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Assesment the effect of visiting based on developed protocol on physiologic parameters and delirium in patient hospitslized in ICU

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History
# Registration date Revision Id
2 2025-10-08, 1404/07/16 358424
1 2018-01-25, 1396/11/05 34588
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  • Protocol summary

    This study is a single- blind clinical trial. The research population is patients admitted to internal intensive care units of public hospitals of Mashhad who are over 18 years of age and have a full knowledge of Persian language, relative alertness and ability to communicate verbally or non verbally. Sampling will be done through available sampling and the first sample will be placed randomly in the test or control group. Sampling for the other group will not be performed until the patients in the first selection group are present, and after the discharge of these patients, sampling will be done for the next group. This will continue to complete the sampling for the two groups. In the control group the visinting will be done in the routin way in intensive care unit. In the test group, the visiting will be done in accordance with the protocol. This protocol includes the appointment of a visitor, training him on how to meet and control the correct conduct of the visit. Physiological parameters include systolic and diastolic blood pressure, heart rate, respiratory rate and hemoglobin saturation from oxygen before, during and immediately after each visit, and delirium using the "Confounding Scale of Nellon and Champaigne" at the beginning of the study and in the first, second and third days after starting the study, will be completed for patients in both groups. Finally, data will be analyzed using the statistical software.
    This study is a single- blind clinical trial. The research population is patients admitted to internal intensive care units of public hospitals of Mashhad who are over 18 years of age and have a full knowledge of Persian language, relative alertness and ability to communicate verbally or non verbally.
    این مطالعه، کارآزمایی بالینی یک سو کور است که جامعه پژوهش آن بیماران بستری در بخشهای مراقبت ویژه داخلی بیمارستانهای دولتی مشهد میباشد که دارای سن بالای 18 سال و آشنایی کامل به زبان فارسی، هوشیار ی نسبی و توانایی ارتباط کلامی یا غیر کلامی باشند. نمونه گیری در این مطالعه به صورت در دسترس خواهد بود و اولین نمونه با استفاده از تخصیص تصادفی در گروه آزمون یا شاهد قرار داده خواهد شد. تا زمانیکه بیماران گروه انتخابی اول، در بخش حضور داشته باشند نمونه گیری برای گروه دیگر صورت نخواهد گرفت و با ترخیص این بیماران نمونه گیری برای گروه بعدی انجام خواهد شد. این کار تا تکمیل نمونه گیری برای دو گروه ادامه خواهد یافت. در گروه شاهد، ملاقات به روش معمول در بخش های ویژه، انجام خواهد شد. در گروه آزمون، ملاقات طبق پروتکل اجرا خواهد گردید. این پرونوکل شامل تعیین فرد ملاقات کننده، اموزش به وی در مورد نحوه ملاقات و کنترل اجرای صحیح ملاقات خواهد بود. معیارهای فیزیولوژیک شامل: فشارخون سیستولیک و دیاستولیک- ضربان قلب- تعداد تنفس و میزان اشباع هموگلوبین از اکسیژن، قبل، حین و بلافاصله بعد از هر ملاقات و دلیریوم با استفاده از"مقياس کنفوزيون نلون و چمپاگن"در ابتدای مطالعه و در روز های اول، دوم و سوم بعد از شروع مطالعه، برای بیماران هر دو گروه، تکمیل خواهد شد. در پایان داده ها با استفاده از نرم افزار آماری مورد تجزیه و تحلیل قرار خواهد گرفت.
    این مطالعه، کارآزمایی بالینی یک سو کور است که جامعه پژوهش آن بیماران بستری در بخشهای مراقبت ویژه داخلی بیمارستانهای دولتی مشهد میباشد که دارای سن بالای 18 سال و آشنایی کامل به زبان فارسی، هوشیار ی نسبی و توانایی ارتباط کلامی یا غیر کلامی باشند.

  • General information

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    2019-02-09, 1397/11/20
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    2018-01-26, 1396/11/06
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    2019-02-09, 1397/11/20
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    Sampling dates information has been corrected.
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    اطلاعات تاریخ های نمونه گیری اصلاح شد
    Random Tool: Use Random Number Tables
    ابزار تصادفی: استفاده از جدول اعداد تصادفی
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  • Recruitment centers

    #1
    Name of recruitment center - English: Imam reza hospital
    Name of recruitment center - Persian: بیمارستان امام رضا(ع)
    Full name of responsible person - English: Zahra Nazari Ostad
    Full name of responsible person - Persian: زهرا نظری استاد
    Street address - English: Nursing & Midwifery school, Daneshgah Street, Masshad- Iran
    Street address - Persian: دانشکده ی پرستاری و مامایی مشهد- خیابان دانشگاه- مشهد- ایران
    City - English: Masshad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 99191-91778
    Phone: +98 51 3859 1511
    Fax:
    Email: nazariz1@mums.ac.ir
    Web page address:
    Name of recruitment center - English: Imam Reza Hospital
    Name of recruitment center - Persian: بیمارستان امام رضا(ع)
    Full name of responsible person - English: Zahra Nazari Ostad
    Full name of responsible person - Persian: زهرا نظری استاد
    Street address - English: Nursing and Midwifery school, Daneshgah Street, Masshad, Iran
    Street address - Persian: دانشکده ی پرستاری و مامایی مشهد- خیابان دانشگاه- مشهد- ایران
    City - English: Masshad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 99191-91778
    Phone: +98 51 3859 1511
    Fax:
    Email: nazariz1@mums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: fateme hajiabadi
    Full name of responsible person - Persian: فاطمه حاجی آبادی
    Street address - English: Nursing & Midwifery school- Daneshgah street- Mashhad-
    Street address - Persian: مشهد- خیابان دانشگاه - دانشگاه علوم پزشکی مشهد دانشکده پرستاری و مامایی
    City - English: Masshad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 99191-91778
    Phone: +98 51 3859 1511
    Fax:
    Email: Hajiabadif@mums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fateme Hajiabadi
    Full name of responsible person - Persian: فاطمه حاجی آبادی
    Street address - English: Nursing and Midwifery School, Daneshgah Street, Mashhad
    Street address - Persian: مشهد, خیابان دانشگاه دانشگاه علوم پزشکی مشهد دانشکده پرستاری و مامایی
    City - English: Masshad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 99191-91778
    Phone: +98 51 3859 1511
    Fax:
    Email: Hajiabadif@mums.ac.ir
    Web page address:

Protocol summary

Study aim
Determination the effect of visiting based on Developed Protocol on Physiological Parameters and Delirium of Patients Admitted to Intensive Care Unit
Design
This study is a single- blind clinical trial. The research population is patients admitted to internal intensive care units of public hospitals of Mashhad who are over 18 years of age and have a full knowledge of Persian language, relative alertness and ability to communicate verbally or non verbally.
Settings and conduct
A clinical trial study will be carried out blindly in Imam Reza Hospital in Mashhad, so that the Delirium evaluator will not be aware of the allocation of patients to the control or intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria : The patients should be satisfied to participate in the study. They should be hospitalized in ICU. They should have the ability to communicate verbally or non-verbally. Their age should be 18-70 years. Hemodynamic stability at least 30 minutes prior to the measurment related to the study Not getting known mental illness GCS score is between 11 and 15 Exclusion criteria: Unwillingness to continue participating in the study. The lack of collaboration of the family of patients. Starting the drugs that affect on the measures of the criteria at the beginning and during the study period
Intervention groups
The intervention group are patients hospitalized in Imam Reza Hospital, Mashhad, Iran that visiting will be conducted in accordance with the protocol. The control group also includes patients similar to the intervention group that visiting will done in routine.
Main outcome variables
Physiological Indices and Arterial Oxygen Saturation and Delirium

General information

Reason for update
Sampling dates information has been corrected.
Acronym
IRCT registration information
IRCT registration number: IRCT20161229031654N2
Registration date: 2018-01-25, 1396/11/05
Registration timing: prospective

Last update: 2025-10-09, 1404/07/17
Update count: 1
Registration date
2018-01-25, 1396/11/05
Registrant information
Name
zahra nazari ostad
Name of organization / entity
masshad university of medical sience
Country
Iran (Islamic Republic of)
Phone
+98 51 3276 5809
Email address
nazariz1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research os masshad university of medical sience
Expected recruitment start date
2018-01-26, 1396/11/06
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
2018-01-26, 1396/11/06
Actual recruitment end date
2019-02-09, 1397/11/20
Trial completion date
2019-02-09, 1397/11/20
Scientific title
Assesment the effect of visiting based on developed protocol on physiologic parameters and delirium in patient hospitslized in ICU
Public title
Effect of visiting based on designed protocol on physiologic parameters and delirium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study Ability to communicate verbally or non-verbally Age of 18-70 Hemodynamic stability at the start of the study Not getting known mental illness The patient's GCS score 11 to 15 Familiarities with Persian language
Exclusion criteria:
Unwillingness to continue participating in the study Non-cooperation of the family of patients Starting medications that affect on indices
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 84
Actual sample size reached: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the person assessing the delirium questionnaire did not know about the allocation of patients to the control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ettiic Committe of Masshad Unverity of Medical Siences
Street address
Daneshgah street, Masshad Unverity Of Medical Sience, Masshad
City
Masshad
Province
Razavi Khorasan
Postal code
99191-91778
Approval date
2016-12-07, 1395/09/17
Ethics committee reference number
ir.mums.rec.1395.477

Health conditions studied

1

Description of health condition studied
Relationship of the visiting based on developed protocol on the physiological parameters and delirium of patients admitted to the intensive care unit.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Physiological parameters and delerium
Timepoint
In the beginning of the study and on the first, second and third day after the start of the study
Method of measurement
Delirium Nelon Champagon Questionnaire and monitoring devise

Secondary outcomes

empty

Intervention groups

1

Description
In the control group, the visiting will be done in the usual way in the intensive care unit.In the test group, the visiting will be done accordance with the developed protocol. The protocol includes the appointment of a visitor, the training of him on how to meet and control the correct implementation of the visit.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Zahra Nazari Ostad
Street address
Nursing and Midwifery school, Daneshgah Street, Masshad, Iran
City
Masshad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3859 1511
Email
nazariz1@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Hajiabadi
Street address
Nursing and Midwifery School, Daneshgah Street, Mashhad
City
Masshad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3859 1511
Email
Hajiabadif@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Nazari Ostad
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Daneshgah Street, Masshad
City
Masshad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3859 1511
Fax
Email
nazariz1@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Hajiabadi
Position
Instructor of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery school, Daneshgah Street, Masshad
City
Masshad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3859 1511
Fax
Email
hajiabadif@MUMS.AC.IR
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Nazari Ostad
Position
Master of Seince Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery school, Daneshgah street, Masshad
City
Masshad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3859 1511
Fax
Email
nazariz1@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not 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
Only part of the information, such as information on the main outcome or the like, can be shared
When the data will become available and for how long
Start publishing results 6 months after the completion of the study
To whom data/document is available
Data will only be available to researchers in academia and academia
Under which criteria data/document could be used
Any analysis will be allowed
From where data/document is obtainable
To researcher email: Nazariz1@mums.ac.ir
What processes are involved for a request to access data/document
By email and within 2 weeks after receiving the request
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