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Protocol summary
این مطالعه یک کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سو کور، تصادفی شده، بر روی 60 بیمار میباشند. پس از بررسی معیار های ورود و خروج، بیماران واجد شرایط با استفاده از روش تصادفی بلوکی 4 تایی به دو گروه 30 تایی تخصیص خواهند یافت.
این مطالعه یک کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، یک سو کور، تصادفی شده، بر روی 60 بیمار میباشند. پس از بررسی معیار های ورود و خروج، بیماران واجد شرایط با استفاده از روش تصادفی بلوکی 4 تایی به دو گروه 30 تایی تخصیص خواهند یافت.
این مطالعه یک کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، یک سو کور، تصادفی شده، بر روی 60 بیمار میباشند. پس از بررسی معیار های ورود و خروج، بیماران واجد شرایط با استفاده از روش تصادفی بلوکی 4 تایی به دو گروه 30 تایی تخصیص خواهند یافت.
General information
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Updating the publication schedule for printing the protocol study article.
Updating the publication schedule for printing the protocol study article.
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بروزرسانی برنامه انتشار جهت چاپ مقاله پروتکل
بروزرسانی برنامه انتشار جهت چاپ مقاله پروتکل
having an on-pump coronary bypass surgery
being on the elective coronary artery bypass surgery list
experiencing Heart surgery for the first time
ability to speak and understand Persian
not having diagnosed with anxiety or other psychological disorders (self-report)
non-concurrency of CABG surgery with valve replacement or other surgeries
Having an on-pump coronary bypass surgery
Being on the elective coronary artery bypass surgery list
Experiencing Heart surgery for the first time
Ability to speak and understand Persian
Not having diagnosed with anxiety or other psychological disorders (self-report)
Non-concurrency of CABG surgery with valve replacement or other surgeries
havingHaving an on-pump coronary bypass surgery beingBeing on the elective coronary artery bypass surgery list experiencingExperiencing Heart surgery for the first time abilityAbility to speak and understand Persian notNot having diagnosed with anxiety or other psychological disorders (self-report) nonNon-concurrency of CABG surgery with valve replacement or other surgeries
Health conditions studied
#1
ischemic heart disease
Ischemic heart disease
ischemicIschemic heart disease
Primary outcomes
#1
duration of stay in the hospital
Duration of stay in the hospital
durationDuration of stay in the hospital
#2
duration of stay in intensive care unit
Duration of stay in intensive care unit
durationDuration of stay in intensive care unit
#3
duration of intubation time
Duration of intubation time
durationDuration of intubation time
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Pouya Dolat Abadi
Full name of responsible person - Persian: پویا دولت آبادی
Position - English: Master of Sciences Studnet
Position - Persian: دانشجوی کارشناسی ارشد
Latest degree: master
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 1, 4th floor, Vaziri Ave, South Kargat st, Tehran, Tehran, Iran, Postal code: 1339753453
Street address - Persian: خ کارگر جنوبی - پایین تر از مختاری - کوچه وزیری - پلاک 1 واحد 4 - کد پستی 1339753453
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1339753453
Phone: +98 45 3353 4493
Mobile: +98 938 070 9579
Fax:
Email: dolatabadi-p@razi.tums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Pouya Dolat Abadi
Full name of responsible person - Persian: پویا دولت آبادی
Position - English: Master of Sciences Studnet
Position - Persian: دانشجوی کارشناسی ارشد
Latest degree: master
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 1, 4th floor, Vaziri Ave, South Kargat st, Tehran, Tehran, Iran, Postal code: 1339753453
Street address - Persian: خ کارگر جنوبی، پایین تر از مختاری، کوچه وزیری، پلاک 1، واحد 4، کد پستی 1339753453
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1339753453
Phone: +98 45 3353 4493
Mobile: +98 938 070 9579
Fax:
Email: dolatabadi-p@razi.tums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Pouya Dolat Abadi Full name of responsible person - Persian: پویا دولت آبادی Position - English: Master of Sciences Studnet Position - Persian: دانشجوی کارشناسی ارشد Latest degree: master Area of specialty/work: 27 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No 1, 4th floor, Vaziri Ave, South Kargat st, Tehran, Tehran, Iran, Postal code: 1339753453 Street address - Persian: خ کارگر جنوبی -، پایین تر از مختاری -، کوچه وزیری -، پلاک 1، واحد 4 -، کد پستی 1339753453 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1339753453 Phone: +98 45 3353 4493 Mobile: +98 938 070 9579 Fax: Email: dolatabadi-p@razi.tums.ac.ir Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Pouya Dolat Abadi
Full name of responsible person - Persian: پویا دولت آبادی
Position - English: Master of Sciences Studnet
Position - Persian: دانشجوی کارشناسی ارشد
Latest degree: master
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 1, 4th floor, Vaziri Ave, South Kargat st, Tehran, Tehran, Iran, Postal code: 1339753453
Street address - Persian: خ کارگر جنوبی - پایین تر از مختاری - کوچه وزیری - پلاک 1 واحد 4 - کد پستی 1339753453
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1339753453
Phone: +98 45 3353 4493
Mobile: +98 938 070 9579
Fax:
Email: dolatabadi-p@razi.tums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Pouya Dolat Abadi
Full name of responsible person - Persian: پویا دولت آبادی
Position - English: Master of Sciences Studnet
Position - Persian: دانشجوی کارشناسی ارشد
Latest degree: master
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 1, 4th floor, Vaziri Ave, South Kargat st, Tehran, Tehran, Iran, Postal code: 1339753453
Street address - Persian: خ کارگر جنوبی، پایین تر از مختاری، کوچه وزیری، پلاک 1، واحد 4، کد پستی 1339753453
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1339753453
Phone: +98 45 3353 4493
Mobile: +98 938 070 9579
Fax:
Email: dolatabadi-p@razi.tums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Pouya Dolat Abadi Full name of responsible person - Persian: پویا دولت آبادی Position - English: Master of Sciences Studnet Position - Persian: دانشجوی کارشناسی ارشد Latest degree: master Area of specialty/work: 27 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No 1, 4th floor, Vaziri Ave, South Kargat st, Tehran, Tehran, Iran, Postal code: 1339753453 Street address - Persian: خ کارگر جنوبی -، پایین تر از مختاری -، کوچه وزیری -، پلاک 1، واحد 4 -، کد پستی 1339753453 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1339753453 Phone: +98 45 3353 4493 Mobile: +98 938 070 9579 Fax: Email: dolatabadi-p@razi.tums.ac.ir Web page address:
Sharing plan
undecided
yes
undecidedyes
undecided
yes
undecidedyes
undecided
yes
undecidedyes
undecided
yes
undecidedyes
undecided
yes
undecidedyes
The decision will be made according to the opinion of the university and the supervisor.
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The decision will be made according to the opinion of the university and the supervisor.
طبق نظر دانشگاه و استاد راهنما تصمیم گیری خواهد شد.
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طبق نظر دانشگاه و استاد راهنما تصمیم گیری خواهد شد.
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The data includes demographic information (such as age and gender), discharge readiness, duration of intubation, ICU stay, occurrence of atelectasis, onset of mobility, hospital stay, and levels of anxiety and depression. Additionally, data related to the 30-day readmission rate have been collected. All individual participant data will be processed through anonymization prior to sharing to ensure the privacy of individuals is protected. However, due to the sensitivity of the data and ethical considerations, only a portion of the data, particularly information related to primary outcomes (such as discharge readiness), will be available for public sharing. More sensitive data, such as detailed demographic information or specific clinical details, will only be provided to authorized researchers for specific research purposes with official permission.
The data includes demographic information (such as age and gender), discharge readiness, duration of intubation, ICU stay, occurrence of atelectasis, onset of mobility, hospital stay, and levels of anxiety and depression. Additionally, data related to the 30-day readmission rate have been collected. All individual participant data will be processed through anonymization prior to sharing to ensure the privacy of individuals is protected. However, due to the sensitivity of the data and ethical considerations, only a portion of the data, particularly information related to primary outcomes (such as discharge readiness), will be available for public sharing. More sensitive data, such as detailed demographic information or specific clinical details, will only be provided to authorized researchers for specific research purposes with official permission.
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داده‌ها شامل اطلاعات دموگرافیک (مانند سن و جنسیت)، آمادگی برای ترخیص، مدت زمان لوله‌گذاری (اینتوباسیون)، مدت اقامت در ICU، وقوع آتلکتازی، زمان شروع تحرک، مدت بستری در بیمارستان و سطوح اضطراب و افسردگی میباشد. همچنین داده‌های مرتبط با نرخ پذیرش مجدد 30 روزه، جمع‌آوری شده است. تمامی داده‌های فردی شرکت‌کنندگان پیش از اشتراک‌گذاری با فرآیند غیرقابل‌شناسایی‌سازی پردازش خواهند شد تا حریم خصوصی افراد حفظ شود. با این حال، به دلیل حساسیت داده‌ها و ملاحظات اخلاقی، تنها بخشی از داده‌ها، به‌ویژه اطلاعات مربوط به پیامدهای اصلی (مانند آمادگی برای ترخیص) برای اشتراک‌گذاری عمومی در دسترس خواهد بود. داده‌های حساس‌تر، مانند اطلاعات دموگرافیک کامل یا جزئیات بالینی خاص، صرفاً با مجوز رسمی و برای اهداف تحقیقاتی مشخص در اختیار محققان معتبر قرار خواهد گرفت.
داده‌ها شامل اطلاعات دموگرافیک (مانند سن و جنسیت)، آمادگی برای ترخیص، مدت زمان لوله‌گذاری (اینتوباسیون)، مدت اقامت در ICU، وقوع آتلکتازی، زمان شروع تحرک، مدت بستری در بیمارستان و سطوح اضطراب و افسردگی میباشد. همچنین داده‌های مرتبط با نرخ پذیرش مجدد 30 روزه، جمع‌آوری شده است. تمامی داده‌های فردی شرکت‌کنندگان پیش از اشتراک‌گذاری با فرآیند غیرقابل‌شناسایی‌سازی پردازش خواهند شد تا حریم خصوصی افراد حفظ شود. با این حال، به دلیل حساسیت داده‌ها و ملاحظات اخلاقی، تنها بخشی از داده‌ها، به‌ویژه اطلاعات مربوط به پیامدهای اصلی (مانند آمادگی برای ترخیص) برای اشتراک‌گذاری عمومی در دسترس خواهد بود. داده‌های حساس‌تر، مانند اطلاعات دموگرافیک کامل یا جزئیات بالینی خاص، صرفاً با مجوز رسمی و برای اهداف تحقیقاتی مشخص در اختیار محققان معتبر قرار خواهد گرفت.
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Access period begins after results are printed.
Access period begins after results are printed.
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شروع دوره دسترسی پس از چاپ نتایج میباشد.
شروع دوره دسترسی پس از چاپ نتایج میباشد.
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We have a rigorous process in place to ensure that only qualified researchers who are affiliated with academic or research institutions and who can demonstrate their qualifications and data protection measures are given access. This access is exclusively for research purposes, safeguarding the integrity and security of our data.
We have a rigorous process in place to ensure that only qualified researchers who are affiliated with academic or research institutions and who can demonstrate their qualifications and data protection measures are given access. This access is exclusively for research purposes, safeguarding the integrity and security of our data.
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ما یک فرآیند سختگیرانه داریم تا اطمینان حاصل کنیم که تنها به پژوهشگران واجد شرایطی که وابسته به موسسات آکادمیک یا پژوهشی هستند و می‌توانند صلاحیت‌های خود و اقدامات حفاظت از داده را نشان دهند، دسترسی داده می‌شود. این دسترسی صرفاً برای اهداف پژوهشی اعطا می‌شود و بدین وسیله از یکپارچگی و امنیت داده‌های ما محافظت می‌شود.
ما یک فرآیند سختگیرانه داریم تا اطمینان حاصل کنیم که تنها به پژوهشگران واجد شرایطی که وابسته به موسسات آکادمیک یا پژوهشی هستند و می‌توانند صلاحیت‌های خود و اقدامات حفاظت از داده را نشان دهند، دسترسی داده می‌شود. این دسترسی صرفاً برای اهداف پژوهشی اعطا می‌شود و بدین وسیله از یکپارچگی و امنیت داده‌های ما محافظت می‌شود.
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Data access is limited to research matching the study's goals and ethics. Researchers must sign an agreement banning re-identification and detailing non-commercial use. Analyses may need approval; publications require pre-approval for data integrity. Documents are restricted to related research per the agreement.
Data access is limited to research matching the study's goals and ethics. Researchers must sign an agreement banning re-identification and detailing non-commercial use. Analyses may need approval; publications require pre-approval for data integrity. Documents are restricted to related research per the agreement.
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دسترسی به داده‌ها تنها برای پژوهش‌هایی مجاز است که با اهداف اصلی مطالعه و مجوزهای اخلاقی آن هم‌راستا باشند. این امر تضمین می‌کند که استفاده از داده‌ها در چارچوب مقاصد تعیین‌شده باقی بماند. پژوهشگران ملزم به امضای توافق‌نامه‌ای هستند که استفاده‌های مجاز از داده‌ها را مشخص کرده و هرگونه تلاش برای شناسایی مجدد افراد را صراحتاً ممنوع می‌کند. تحلیل‌هایی که بر روی داده‌های تحویل‌شده انجام می‌شود، باید صرفاً برای اهداف غیرتجاری باشد. همچنین، ممکن است لازم باشد که نوع تحلیل‌ها پیش از انجام، مورد تأیید قرار گیرد تا از انطباق با شرایط تعیین‌شده اطمینان حاصل شود. هرگونه انتشار نتایج یا اشتراک‌گذاری یافته‌ها باید پیش از انجام، توسط نهاد مسئول بررسی و تأیید شود. این امر به منظور حفاظت از یکپارچگی داده‌ها و جلوگیری از سوءاستفاده صورت می‌گیرد.
مستندات تنها برای اهداف پژوهشی مرتبط با داده‌ها قابل استفاده هستند و نمی‌توان از آن‌ها برای مقاصد تجاری یا غیرمرتبط بهره‌برداری کرد. همچنین، هرگونه استفاده باید با توافق‌نامه امضاشده هم‌راستا باشد.
دسترسی به داده‌ها تنها برای پژوهش‌هایی مجاز است که با اهداف اصلی مطالعه و مجوزهای اخلاقی آن هم‌راستا باشند. این امر تضمین می‌کند که استفاده از داده‌ها در چارچوب مقاصد تعیین‌شده باقی بماند. پژوهشگران ملزم به امضای توافق‌نامه‌ای هستند که استفاده‌های مجاز از داده‌ها را مشخص کرده و هرگونه تلاش برای شناسایی مجدد افراد را صراحتاً ممنوع می‌کند. تحلیل‌هایی که بر روی داده‌های تحویل‌شده انجام می‌شود، باید صرفاً برای اهداف غیرتجاری باشد. همچنین، ممکن است لازم باشد که نوع تحلیل‌ها پیش از انجام، مورد تأیید قرار گیرد تا از انطباق با شرایط تعیین‌شده اطمینان حاصل شود. هرگونه انتشار نتایج یا اشتراک‌گذاری یافته‌ها باید پیش از انجام، توسط نهاد مسئول بررسی و تأیید شود. این امر به منظور حفاظت از یکپارچگی داده‌ها و جلوگیری از سوءاستفاده صورت می‌گیرد. مستندات تنها برای اهداف پژوهشی مرتبط با داده‌ها قابل استفاده هستند و نمی‌توان از آن‌ها برای مقاصد تجاری یا غیرمرتبط بهره‌برداری کرد. همچنین، هرگونه استفاده باید با توافق‌نامه امضاشده هم‌راستا باشد.
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Data can be accessed by contacting the corresponding author via provided email.
Data can be accessed by contacting the corresponding author via provided email.
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با تماس با نویسنده مسئول از طریق ایمیل ارائه شده می توان به داده ها دسترسی داشت.
با تماس با نویسنده مسئول از طریق ایمیل ارائه شده می توان به داده ها دسترسی داشت.
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Data can be accessed by contacting the corresponding author via provided email. The response is expected to be provided within two weeks.
Data can be accessed by contacting the corresponding author via provided email. The response is expected to be provided within two weeks.
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با تماس با نویسنده مسئول از طریق ایمیل ارائه شده می توان به داده ها دسترسی داشت. پاسخ تا نهایتا دو هفته ارسال خواهد شد.
با تماس با نویسنده مسئول از طریق ایمیل ارائه شده می توان به داده ها دسترسی داشت. پاسخ تا نهایتا دو هفته ارسال خواهد شد.
Protocol summary
Study aim
Assessing effect of the prehabilitation program on discharge readiness and post-surgery outcomes in patients undergoing CABG surgery
Design
This study is a randomised clinical trial with a control group, with parallel groups, blinded outcome assesment on 60 patients. After checking the inclusion and exclusion criteria, the eligible patients will be assigned to two groups using a random 4 blocks method.
Settings and conduct
Participants will be randomly divided into intervention and control groups. The control group will receive standard care, while patients in the intervention group will receive the nurse-led prehabilitation program including respiratory muscle strengthening exercises, preoperative nutritional guidance, and stress management techniques. In this study, data analysts are blinded to the placement of patients in the intervention or control group.
Participants/Inclusion and exclusion criteria
Inclusion criatria are having an on-pump coronary bypass surgery, being on the elective coronary artery bypass surgery list, experiencing Heart surgery for the first time, ability to speak and understand Persian, not having diagnosed with anxiety or other psychological disorders (self-report), non-concurrency of CABG surgery with other surgeries. Exclusion criterias are History of cerebrovascular disease and/or stroke, Previous heart or lung surgery or disesases, Presence of neuromuscular disorder, and Patients with cognitive disorders and/or Alzheimer's disease
Intervention groups
The patients with a diagnosis of coronary artery disesase referred to IKHC cardiac surgery clinic will be screened for the eligibility criteria.
Main outcome variables
The patients' discharge readiness assessed by nurse and the patient, anxiety and depression before surgery and before discharge, length of stay in the hospital and intensive care unit, duration of intubation.
General information
Reason for update
Updating the publication schedule for printing the protocol study article.
Acronym
PreCABG
IRCT registration information
IRCT registration number:IRCT20231019059768N1
Registration date:2024-05-23, 1403/03/03
Registration timing:prospective
Last update:2025-04-02, 1404/01/13
Update count:1
Registration date
2024-05-23, 1403/03/03
Registrant information
Name
Pouya Dolat Abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3353 4493
Email address
dolatabadi-p@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-30, 1403/03/10
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of prehabilitation program on discharge readiness and surgery outcomes in patients going on a coronoray artery bypass Graft
Public title
prehabilitation in patients going on a coronoray artery bypass Graft
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having an on-pump coronary bypass surgery
Being on the elective coronary artery bypass surgery list
Experiencing Heart surgery for the first time
Ability to speak and understand Persian
Not having diagnosed with anxiety or other psychological disorders (self-report)
Non-concurrency of CABG surgery with valve replacement or other surgeries
Exclusion criteria:
Emergency surgery
History of cerebrovascular disease and/or stroke
Previous heart or lung surgery
Presence of neuromuscular disorder
Previous COPD disease
Vulvar diseases
Patients with cognitive disorders and/or Alzheimer's disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be selected by continuous sampling and the patients will be placed in two groups of control and case by Block Balanced Randomization (BBR). By using the free website http://www.randomization.com/, the assignment sequence will take place. In such a way that the number of subjects in each block will be set to 6, for the control group letter A and for the case group, the letter B will be considered, and finally, by approving the Randomization Sequence in the system for 10 blocks, The assignment sequence will be created for the 60 samples by combining the letters A and B. Finally, the cards containing the blocks will be placed inside the standard envelope, and as a result, allocation concealment will be considered and observed. Based on qualified samples, a Shuffling Envelope will be taken by the researcher accidentally. Finally, the random allocation method will be determined by the research samples.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, data analysts are blinded to the placement of patients in the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research of Imam Khomeini Hospital Complex (RA)
Score of patients' Discharge readiness assessed by Nurse
Timepoint
Immediately after making discision to discharge the patient
Method of measurement
According to readiness for hospital discharge scale RN assessment short form
2
Description
Score of patients' Discharge readiness by patient
Timepoint
Immediately after making discision to discharge the patient
Method of measurement
According to readiness for hospital discharge scale short form
3
Description
Anxiety score in hospital anxiety and depression scale (HADS)
Timepoint
At the beginning of the study (before the start of the intervention), and the night before the surgery, and immediately after making discision to discharge the patient.
Method of measurement
Hospital anxiety and depression scale (HADS)
4
Description
Depression score in hospital anxiety and depression scale (HADS)
Timepoint
At the beginning of the study (before the start of the intervention), and the night before the surgery, and immediately after making discision to discharge the patient.
Method of measurement
Hospital anxiety and depression scale (HADS)
5
Description
Duration of stay in the hospital
Timepoint
After patient's dicharge
Method of measurement
Based on the duration of hospitalization documented in the patient's files
6
Description
Duration of stay in intensive care unit
Timepoint
After patient's dicharge
Method of measurement
Based on the duration of stay in the intensive care unit documented in the patient's files
7
Description
Duration of intubation time
Timepoint
After patient's dicharge
Method of measurement
Based on the duration of intubation time documented in the patient's files
Secondary outcomes
empty
Intervention groups
1
Description
This intervention includes 1) communication between the researcher nurse and the patient 2) a general explanation about the surgical procedure in a way that does not cause anxiety 3) encouraging the patient to talk about his/her concerns and their causes and correcting the patient's inappropriate thoughts 4) introduction Stress management methods that include progressive muscle relaxation, deep breathing, and guided imagery and then teaching and practicing the preferred method to the patient. 5) Providing recommendations related to the type of nutrition before the operation, including consuming fewer carbohydrates, and consuming more foods containing protein, vitamins, and micronutrients. 6) Advising to quit smoking if needed and teaching exercises related to strengthening the respiratory muscles, such as using the pursed-lip breathing method to the patient and practicing these methods until the exercises are performed correctly by the patient. In this way, the eligible samples in the heart surgery clinic will be selected, and after obtaining informed consent; a demographic information questionnaire, hospital anxiety and depression scale, and Duke physical activity scale will be completed by volunteers. In the case of the test group, considering that heart surgery patients enter the study about 7 days before the surgery, the researcher starts his intervention one week before the surgery. In the first session, face-to-face training will take place in the heart surgery clinic, and at the same time, a complete Prehabilitation booklet will be provided to the patient. The second and third sessions will be held in the afternoon (between 16:00 and 18:00) in the patient's heart surgery department. In the second and third sessions of the intervention, while reviewing the teachings discussed in the first session, the patient is encouraged to raise issues that occupy his mind, the researcher answers the patient's questions, and then the patient's preferred stress management method and breathing exercises are performed. Each session lasts about 45 to 60 minutes based on the patient's needs. In the case of both control and test groups, routine care including drug therapy and hemodynamic control of the patient is performed. On the day of surgery, the hospital anxiety and depression scale questionnaire will be filled again by the patient. On the morning of the discharge, the hospital anxiety and depression scale and the discharge readiness questionnaire are filled by the patient. Also, the discharge readiness questionnaire from the nurse's point of view is completed by his/her direct nurse. The checklist including the length of stay in the ICU, the length of intubation, the length of stay in the hospital, the approximate time of the patient's mobility, and the observation of atelectasis (according to the doctor's diagnosis) will be completed by the researcher. Also, after 30 days, the patient will be contacted and asked about re-hospitalization and the patient will be asked to complete Duke's physical activity questionnaire that was given to him on the day of discharge and send it to the researcher through messengers.
Category
Rehabilitation
2
Description
The control group will receive routine care including drug therapy and hemodynamic monitoring. The eligible samples in the heart surgery clinic will be selected, and after obtaining informed consent; a demographic information questionnaire, hospital anxiety and depression scale, and Duke physical activity scale will be completed. On the day of surgery, the hospital anxiety and depression scale questionnaire will be filled again by the patient. On the morning of the discharge, the hospital anxiety and depression scale and the discharge readiness questionnaire are filled by the patient. Also, the discharge readiness questionnaire from the nurse's point of view is completed by his/her direct nurse. The checklist including the length of stay in the ICU, the length of intubation, the length of stay in the hospital, the approximate time of the patient's mobility, and the observation of atelectasis (according to the doctor's diagnosis) will be completed by the researcher. Also, after 30 days, the patient will be contacted and asked about re-hospitalization and the patient will be asked to complete Duke's physical activity questionnaire that was given to him on the day of discharge and send it to the researcher through messengers.
Keshavarz Blvd., corner of Quds St., Tehran University of Medical Sciences Central Building , 6th floor
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Pouya Dolat Abadi
Position
Master of Sciences Studnet
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 1, 4th floor, Vaziri Ave, South Kargat st, Tehran, Tehran, Iran, Postal code: 1339753453
City
Tehran
Province
Tehran
Postal code
1339753453
Phone
+98 45 3353 4493
Fax
Email
dolatabadi-p@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pouya Dolat Abadi
Position
Master of Sciences Studnet
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 1, 4th floor, Vaziri Ave, South Kargat st, Tehran, Tehran, Iran, Postal code: 1339753453
City
Tehran
Province
Tehran
Postal code
1339753453
Phone
+98 45 3353 4493
Fax
Email
dolatabadi-p@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pouya Dolat Abadi
Position
Master of Sciences Studnet
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 1, 4th floor, Vaziri Ave, South Kargat st, Tehran, Tehran, Iran, Postal code: 1339753453
City
Tehran
Province
Tehran
Postal code
1339753453
Phone
+98 45 3353 4493
Fax
Email
dolatabadi-p@razi.tums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data includes demographic information (such as age and gender), discharge readiness, duration of intubation, ICU stay, occurrence of atelectasis, onset of mobility, hospital stay, and levels of anxiety and depression. Additionally, data related to the 30-day readmission rate have been collected. All individual participant data will be processed through anonymization prior to sharing to ensure the privacy of individuals is protected. However, due to the sensitivity of the data and ethical considerations, only a portion of the data, particularly information related to primary outcomes (such as discharge readiness), will be available for public sharing. More sensitive data, such as detailed demographic information or specific clinical details, will only be provided to authorized researchers for specific research purposes with official permission.
When the data will become available and for how long
Access period begins after results are printed.
To whom data/document is available
We have a rigorous process in place to ensure that only qualified researchers who are affiliated with academic or research institutions and who can demonstrate their qualifications and data protection measures are given access. This access is exclusively for research purposes, safeguarding the integrity and security of our data.
Under which criteria data/document could be used
Data access is limited to research matching the study's goals and ethics. Researchers must sign an agreement banning re-identification and detailing non-commercial use. Analyses may need approval; publications require pre-approval for data integrity. Documents are restricted to related research per the agreement.
From where data/document is obtainable
Data can be accessed by contacting the corresponding author via provided email.
What processes are involved for a request to access data/document
Data can be accessed by contacting the corresponding author via provided email. The response is expected to be provided within two weeks.