گروه دریافت کننده آموزش حین ترخیص و آموزش طبق برنامه روتین تقسیم می شونداعداد rand ماشین حساب استفاده شد.
in post cath ward of shahid beheshti hospital (kashan) after patient assessment and allocation in 2 groups by main researcher(assistant professor), the student (intern) should intervention (presentation and delivering the sexual activity package )
In the post cath ward of Shahid Beheshti hospital in Kashan, at the time of discharge, patients were evaluated and after being allocated to study groups, the researcher provided training and counseling to patients.
inIn the post cath ward of shahid beheshtiShahid Beheshti hospital (kashan)in Kashan, at the time of discharge, patients were evaluated and after patient assessment and allocation in 2being allocated to study groups by main researcher(assistant professor), the student (intern) should intervention (presentationresearcher provided training and delivering the sexual activity package )counseling to patients.
در بخش پست کت بیمارستان شهید بهشتی کاشان در زمان ترخیص بیماران ارزیابی و پس از تخصیص آنها توسط محقق اصلی ، اینترن محقق بر اساس شماره دریافتی اقدام به آموزش و تحویل بسته آموزشی مورد تایید قرار گرفته ، می نماید.
در بخش پست کت بیمارستان شهید بهشتی کاشان در زمان ترخیص، بیماران ارزیابی و پس از تخصیص به گروه های مطالعه ، محقق اقدام به آموزش و مشاوره بیماران می نمود.
در بخش پست کت بیمارستان شهید بهشتی کاشان در زمان ترخیص، بیماران ارزیابی و پس از تخصیص آنها توسط محقق اصلیبه گروه های مطالعه ، اینترن محقق بر اساس شماره دریافتی اقدام به آموزش و تحویل بسته آموزشی مورد تایید قرار گرفته ،مشاوره بیماران می نمایدنمود.
all of patient under PTCA or CABG intervention at discharging time
Married male patients; aged 35-65 years; undergoing CABG and PTCA treatment; no severe physical illness, addiction, known psychiatric problem, or previous sexual dysfunction at the time of discharge.
allMarried male patients; aged 35-65 years; undergoing CABG and PTCA treatment; no severe physical illness, addiction, known psychiatric problem, or previous sexual dysfunction at the time of patient under PTCA or CABG intervention at discharging timedischarge.
کلیه بیماران تحت درمان CABG و PTCA در زمان ترخیص
بیماران مرد متاهل ۳۵-۶۵ ساله تحت درمان CABG و PTCA که در زمان ترخیص فاقد بیماری شدید جسمانی، اعتیاد، مشکل شناخته شده ی روان پزشکی و اختلال عملکرد جنسی قبلی بودند.
کلیه بیماران مرد متاهل ۳۵-۶۵ ساله تحت درمان CABG و PTCA که در زمان ترخیص فاقد بیماری شدید جسمانی، اعتیاد، مشکل شناخته شده ی روان پزشکی و اختلال عملکرد جنسی قبلی بودند.
patients that receive with discharge sexual activity package at discharging time
Patients who received sexual activity guidance counseling at discharge were called an intervention group, and the control group was provided with routine nursing training, and no intervantion counseling was provided.
patients that receive with dischargePatients who received sexual activity packageguidance counseling at discharging timedischarge were called an intervention group, and the control group was provided with routine nursing training, and no intervantion counseling was provided.
بیمارانی که بسته آموزشی راهنمای فعالیت جنسی را در زمان ترخیص دریافت می کنند
بیمارانی که مشاوره راهنمای فعالیت جنسی را در زمان ترخیص دریافت می کنند گروه مداخله نامیده می شوند و در گروه کنترل آموزش های روتین پرستاری ارایه می شود و مشاوره جدیدی ارایه نمیشود.
بیمارانی که بسته آموزشیمشاوره راهنمای فعالیت جنسی را در زمان ترخیص دریافت می کنند گروه مداخله نامیده می شوند و در گروه کنترل آموزش های روتین پرستاری ارایه می شود و مشاوره جدیدی ارایه نمیشود.
sexual knowledge and sexual quality of life
Sexual knowledge; sexual quality of life
sexualSexual knowledge and; sexual quality of life
General information
empty
empty
56
56
No
No
empty
2018-04-04, 1397/01/15
2018-04-04 00:00:00
empty
2018-09-06, 1397/06/15
2018-09-06 00:00:00
empty
2018-11-22, 1397/09/01
2018-11-22 00:00:00
empty
adding extra secondary outcome
adding extra secondary outcome
empty
اضافه کردن در پیامدهای ثانویه
اضافه کردن در پیامدهای ثانویه
effect of discharge planing on knowledge and Sexual Quality of Life in patient
Effect of discharge counselling on knowledge and Sexual Quality of Life and DASS21 score in patients (men)
effectEffect of discharge planingcounselling on knowledge and Sexual Quality of Life and DASS21 score in patientpatients (men)
تاثیر برنامه ترخیص روی دانش وکیفیت زندگی جنسی حین ترخیص بیماران
تاثیر مشاوره روی دانش وکیفیت زندگی جنسی و شاخص DASS21 حین ترخیص بیماران مرد
تاثیر برنامه ترخیصمشاوره روی دانش وکیفیت زندگی جنسی و شاخص DASS21 حین ترخیص بیماران مرد
Effect of discharge plan box on knowledge and Sexual Quality of Life in post CABG and PTCA patients
Effect of sexual counseling on knowledge, Sexual Quality of Life and DASS21 score in post CABG and PTCA patients (men)
Effect of discharge plan boxsexual counseling on knowledge and, Sexual Quality of Life and DASS21 score in post CABG and PTCA patients (men)
تاثیر بسته آموزش حین ترخیص روی دانش وکیفیت زندگی جنسی بیماران پس از درمان های تهاجمی عروق کرونر (CABG و PTCA)
تاثیر مشاوره حین ترخیص روی دانش،کیفیت زندگی جنسی و شاخص DASS21 بیماران مرد پس از درمان های تهاجمی عروق کرونر (CABG و PTCA)
تاثیر بسته آموزشمشاوره حین ترخیص روی دانش وکیفیت،کیفیت زندگی جنسی و شاخص DASS21 بیماران مرد پس از درمان های تهاجمی عروق کرونر (CABG و PTCA)
patient can read and write
patient must be married and living with partner
patient should not have any known sexual dysfunction
patient should not have any known psychological disorder
hospitalized patient in post ICU open heart or post Catheterization
patient should not have any limitation in sexual activity
patient can read and write
patient must be married and living with partner
patient can read and write patient must be married and living with partner patient should not have any known sexual dysfunction patient should not have any known psychological disorder hospitalized patient in post ICU open heart or post Catheterization patient should not have any limitation in sexual activity
بیمار سواد خواندن و نوشتن داشته باشد
بیمار متاهل و در کنار همسرش زندگی کند. (بیمار شریک جنسی داشته باشد)
عدم وجود اختلالات جنسی قبل از مداخله ی جراحی
عدم وجود مشکل روانی شناخته شده در بیمار
بیماران بستری در بخش های post ICU open heart یا پست کت که به علت بیماری ایسکمی قلب تحت CABG,PTCA قرار گرفته است
عدم داشتن منع رابطه جنسی به تشخیص پزشک بعد از شروع مشکلات قلبی
بیمار سواد خواندن و نوشتن داشته باشد
بیمار متاهل و در کنار همسرش زندگی کند. (بیمار شریک جنسی داشته باشد)
بیمار سواد خواندن و نوشتن داشته باشد بیمار متاهل و در کنار همسرش زندگی کند. (بیمار شریک جنسی داشته باشد) عدم وجود اختلالات جنسی قبل از مداخله ی جراحی عدم وجود مشکل روانی شناخته شده در بیمار بیماران بستری در بخش های post ICU open heart یا پست کت که به علت بیماری ایسکمی قلب تحت CABG,PTCA قرار گرفته است عدم داشتن منع رابطه جنسی به تشخیص پزشک بعد از شروع مشکلات قلبی
heart, liver, pulmonary and kidney failure or malignancy or any systemic disease
use of antipsychotic or cytotoxic drug
severe heart failure (function class III or IV (NYHA))
heart, liver, pulmonary and kidney failure or malignancy or any systemic disease
use of antipsychotic or cytotoxic drug
severe heart failure (function class III or IV (NYHA))
alcohol or opium abuse (based on the patient statement)
existence of current depression, anxiety, stress based on DASS-21 score (depression score<10 or anxiety score<8 or stress score<15)
current known sexual dysfunction
current known psychological disorder
heart, liver, pulmonary and kidney failure or malignancy or any systemic disease use of antipsychotic or cytotoxic drug severe heart failure (function class III or IV (NYHA)) alcohol or opium abuse (based on the patient statement) existence of current depression, anxiety, stress based on DASS-21 score (depression score<10 or anxiety score<8 or stress score<15) current known sexual dysfunction current known psychological disorder
نارسایی شدید کلیوی ، ریوی ، کبدی و بدخیمی و هر گونه بیماری سیستمیک
مصرف داروهای سیتوتوکسیک و آنتی سایکوتیک
نارسایی شدید قلبی (NYHA Class 3 , 4)
نارسایی شدید کلیوی ، ریوی ، کبدی و بدخیمی و هر گونه بیماری سیستمیک
مصرف داروهای سیتوتوکسیک و آنتی سایکوتیک
نارسایی شدید قلبی (NYHA Class 3 , 4)
مصرف الکل یا مواد مخدر (به گفت خود بیمار)
وجود افسردگی یا اضطراب یا استرس طبق شاخص DASS-21 (شاخص افسردگی>۱۰ یا شاخص اضطراب>۸ یا شاخص استرس>۱۵)
وجود اختلالات جنسی قبل از مداخله ی جراحی
وجود مشکل روانی شناخته شده در بیمار
نارسایی شدید کلیوی ، ریوی ، کبدی و بدخیمی و هر گونه بیماری سیستمیک مصرف داروهای سیتوتوکسیک و آنتی سایکوتیک نارسایی شدید قلبی (NYHA Class 3 , 4) مصرف الکل یا مواد مخدر (به گفت خود بیمار) وجود افسردگی یا اضطراب یا استرس طبق شاخص DASS-21 (شاخص افسردگی>۱۰ یا شاخص اضطراب>۸ یا شاخص استرس>۱۵) وجود اختلالات جنسی قبل از مداخله ی جراحی وجود مشکل روانی شناخته شده در بیمار
The sampling method is continuous and patients are divided into 4 randomized blocks between intervention and control groups.
The sampling method was continuous, and all male patients admitted during the study who had inclusion criteria were admitted to the study at the time of discharge and remained in the study if they did not have exclusion criteria. Then they were allocated to the intervention or control group randomly by random computer numbers (calculator). Conventionally in the study, random multiple numbers 2 placed the patient in the intervention group, and non-multiple random numbers 2 placed the patient in the control group.
The sampling method iswas continuous, and all male patients are divided into 4 randomized blocks betweenadmitted during the study who had inclusion criteria were admitted to the study at the time of discharge and remained in the study if they did not have exclusion criteria. Then they were allocated to the intervention andor control groupsgroup randomly by random computer numbers (calculator). Conventionally in the study, random multiple numbers 2 placed the patient in the intervention group, and non-multiple random numbers 2 placed the patient in the control group.
نحوه نمونه گیری به طور مستمر بوده که بیماران به صورت بلوک 4 تای تصادفی بین گروه مداخله و کنترل تخصیص می شوند.
نحوه نمونه گیری به طور مستمر بوده و کلیه بیماران مرد بستری در طول مطالعه که دارای معیارهای ورود بودند، همگی در زمان ترخیص وارد مطالعه می شدند و در صوتیکه فاقد معیارهای خروج بودند در مطالعه باقی می ماندند و بوسیله اعداد رندوم کامپیوتری (ماشین حساب) در گروه مداخله یا کنترل تخصیص داده میشدند. به طور قرار دادی در مطالعه، اعداد رندوم مضرب ۲، بیمار را در گروه مداخله و اعداد رندوم غیر مضرب ۲ ،بیمار در گروه کنترل قرار می داد.
نحوه نمونه گیری به طور مستمر بوده کهو کلیه بیماران مرد بستری در طول مطالعه که دارای معیارهای ورود بودند، همگی در زمان ترخیص وارد مطالعه می شدند و در صوتیکه فاقد معیارهای خروج بودند در مطالعه باقی می ماندند و بوسیله اعداد رندوم کامپیوتری (ماشین حساب) در گروه مداخله یا کنترل تخصیص داده میشدند. به صورت بلوک 4 تای تصادفی بینطور قرار دادی در مطالعه، اعداد رندوم مضرب ۲، بیمار را در گروه مداخله و اعداد رندوم غیر مضرب ۲ ،بیمار در گروه کنترل تخصیصقرار می شوندداد.
patients have no information about the kind of consultation that receive
All patients were aware that they were participating in the study and that the intervention was a form of counseling. But he did not know which group he belonged to. In this way, the members of both groups were visited by the researcher at the time of discharge and 2 months later by the follow-up of the researcher. But in the intervention group, during the researcher's visit, counseling and training were also provided. In the control group, routine nursing training was repeated during the researcher's visit and no counseling was provided.
All patients havewere aware that they were participating in the study and that the intervention was a form of counseling. But he did not know which group he belonged to. In this way, the members of both groups were visited by the researcher at the time of discharge and 2 months later by the follow-up of the researcher. But in the intervention group, during the researcher's visit, counseling and training were also provided. In the control group, routine nursing training was repeated during the researcher's visit and no information about the kind of consultation that receivecounseling was provided.
بیماران از بسته ای که دریافت می کنند اطلاع ندارند
تمام بیماران از اینکه در مطالعه شرکت می کنند واینکه مداخله نوعی مشاوره است مطلع بودند. ولی هیچ گروهی نمی دانست که در کدام گروه قرار دارد. به این صورت که اعضای هر دو گروه در زمان ترخیص توسط محقق و ۲ ماه بعد بوسیه پیگری محقق ویزیت می شدند. اما در گروه مداخله حین ویزیت محقق، مشاوره و آموزش نیز ارایه می گردید. در گروه کنترل در زمان ویزیت محقق آموزش های روتین پرستاری بازتکرار می شد و مشاوره ارایه نمی شد.
تمام بیماران از بسته ای که دریافتاینکه در مطالعه شرکت می کنند اطلاع ندارندواینکه مداخله نوعی مشاوره است مطلع بودند. ولی هیچ گروهی نمی دانست که در کدام گروه قرار دارد. به این صورت که اعضای هر دو گروه در زمان ترخیص توسط محقق و ۲ ماه بعد بوسیه پیگری محقق ویزیت می شدند. اما در گروه مداخله حین ویزیت محقق، مشاوره و آموزش نیز ارایه می گردید. در گروه کنترل در زمان ویزیت محقق آموزش های روتین پرستاری بازتکرار می شد و مشاوره ارایه نمی شد.
Secondary outcomes
#1
empty
depression
depression
empty
افسردگی
افسردگی
empty
baseline and 2 month after dischage
baseline and 2 month after dischage
empty
زمان ترخیص و 2 ماه پس از آن
زمان ترخیص و 2 ماه پس از آن
empty
DASS21 quesionaire
DASS21 quesionaire
empty
بااستفاده از پرسشنامه DASS21
بااستفاده از پرسشنامه DASS21
#2
empty
anxiety
anxiety
empty
اضطراب
اضطراب
empty
baseline and 2 month after dischage
baseline and 2 month after dischage
empty
زمان ترخیص و 2 ماه پس از آن
زمان ترخیص و 2 ماه پس از آن
empty
DASS21 quesionaire
DASS21 quesionaire
empty
بااستفاده از پرسشنامه DASS21
بااستفاده از پرسشنامه DASS21
#3
empty
stress
stress
empty
استرس
استرس
empty
baseline and 2 month after dischage
baseline and 2 month after dischage
empty
زمان ترخیص و 2 ماه پس از آن
زمان ترخیص و 2 ماه پس از آن
empty
DASS21 quesionaire
DASS21 quesionaire
empty
بااستفاده از پرسشنامه DASS21
بااستفاده از پرسشنامه DASS21
Intervention groups
#1
Intervention group: consult with discharge plan
Intervention group: Providing face-to-face counseling to the patient during discharge in 1 session for 20 minutes - In addition to face-to-face educational counseling, patients also received an educational package containing DVD videoclip and an educational brochure containing scientific information.
Intervention group: consult withProviding face-to-face counseling to the patient during discharge planin 1 session for 20 minutes - In addition to face-to-face educational counseling, patients also received an educational package containing DVD videoclip and an educational brochure containing scientific information.
گروه مداخله: دریافت بسته آموزشی حین ترخیص
گروه مداخله: ارایه مشاوره حضوری به بیمار حین ترخیص طی ۱ جلسه در مدت ۲۰ دقیقه - همچنین بیماران علاوه بر مشاوره آموزشی حضوری، بسته آموزشی حاوی دی وی دی فیلم و بروشور آموزشی حاوی اطلاعات علمی را دریافت می نمودند.
گروه مداخله: دریافتارایه مشاوره حضوری به بیمار حین ترخیص طی ۱ جلسه در مدت ۲۰ دقیقه - همچنین بیماران علاوه بر مشاوره آموزشی حضوری، بسته آموزشی حین ترخیصحاوی دی وی دی فیلم و بروشور آموزشی حاوی اطلاعات علمی را دریافت می نمودند.
#2
Control group: conventional discharge plan
Control group: Receiving the usual training program during discharge that lasted 20 minutes in 1 session and routine nursing and training information that is provided to all patients was provided to this group of patients.
Control group: conventionalReceiving the usual training program during discharge planthat lasted 20 minutes in 1 session and routine nursing and training information that is provided to all patients was provided to this group of patients.
گروه کنترل : دریافت برنامه آموزشی معمول حین ترخیص
گروه کنترل : دریافت برنامه آموزشی معمول حین ترخیص که طی ۱ جلسه بمدت ۲۰ دقیقه به طول می انجامید و اطلاعات روتین پرستاری و آموزشی معمول که به همه بیماران ارایه می شود به این دسته از بیماران ارایه می شد.
گروه کنترل : دریافت برنامه آموزشی معمول حین ترخیص که طی ۱ جلسه بمدت ۲۰ دقیقه به طول می انجامید و اطلاعات روتین پرستاری و آموزشی معمول که به همه بیماران ارایه می شود به این دسته از بیماران ارایه می شد.
Recruitment centers
#1
Name of recruitment center - English: مرکز تحقیقات دانشگاه علوم پزشکی کاشان
Name of recruitment center - Persian: Research Center of Kashan University of Medical Sciences
Full name of responsible person - English: محسن تقدسی
Full name of responsible person - Persian: Taghadsi Mohsen
Street address - English: Arctic Blvd Ravandi, Kashan University of Medical Sciences
Street address - Persian: کاشان، کیلومتر بلوار 5 قطب راوندی کاشان
City - English: kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0021
Fax:
Email: sadatinejad71@gmail.com
Web page address:
Name of recruitment center - English: Research Center of Kashan University of Medical Sciences
Name of recruitment center - Persian: مرکز تحقیقات دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Taghadsi Mohsen
Full name of responsible person - Persian: محسن تقدسی
Street address - English: Arctic Blvd Ravandi, Kashan University of Medical Sciences
Street address - Persian: کاشان، کیلومتر بلوار 5 قطب راوندی کاشان
City - English: kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0021
Fax:
Email: sadatinejad71@gmail.com
Web page address:
Name of recruitment center - English: مرکز تحقیقات دانشگاه علوم پزشکی کاشان Name of recruitment center - Persian: Research Center of Kashan University of Medical Sciences Name of recruitment center - Persian: مرکز تحقیقات دانشگاه علوم پزشکی کاشان Full name of responsible person - English: محسن تقدسیTaghadsi Mohsen Full name of responsible person - Persian: Taghadsi Mohsenمحسن تقدسی Street address - English: Arctic Blvd Ravandi, Kashan University of Medical Sciences Street address - Persian: کاشان، کیلومتر بلوار 5 قطب راوندی کاشان City - English: kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 87159/81151 Phone: +98 31 5554 0021 Fax: Email: sadatinejad71@gmail.com Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohsen Taghadosi
Full name of responsible person - Persian: محسن تقدسی
Position - English: Faculty member
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Arctic Blvd Ravandi, Kashan University of Medical Sciences
Street address - Persian: کاشان، کیلومتر بلوار 5 قطب راوندی کاشان
City - English: kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0021
Mobile: +98 913 363 4439
Fax:
Email: sadatinejad71@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohsen Taghadosi
Full name of responsible person - Persian: محسن تقدسی
Position - English: Faculty member
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Arctic Blvd Ravandi, Kashan University of Medical Sciences
Street address - Persian: کاشان، کیلومتر بلوار 5 قطب راوندی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0021
Mobile: +98 913 363 4439
Fax:
Email: sadatinejad71@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mohsen Taghadosi Full name of responsible person - Persian: محسن تقدسی Position - English: Faculty member Position - Persian: استادیار Latest degree: phd Area of specialty/work: 27 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Arctic Blvd Ravandi, Kashan University of Medical Sciences Street address - Persian: کاشان، کیلومتر بلوار 5 قطب راوندی کاشان City - English: kashanKashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 87159/81151 Phone: +98 31 5554 0021 Mobile: +98 913 363 4439 Fax: Email: sadatinejad71@gmail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Farrokhian Alireza
Full name of responsible person - Persian: علیرضا فرخیان
Position - English: Faculty member
Position - Persian: دانشیار
Latest degree: sub_specialist
Area of specialty/work: 71
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahid Beheshti Hospital, Kashan University of Medical Sciences,Arctic Blvd Ravandi, kashan, Islamic Republic of Iran
Street address - Persian: کاشان-بلوار قطب راوندی - دانشگاه علوم پزشکی کاشان - بیمارستان شهید بهشتی
City - English: kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0021
Mobile: +98 913 163 0676
Fax:
Email: farrokhian.ar@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Farrokhian Alireza
Full name of responsible person - Persian: علیرضا فرخیان
Position - English: Faculty member
Position - Persian: دانشیار
Latest degree: sub_specialist
Area of specialty/work: 71
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahid Beheshti Hospital, Kashan University of Medical Sciences,Arctic Blvd Ravandi, kashan, Islamic Republic of Iran
Street address - Persian: کاشان-بلوار قطب راوندی - دانشگاه علوم پزشکی کاشان - بیمارستان شهید بهشتی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0021
Mobile: +98 913 163 0676
Fax:
Email: farrokhian.ar@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Farrokhian Alireza Full name of responsible person - Persian: علیرضا فرخیان Position - English: Faculty member Position - Persian: دانشیار Latest degree: sub_specialist Area of specialty/work: 71 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Shahid Beheshti Hospital, Kashan University of Medical Sciences,Arctic Blvd Ravandi, kashan, Islamic Republic of Iran Street address - Persian: کاشان-بلوار قطب راوندی - دانشگاه علوم پزشکی کاشان - بیمارستان شهید بهشتی City - English: kashanKashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 87159/81151 Phone: +98 31 5554 0021 Mobile: +98 913 163 0676 Fax: Email: farrokhian.ar@gmail.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Sadatinejad Seyyed Mohsen
Full name of responsible person - Persian: سیدمحسن ساداتی نژاد
Position - English: medical student
Position - Persian: دانشجوی پزشکی
Latest degree: a_level
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahid Beheshti Hospital, Kashan University of Medical Sciences,Arctic Blvd Ravandi, kashan, Islamic Republic of Iran
Street address - Persian: کاشان-بلوار قطب راوندی - دانشگاه علوم پزشکی کاشان - بیمارستان شهید بهشتی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0021
Mobile: +98 913 364 8376
Fax:
Email: sadatinejad71@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Sadatinejad Seyyed Mohsen
Full name of responsible person - Persian: سیدمحسن ساداتی نژاد
Position - English: Medical student
Position - Persian: دانشجوی پزشکی
Latest degree: a_level
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahid Beheshti Hospital, Kashan University of Medical Sciences,Arctic Blvd Ravandi, kashan, Islamic Republic of Iran
Street address - Persian: کاشان-بلوار قطب راوندی - دانشگاه علوم پزشکی کاشان - بیمارستان شهید بهشتی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0021
Mobile: +98 913 364 8376
Fax:
Email: sadatinejad71@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Sadatinejad Seyyed Mohsen Full name of responsible person - Persian: سیدمحسن ساداتی نژاد Position - English: medicalMedical student Position - Persian: دانشجوی پزشکی Latest degree: a_level Area of specialty/work: 30 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Shahid Beheshti Hospital, Kashan University of Medical Sciences,Arctic Blvd Ravandi, kashan, Islamic Republic of Iran Street address - Persian: کاشان-بلوار قطب راوندی - دانشگاه علوم پزشکی کاشان - بیمارستان شهید بهشتی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 87159/81151 Phone: +98 31 5554 0021 Mobile: +98 913 364 8376 Fax: Email: sadatinejad71@gmail.com Web page address:
Protocol summary
Study aim
determine the effect of councelling program on sexual knowledge and quality of life and DASS21 score of patients(men) after Invasive coronary intervention
Design
This study is a clinical trial (phase 3) with a control group, with parallel groups, single-blind, randomized, on 56 patients. All male patients with inclusion and exclusion criteria were entered into the study and randomly allocated to the groups by the Rand calculator function.
Settings and conduct
In the post cath ward of Shahid Beheshti hospital in Kashan, at the time of discharge, patients were evaluated and after being allocated to study groups, the researcher provided training and counseling to patients.
Participants/Inclusion and exclusion criteria
Married male patients; aged 35-65 years; undergoing CABG and PTCA treatment; no severe physical illness, addiction, known psychiatric problem, or previous sexual dysfunction at the time of discharge.
Intervention groups
Patients who received sexual activity guidance counseling at discharge were called an intervention group, and the control group was provided with routine nursing training, and no intervantion counseling was provided.
Main outcome variables
Sexual knowledge; sexual quality of life
General information
Reason for update
adding extra secondary outcome
Acronym
IRCT registration information
IRCT registration number:IRCT20100829004655N8
Registration date:2018-03-19, 1396/12/28
Registration timing:prospective
Last update:2021-07-20, 1400/04/29
Update count:1
Registration date
2018-03-19, 1396/12/28
Registrant information
Name
Mohsen Taghadosi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
taghadosi_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
2018-04-04, 1397/01/15
Actual recruitment end date
2018-09-06, 1397/06/15
Trial completion date
2018-11-22, 1397/09/01
Scientific title
Effect of sexual counseling on knowledge, Sexual Quality of Life and DASS21 score in post CABG and PTCA patients (men)
Public title
Effect of discharge counselling on knowledge and Sexual Quality of Life and DASS21 score in patients (men)
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
patient can read and write
patient must be married and living with partner
Exclusion criteria:
heart, liver, pulmonary and kidney failure or malignancy or any systemic disease
use of antipsychotic or cytotoxic drug
severe heart failure (function class III or IV (NYHA))
alcohol or opium abuse (based on the patient statement)
existence of current depression, anxiety, stress based on DASS-21 score (depression score<10 or anxiety score<8 or stress score<15)
current known sexual dysfunction
current known psychological disorder
Age
From 35 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
45
Actual sample size reached:
56
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method was continuous, and all male patients admitted during the study who had inclusion criteria were admitted to the study at the time of discharge and remained in the study if they did not have exclusion criteria. Then they were allocated to the intervention or control group randomly by random computer numbers (calculator). Conventionally in the study, random multiple numbers 2 placed the patient in the intervention group, and non-multiple random numbers 2 placed the patient in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
All patients were aware that they were participating in the study and that the intervention was a form of counseling. But he did not know which group he belonged to. In this way, the members of both groups were visited by the researcher at the time of discharge and 2 months later by the follow-up of the researcher. But in the intervention group, during the researcher's visit, counseling and training were also provided. In the control group, routine nursing training was repeated during the researcher's visit and no counseling was provided.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
•Ethics committee of kashan University of Medical Sciences
Street address
Ghotb Ravandi Blvd, Kashan
City
kaushan
Province
Isfehan
Postal code
8715981151
Approval date
2018-01-01, 1396/10/11
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.97
Health conditions studied
1
Description of health condition studied
Chronic ischemic heart disease
ICD-10 code
I25.9
ICD-10 code description
Chronic ischemic heart disease, unspecified
Primary outcomes
1
Description
sexual knowledge
Timepoint
baseline and 2 month after dischage
Method of measurement
sexual knowledge questionnaire in cardiac patient
2
Description
sexual quality of life
Timepoint
baseline and 2 month after dischage
Method of measurement
Abraham sexual quality of life questionnaire
Secondary outcomes
1
Description
depression
Timepoint
baseline and 2 month after dischage
Method of measurement
DASS21 quesionaire
2
Description
anxiety
Timepoint
baseline and 2 month after dischage
Method of measurement
DASS21 quesionaire
3
Description
stress
Timepoint
baseline and 2 month after dischage
Method of measurement
DASS21 quesionaire
Intervention groups
1
Description
Intervention group: Providing face-to-face counseling to the patient during discharge in 1 session for 20 minutes - In addition to face-to-face educational counseling, patients also received an educational package containing DVD videoclip and an educational brochure containing scientific information.
Category
Rehabilitation
2
Description
Control group: Receiving the usual training program during discharge that lasted 20 minutes in 1 session and routine nursing and training information that is provided to all patients was provided to this group of patients.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center of Kashan University of Medical Sciences
Full name of responsible person
Taghadsi Mohsen
Street address
Arctic Blvd Ravandi, Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
sadatinejad71@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidi Gholamali
Street address
Arctic Blvd Ravandi, Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
sadatinejad71@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghadosi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arctic Blvd Ravandi, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
sadatinejad71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Farrokhian Alireza
Position
Faculty member
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shahid Beheshti Hospital, Kashan University of Medical Sciences,Arctic Blvd Ravandi, kashan, Islamic Republic of Iran
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
farrokhian.ar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sadatinejad Seyyed Mohsen
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahid Beheshti Hospital, Kashan University of Medical Sciences,Arctic Blvd Ravandi, kashan, Islamic Republic of Iran
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
sadatinejad71@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only available to scholars working in academia and academia.
Under which criteria data/document could be used
If you observe the trust and mention the source, data is available for researchers.
From where data/document is obtainable
Send the following e-mail to the following address: taghadosi_m@kaums.ac.ir
What processes are involved for a request to access data/document
After receiving the letter via email, your request will be reviewed within 2 weeks and the data will be sent to the applicant at the discretion.