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The effect of percutaneous electrical nerve stimulation on the respiratory outcomes of patients with Covid-19 with moderate pulmonary involvement: A clinical trial

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History
# Registration date Revision Id
2 2022-06-13, 1401/03/23 232521
1 2021-04-25, 1400/02/05 180075
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  • Protocol summary

    A clinical trial with a control group, with parallel groups, three-way, randomized, on 120 patients. For randomization, the 4-block method was used using software.
    A clinical trial with a control group, with parallel groups, three-way, randomized, on 84 patients. For randomization, the 4-block method was used using software.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، سه سویه کور ، تصادفی شده، بر روی 120 بیمار. برای تصادفی سازی از روش بلوک 4 تایی با استفاده از نرم افزار کمک گرفته شد.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، سه سویه کور ، تصادفی شده، بر روی 84 بیمار. برای تصادفی سازی از روش بلوک 4 تایی با استفاده از نرم افزار کمک گرفته شد.
    Participants in the study are selected from all patients in the wards of Imam Hossein Hospital in Shahroud. After random allocation of patients with two intervention and control groups, the intervention is performed in such a way that two plastic electrodes of 5 × 5 cm and adhesive are placed on both sides of the spinal appendage of the 7-neck vertebra; The electrodes are connected to the device and will be set for 45 minutes. In the case of the control group, the electrodes of the device are connected to the non-respiratory acupuncture points (anterior of the chest) and the current is established in the same way. Participants, data collectors and statistical analysts were also blinded to the groups.
    Participants in the study are selected from all patients in the wards of Imam Hossein Hospital in Shahroud. After random assignment of patients with two intervention and control groups, the intervention is performed in such a way that two electrodes are placed on both sides of the spinal cord of the 7-neck vertebra, and in the control group, the electrodes are placed on non-acupuncture points. Breathing (anterior to the chest) is connected and flow is established. Participants, data collectors and statistical analysts were also blinded to the groups.
    شركت كنندگان در مطالعه از بین تمام بیماران بخش های بیمارستان امام حسین (ع) شهرستان شاهرود انتخاب می شوند. پس از تخصیص تصادفی بیماران با دو گروه مداخله و کنترل، مداخله به این صورت اجرا می شود که دو الکترود در دو طرف زائده خاری مهره 7 گردنی قرار داده می شود و در مورد گروه کنترل نیز الکترودهای دستگاه بر روی نقاط طب سوزنی غیر مربوط به تنفس (قدام قفسه سینه) متصل شده و جریان برقرار می شود. شرکت کنندگان، جمع آوری کننده داده ها و تحلیل گر آماری نیز نسبت به گروه ها کورسازی شده اند.
    شركت كنندگان در مطالعه از بین تمام بیماران بخش های بیمارستان امام حسین (ع) شهرستان شاهرود انتخاب می شوند. پس از تخصیص تصادفی بیماران با دو گروه مداخله و کنترل، مداخله به این صورت اجرا می شود که دو الکترود در دو طرف زائده خاری مهره 7 گردنی قرار داده می شود و در مورد گروه کنترل نیز الکترودهای دستگاه بر روی نقاط طب سوزنی غیر مربوط به تنفس (قدام قفسه سینه) متصل شده و جریان برقرار می شود. شرکت کنندگان، جمع آوری کننده داده ها و تحلیل گر آماری نیز نسبت به گروه ها کورسازی شده اند.
    Participants in the study are selected from all patients in the wards of Imam Hossein Hospital in Shahroud. After random assignment of patients with two intervention and control groups, the intervention is performed in such a way that two electrodes are placed on both sides of the 7-neck vertebral appendage and in the control group, the electrodes of the device on acupuncture points not related to breathing (anterior to the chest) is connected and flow is established.
    In the intervention group, the patient is placed in a sitting or semi-sitting position, two plastic electrodes of 5 * 5 cm and adhesive are placed on both sides of the spinal appendage of the 7-neck vertebra; The electrodes are connected to NOVIN701P PLUS-STIMULATOR device made in Iran and serial number AX212088 and the frequency is set to 4 Hz and the pulse is set to 200 MICROSEC with a duration of 45 minutes. In the control group, the electrodes of the device are connected to the non-respiratory acupuncture points (anterior of the chest) and the current is established in the same way.
    در گروه مداخله بیمار در وضعیت نشسته یا نیمه نشسته قرار می گیرد و با کنترل پوست ناحیه از نظر ضایعه، دو الکترود پلاستیکی 5×5 سانتی متر و چسبنده در دو طرف زائده خاری مهره 7 گردنی قرار داده می شود؛ الکترود ها به دستگاه NOVIN701P PLUS-STIMULATOR کشور سازنده ایران و شماره سریال AX212088 متصل شده و فرکوئنسی روی 4 هرتز تنطیم و پالس 200 MICROSEC با مدت زمان 45 دقیقه تنظیم خواهد شد. در مورد گروه کنترل نیز الکترودهای دستگاه بر روی نقاط طب سوزنی غیر مربوط به تنفس (قدام قفسه سینه) متصل شده و جریان به همان صورت برقرار می شود.
    در گروه مداخله بیمار در وضعیت نشسته یا نیمه نشسته قرار می گیرد، دو الکترود پلاستیکی 5×5 سانتی متر و چسبنده در دو طرف زائده خاری مهره 7 گردنی قرار داده می شود؛ الکترود ها به دستگاه NOVIN701P PLUS-STIMULATOR کشور سازنده ایران و شماره سریال AX212088 متصل شده و فرکوئنسی روی 4 هرتز تنطیم و پالس 200 MICROSEC با مدت زمان 45دقیقه تنظیم خواهد شد. در مورد گروه کنترل نیز الکترودهای دستگاه بر روی نقاط طب سوزنی غیر مربوط به تنفس (قدام قفسه سینه) متصل شده و جریان به همان صورت برقرار می شود.

  • General information

    120
    84
    empty
    82
    empty
    2021-06-01, 1400/03/11
    empty
    2021-09-30, 1400/07/08
    empty
    Change in sample size and update the realized sampling time The order of study outcomes also changed according to the importance of the outcomes observed during the implementation of the intervention and updated treatment protocols. In addition, the quality of shortness of breath was eliminated due to overlap with other outcomes and the large number of questions asked of the patient, leading to fatigue.
    empty
    تغییر در حجم نمونه و به روز رسانی زمان تحقق یافته نمونه گیری ترتیب پیامدهای مطالعه نیز با توجه به اهمیت پیامدهایی که در زمان اجرای مداخله و پروتکل های درمانی به روز مشاهده شد، تغییر یافت. به علاوه کیفیت تنگی نفس نیز به دلیل همپوشانی با سایر پیامدها و تعداد زیاد سوالاتی که از بیمار پرسیده می شد و خستگی را در پی داشت حذف شد
    The 4-block block randomization method is used to create a random allocation sequence in this study because the participants gradually enter the study and also the number of assignments to each group is equal. In this research, the random allocation sequence is obtained by the methodology consultant with the software. After creating a random sequence, 112 opaque envelopes with wrappers are prepared and each random sequence is recorded on a card and placed inside the envelopes and closed. In order to maintain the sequence and to prevent disruption, the envelopes will be numbered and placed in a box. Eligible participants will be registered by the principal investigator in the order of their arrival, and an envelope will be opened in the order in which the person enters the study, one of the envelopes will be opened, and thus his / her assigned group will be revealed. Individuals will be placed equally in each group.
    The 4-block block randomization method is used to create a random allocation sequence in this study because the participants gradually enter the study and also the number of assignments to each group is equal. In this research, the random allocation sequence is obtained by the methodology consultant with the software. After creating a random sequence, 84 opaque envelopes with wrappers are prepared and each random sequence is recorded on a card and placed inside the envelopes and closed. In order to maintain the sequence and to prevent disruption, the envelopes will be numbered and placed in a box. Eligible participants will be registered by the principal investigator in the order of their arrival, and an envelope will be opened in the order in which the person enters the study, one of the envelopes will be opened, and thus his / her assigned group will be revealed. Individuals will be placed equally in each group.
    از روش تصادفی سازی بلوکی به حجم 4 برای ایجاد توالی تخصیص تصادفی در این پژوهش استفاده می شود به این دلیل که افراد شرکت کننده به تدریج وارد مطالعه می شوند و همچنین تعداد تخصیص یافتگان به هر گروه با هم برابر باشد. در این پژوهش توالی تخصیص تصادفی توسط مشاور روش شناسی با نرم افزار به دست می آید. بعد از ایجاد توالی تصادفی، تعداد 112 پاکت نامه غیرشفاف دارای لفاف تهیه و هر یک از توالی های تصادفی روی یک کارت ثبت شده و داخل پاکت ها قرار داده و بسته خواهد شد. به منظور حفظ توالی و برای جلوگیری از به هم خوردن ترتیب پاکت ها روی آن ها نیز شماره گذاری شده و داخل یک جعبه قرار خواهد گرفت. شرکت کنندگان واجد شرایط، به ترتیب ورودشان توسط پژوهشگر اصلی ثبت نام می شوند و براساس ترتیب ورود فرد به مطالعه یک پاکت باز می شود، یکی از پاکت های نامه باز خواهد شد و به این ترتیب گروه تخصیص یافته او آشکار گردیده و به این صورت افراد به شکل مساوی در هر یک از گروه ها قرار خواهند گرفتند.
    از روش تصادفی سازی بلوکی به حجم 4 برای ایجاد توالی تخصیص تصادفی در این پژوهش استفاده می شود به این دلیل که افراد شرکت کننده به تدریج وارد مطالعه می شوند و همچنین تعداد تخصیص یافتگان به هر گروه با هم برابر باشد. در این پژوهش توالی تخصیص تصادفی توسط مشاور روش شناسی با نرم افزار به دست می آید. بعد از ایجاد توالی تصادفی، تعداد 84 پاکت نامه غیرشفاف دارای لفاف تهیه و هر یک از توالی های تصادفی روی یک کارت ثبت شده و داخل پاکت ها قرار داده و بسته خواهد شد. به منظور حفظ توالی و برای جلوگیری از به هم خوردن ترتیب پاکت ها روی آن ها نیز شماره گذاری شده و داخل یک جعبه قرار خواهد گرفت. شرکت کنندگان واجد شرایط، به ترتیب ورودشان توسط پژوهشگر اصلی ثبت نام می شوند و براساس ترتیب ورود فرد به مطالعه یک پاکت باز می شود، یکی از پاکت های نامه باز خواهد شد و به این ترتیب گروه تخصیص یافته او آشکار گردیده و به این صورت افراد به شکل مساوی در هر یک از گروه ها قرار خواهند گرفتند.

  • Primary outcomes

    #1
    Dyspnea Severity
    Percentage of arterial blood oxygen saturation
    شدت دیسپنه
    درصد اشباع اکسیژن خون شریانی
    Daily for up to 4 days
    Daily for up to 4 days before and after the intervention
    روزانه تا 4 روز
    روزانه تا 4 روز قبل و بعد از مداخله
    Dyspnea Severity Visual Analogue Scale
    Finger pulse oximeter device and monitor
    مقیاس عددی دیداری شدت تنگی نفس
    دستگاه و مانیتور پالس اکسی متری انگشتی
    #2
    Dyspnea Quality
    need for mechanical ventilation
    کیفیت دیسپنه
    نیاز به تهویه مکانیکی
    Daily for up to 4 days
    4, 8 and 12 days after the intervention
    روزانه تا 4 روز
    4، 8 و 12 روز بعد از مداخله
    Modified Medical Research Council (mMRC) Dyspnea Scale
    Checklist
    ابزار تنگی نفس تعدیل یافته پژوهشکده پزشکی
    چک لیست
    #3
    Quality of dyspnea and respiratory effort
    Death and survival
    کیفیت دیسپنه و تلاش تنفسی
    مرگ و بقا
    Daily for up to 4 days
    until the end of hospitalization
    روزانه تا 4 روز
    تا پایان روزهای بستری
    6-item questionnaire with the need to answer yes / no related to the respiratory effort of patients with Covid-19
    Checklist
    پرسشنامه 6 آیتمی با نیاز به پاسخ بله / خیر مربوط به تلاش تنفسی بیماران مبتلا به کووید-19
    چک لیست
    #4
    Requires mechanical ventilation
    vital signs (RR,HR)
    نیاز به تهویه مکانیکی
    علائم حیاتی (تنفس و ضربان قلب)
    From the first day until the patient is hospitalized
    Daily for up to 4 days before and after the intervention
    از روز اول تا زمان بستری بیمار در بیمارستان
    روزانه تا 4 روز قبل و بعد از مداخله
    Mechanical Ventilation Data Collection Checklist
    Count the respiratory rate and heart rate in a minute and record them in a checklist
    چک لیست جمع آوری داده های مربوط به تهویه مکانیکی
    شمارش تعداد تنفس و ضربان قلب در یک دقیقه کامل و ثبت در چک لیست
    #5
    Patient respiration rate
    Severity of breathing (Dyspnea)
    تعداد تنفس بیمار
    شدت تنگی نفس
    Daily for up to 4 days
    Daily for up to 4 days before and after the intervention
    روزانه تا 4 روز
    روزانه تا 4 روز قبل و بعد از مداخله
    Count by the researcher in one full minute
    Visual Analogue scale for dyspnea (VASD)
    شمارش توسط پژوهشگر در یک دقیقه کامل
    ابزار شدت تنگی نفس دیداری
    #6
    Patient pulse rate
    empty
    تعداد نبض بیمار
    empty
    Daily for up to 4 days
    empty
    روزانه تا 4 روز
    empty
    Count by the researcher in one full minute
    empty
    شمارش توسط پژوهشگر در یک دقیقه کامل
    empty
    #7
    Percentage of arterial blood oxygen saturation
    empty
    درصد اشباع اکسیژن خون شریانی
    empty
    Daily for up to 4 days
    empty
    روزانه تا 4 روز
    empty
    Finger pulse oximeter device and monitor
    empty
    دستگاه و مانیتور پالس اکسی متری انگشتی
    empty

  • Intervention groups

    #1
    Control group: performed by a researcher who does not know the assignment of groups under the supervision of a trained Acu-TENS physiotherapist ineffective for the control group in such a way that the patient is placed in a sitting or semi-sitting position and by re-controlling the skin of in view of the lesion, two plastic electrodes of 5 و 5 cm and adhesive are placed in an ineffective point for breathing, the front of the chest; The electrodes are connected to NOVIN701P PLUS-STIMULATOR device made in Iran and serial number AX212088 and the frequency is set to 4 Hz and the pulse is set to 200 MICROSEC with a duration of 45 minutes.
    Control group: by a researcher who does not know the assignment of groups under the supervision of a trained physiotherapist, ineffective Acu-TENS was performed for the control group in such a way that the patient is placed in a sitting or semi-sitting position and by re-controlling, the skin of in view of the lesion, two plastic electrodes of 5* 5 cm and adhesive are placed in an ineffective point for breathing, the front of the chest; The electrodes are connected to NOVIN701P PLUS-STIMULATOR device made in Iran and serial number AX212088 and the frequency is set to 4 Hz and the pulse is set to 200 MICROSEC with a duration of 45 minutes.

Protocol summary

Study aim
Determining the effect of percutaneous electrical nerve stimulation on respiratory outcomes in patients with Covid-19
Design
A clinical trial with a control group, with parallel groups, three-way, randomized, on 84 patients. For randomization, the 4-block method was used using software.
Settings and conduct
Participants in the study are selected from all patients in the wards of Imam Hossein Hospital in Shahroud. After random assignment of patients with two intervention and control groups, the intervention is performed in such a way that two electrodes are placed on both sides of the spinal cord of the 7-neck vertebra, and in the control group, the electrodes are placed on non-acupuncture points. Breathing (anterior to the chest) is connected and flow is established. Participants, data collectors and statistical analysts were also blinded to the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Covid-19 with moderate pulmonary involvement Non-entry or exclusion criteria: Addiction, heart disease, liver, respiratory, kidney and advanced cancer, history of allergies and skin lesions and obesity and prohibition to be in a semi-sitting position
Intervention groups
In the intervention group, the patient is placed in a sitting or semi-sitting position, two plastic electrodes of 5 * 5 cm and adhesive are placed on both sides of the spinal appendage of the 7-neck vertebra; The electrodes are connected to NOVIN701P PLUS-STIMULATOR device made in Iran and serial number AX212088 and the frequency is set to 4 Hz and the pulse is set to 200 MICROSEC with a duration of 45 minutes. In the control group, the electrodes of the device are connected to the non-respiratory acupuncture points (anterior of the chest) and the current is established in the same way.
Main outcome variables
Respiratory consequences

General information

Reason for update
Change in sample size and update the realized sampling time The order of study outcomes also changed according to the importance of the outcomes observed during the implementation of the intervention and updated treatment protocols. In addition, the quality of shortness of breath was eliminated due to overlap with other outcomes and the large number of questions asked of the patient, leading to fatigue.
Acronym
IRCT registration information
IRCT registration number: IRCT20210406050871N1
Registration date: 2021-04-25, 1400/02/05
Registration timing: prospective

Last update: 2022-07-06, 1401/04/15
Update count: 1
Registration date
2021-04-25, 1400/02/05
Registrant information
Name
Amin Shahdad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3234 2901
Email address
amin.shahdad2019@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-30, 1400/02/10
Expected recruitment end date
2021-08-01, 1400/05/10
Actual recruitment start date
2021-06-01, 1400/03/11
Actual recruitment end date
2021-09-30, 1400/07/08
Trial completion date
empty
Scientific title
The effect of percutaneous electrical nerve stimulation on the respiratory outcomes of patients with Covid-19 with moderate pulmonary involvement: A clinical trial
Public title
The effect of percutaneous electrical nerve stimulation on the respiratory outcomes of patients with Covid-19 with moderate pulmonary involvement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of Covid-19 diagnosis based on PCR test results or CT Scan findings (Ground Glass view) by physician Age over 18 and under 70 years Use the same treatment protocol for patients Existence of moderate pulmonary involvement (SpO2 between 90 to 93% and pulmonary involvement less than 50%) and the patient being in the second phase of Covid-19 disease according to the guideline of the Ministry of Health
Exclusion criteria:
Drug addiction Cigarette addiction Advanced metastatic cancer Congestive heart failure (grades 3 and 4) Kidney failure requires dialysis History of mechanical ventilation before intervention Existence of cardiac pacemaker Cardiac conduction disorders History of allergies and skin sensitivities in the area of ​​the electrodes The presence of a skin lesion in the area where the electrodes are placed Hospitalized patients with other clinical manifestations of Covid-19 and no pulmonary involvement Continuous use of bronchodilators Having liver failure Moderate to severe scoliosis Obesity (BMI above 35) Psychological illnesses lead to lack of patient cooperation Cerebrovascular disorders Having COPD Having uncontrolled diabetes Inability and prohibition to be in a semi-sitting position for any reason
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 84
Actual sample size reached: 82
Randomization (investigator's opinion)
Randomized
Randomization description
The 4-block block randomization method is used to create a random allocation sequence in this study because the participants gradually enter the study and also the number of assignments to each group is equal. In this research, the random allocation sequence is obtained by the methodology consultant with the software. After creating a random sequence, 84 opaque envelopes with wrappers are prepared and each random sequence is recorded on a card and placed inside the envelopes and closed. In order to maintain the sequence and to prevent disruption, the envelopes will be numbered and placed in a box. Eligible participants will be registered by the principal investigator in the order of their arrival, and an envelope will be opened in the order in which the person enters the study, one of the envelopes will be opened, and thus his / her assigned group will be revealed. Individuals will be placed equally in each group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The present study is three-blind and in addition to the participants, the data collector (outcome assessor) and the statistical analyst are not aware of the allocation of groups. The data collector who is involved in collecting and recording information such as respiration rate, pulse, oxygen saturation, etc., or in completing questionnaires will be unaware of the group of individuals. The analyst will also be unaware of the group of people. It should be noted that the physiotherapist who is responsible for the intervention and is known as the caregiver, by contacting the research colleague who has the sequence, becomes aware of the group to which each person is assigned and performs the intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
7th Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3616718473
Approval date
2021-04-11, 1400/01/22
Ethics committee reference number
IR.SHMU.REC.1400.008

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Coronavirus disease (COVID-19)

Primary outcomes

1

Description
Percentage of arterial blood oxygen saturation
Timepoint
Daily for up to 4 days before and after the intervention
Method of measurement
Finger pulse oximeter device and monitor

2

Description
need for mechanical ventilation
Timepoint
4, 8 and 12 days after the intervention
Method of measurement
Checklist

3

Description
Death and survival
Timepoint
until the end of hospitalization
Method of measurement
Checklist

4

Description
vital signs (RR,HR)
Timepoint
Daily for up to 4 days before and after the intervention
Method of measurement
Count the respiratory rate and heart rate in a minute and record them in a checklist

5

Description
Severity of breathing (Dyspnea)
Timepoint
Daily for up to 4 days before and after the intervention
Method of measurement
Visual Analogue scale for dyspnea (VASD)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: is performed by a researcher who does not know the assignment of groups under the supervision of an Acu-TENS trained physiotherapist for the intervention group in such a way that the patient is in a sitting or semi-sitting position and by re-controlling the skin of the area for lesions, Two plastic electrodes 5 × 5 cm and sticky are placed on both sides of the spine appendage of 7 cervical vertebrae; The electrodes are connected to NOVIN701P PLUS-STIMULATOR device made in Iran and serial number AX212088 and the frequency is set to 4 Hz and the pulse is set to 200 MICROSEC with a duration of 45 minutes.
Category
Treatment - Devices

2

Description
Control group: by a researcher who does not know the assignment of groups under the supervision of a trained physiotherapist, ineffective Acu-TENS was performed for the control group in such a way that the patient is placed in a sitting or semi-sitting position and by re-controlling, the skin of in view of the lesion, two plastic electrodes of 5* 5 cm and adhesive are placed in an ineffective point for breathing, the front of the chest; The electrodes are connected to NOVIN701P PLUS-STIMULATOR device made in Iran and serial number AX212088 and the frequency is set to 4 Hz and the pulse is set to 200 MICROSEC with a duration of 45 minutes.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Mahboobeh Khajeh
Street address
7 thTir Square., Shahroud University of Medical Sciences
City
شاهرود
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5054
Email
m_khajeh@ymail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamiyan
Street address
Haft Tir Square., Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5054
Email
pishgiri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Mahboobeh Khajeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
7th Tir Square. Shahroud University of Medical Sciences
City
شاهرود
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5054
Email
m_khajeh@ymail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mahboobeh Khajeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
7th Tir Square. Shahroud University of Medical Sciences
City
شاهرود
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5054
Email
m_khajeh@ymail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Amin Shahdad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Azadi.
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3234 2901
Fax
Email
Amin.shahdad2019@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
If necessary, contact Dr. Mahboobeh Khajeh and if there is a reasonable justification for use in scientific purposes
From where data/document is obtainable
Dr. Mahboobeh Khajeh Shahroud, 7thTir Square, Shahroud University of Medical Sciences; School of Nursing and Midwifery 02332395054 m_khajeh@ymail.com
What processes are involved for a request to access data/document
By phone call or by email and registration of the request and stating the reason and purpose of the logical and approved up to two weeks
Comments
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