The effect of lemon essence on anxiety, physiological indices and post-operative nausea & vomiting in patients undergoing lower limb fractures surgeries
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Protocol summary
Setting: Rajai, Chamran and Namazi hospitals, Data collector and statistician are blind.
Setting: Rajai, and Namazi hospitals, Data collector and statistician are blind.
Setting: Rajai, Chamran and Namazi hospitals, Data collector and statistician are blind.
محل: بیمارستان رجایی، چمران و نمازی و فرد جمع آوری کننده اطلاعات و متخصص آمار کورسازی می شوند.
محل: بیمارستان رجایی و نمازی و فرد جمع آوری کننده اطلاعات و متخصص آمار کورسازی می شوند.
محل: بیمارستان رجایی، چمران و نمازی و فرد جمع آوری کننده اطلاعات و متخصص آمار کورسازی می شوند.
Intervention group: Take five drops of lemon essence on a cotton pad and attached to the patient's collar with a pin at a distance of 20 cm from the head. Aromatherapy starts in the morning before the lower limb fracture surgery and will be extended at two-hour intervals until the end of the surgery, in recovery and 16 hours after surgery.
Control group: Bitter almond oil, which is odorless, will be used in a similar way of the intervention group.
Intervention group: Take five drops of lemon essence on a cotton pad and attached to the patient's collar with a pin at a distance of 20 cm from the head. Aromatherapy starts in the morning of the lower limb fracture surgery and will be extended at two-hour intervals until the end of the surgery, in recovery and 16 hours after surgery.
Control group: Bitter almond oil, which is odorless, will be used in a similar way of the intervention group.
Intervention group: Take five drops of lemon essence on a cotton pad and attached to the patient's collar with a pin at a distance of 20 cm from the head. Aromatherapy starts in the morning beforeof the lower limb fracture surgery and will be extended at two-hour intervals until the end of the surgery, in recovery and 16 hours after surgery. Control group: Bitter almond oil, which is odorless, will be used in a similar way of the intervention group.
گروه مداخله: پنج قطره اسانس لیمو را روی پنبه ای ریخته و به یقه بیمار با یک سوزن به فاصله 20 سانتی متر از سر وصل می شود. رایحه درمانی، صبح روز قبل از جراحی شکستگی اندام تحتانی شروع شده و هر دو ساعت تا پایان جراحی، در ریکاوری و 16 ساعت بعد از جراحی تمدید می شود.
گروه کنترل: روغن بادام تلخ که بدون بو است، به شیوه مشابه با گروه مداخله، برای این گروه استفاده می شود.
گروه مداخله: پنج قطره اسانس لیمو را روی پنبه ای ریخته و به یقه بیمار با یک سوزن به فاصله 20 سانتی متر از سر وصل می شود. رایحه درمانی، صبح روز جراحی شکستگی اندام تحتانی شروع شده و هر دو ساعت تا پایان جراحی، در ریکاوری و 16 ساعت بعد از جراحی تمدید می شود.
گروه کنترل: روغن بادام تلخ که بدون بو است، به شیوه مشابه با گروه مداخله، برای این گروه استفاده می شود.
گروه مداخله: پنج قطره اسانس لیمو را روی پنبه ای ریخته و به یقه بیمار با یک سوزن به فاصله 20 سانتی متر از سر وصل می شود. رایحه درمانی، صبح روز قبل از جراحی شکستگی اندام تحتانی شروع شده و هر دو ساعت تا پایان جراحی، در ریکاوری و 16 ساعت بعد از جراحی تمدید می شود. گروه کنترل: روغن بادام تلخ که بدون بو است، به شیوه مشابه با گروه مداخله، برای این گروه استفاده می شود.
General information
2021-07-29, 1400/05/07
2021-12-16, 1400/09/25
2021-0712-2916 00:00:00
2021-11-06, 1400/08/15
2022-03-06, 1400/12/15
20212022-1103-06 00:00:00
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Change in the time of start the intervention and setting of study
Change in the time of start the intervention and setting of study
empty
تغییر در زمان شروع مداخله و محل مطالعه
تغییر در زمان شروع مداخله و محل مطالعه
Firstly, Rajai, Chamran and Namazi hospitals are selected as three separate strata. Then, using Winpepi software and balanced randomization of separate strata, a list of random allocation is set for 90 patients. Therefore, according to the list in each stratum (hospital), 30 patients are randomly divided into the intervention or control groups.
Firstly, Rajai and Namazi hospitals are selected as two separate strata. Then, using Winpepi software and balanced randomization of separate strata, a list of random allocation is set for 90 patients. Therefore, according to the list in each stratum (hospital), 45 patients are randomly divided into the intervention or control groups.
Firstly, Rajai, Chamran and Namazi hospitals are selected as threetwo separate strata. Then, using Winpepi software and balanced randomization of separate strata, a list of random allocation is set for 90 patients. Therefore, according to the list in each stratum (hospital), 3045 patients are randomly divided into the intervention or control groups.
در ابتدا بیمارستان های رجایی، چمران و نمازی به عنوان سه طبقه مجزا انتخاب می شوند. سپس با استفاده از نرم افزارWinpepi و تصادفی سازی متعادل در طبقات مجزا، لیست تخصیص تصادفی برای 90 بیمار تنظیم می شود. بنابراین بر اساس لیست در هر طبقه (بیمارستان)، 30 بیمار به صورت تصادفی در گروه مداخله یا کنترل قرار می گیرند.
در ابتدا بیمارستان های رجایی و نمازی به عنوان دو طبقه مجزا انتخاب می شوند. سپس با استفاده از نرم افزارWinpepi و تصادفی سازی متعادل در طبقات مجزا، لیست تخصیص تصادفی برای 90 بیمار تنظیم می شود. بنابراین بر اساس لیست در هر طبقه (بیمارستان)، 45 بیمار به صورت تصادفی در گروه مداخله یا کنترل قرار می گیرند.
در ابتدا بیمارستان های رجایی، چمران و نمازی به عنوان سهدو طبقه مجزا انتخاب می شوند. سپس با استفاده از نرم افزارWinpepi و تصادفی سازی متعادل در طبقات مجزا، لیست تخصیص تصادفی برای 90 بیمار تنظیم می شود. بنابراین بر اساس لیست در هر طبقه (بیمارستان)، 3045 بیمار به صورت تصادفی در گروه مداخله یا کنترل قرار می گیرند.
Primary outcomes
#1
In the morning before surgery, the morning of the surgery and the day after surgery at 8 A.M.
In the morning of the surgery and the day after surgery at 8 A.M.
In the morning before surgery, the morning of the surgery and the day after surgery at 8 A.M.
صبح روز قبل از جراحی، صبح روز جراحی و روز بعد از جراحی در ساعت 8 صبح
صبح روز جراحی و روز بعد از جراحی در ساعت 8 صبح
صبح روز قبل از جراحی، صبح روز جراحی و روز بعد از جراحی در ساعت 8 صبح
#2
In the morning before the surgery, the morning of surgery, In the post-operative anesthesia care unit, after entering the orthopedic ward, and 4, 8, 12 and 16 hours after surgery
In the morning of surgery, In the post-operative anesthesia care unit, after entering the orthopedic ward, and 4, 8, 12 and 16 hours after surgery
In the morning before the surgery, the morning of surgery, In the post-operative anesthesia care unit, after entering the orthopedic ward, and 4, 8, 12 and 16 hours after surgery
صبح روز قبل از جراحی، صبح روز جراحی، در واحد مراقبت های بیهوشی بعد از عمل، بعد از ورود به بخش ارتوپدی و 4، 8، 12 و 16 ساعت بعد از عمل
صبح روز جراحی، در واحد مراقبت های بیهوشی بعد از عمل، بعد از ورود به بخش ارتوپدی و 4، 8، 12 و 16 ساعت بعد از عمل
صبح روز قبل از جراحی، صبح روز جراحی، در واحد مراقبت های بیهوشی بعد از عمل، بعد از ورود به بخش ارتوپدی و 4، 8، 12 و 16 ساعت بعد از عمل
#3
In the morning before the surgery, the morning of surgery, after entering the orthopedic ward, and 4, 8, 12 and 16 hours after surgery
In the morning of surgery, after entering the orthopedic ward, and 4, 8, 12 and 16 hours after surgery
In the morning before the surgery, the morning of surgery, after entering the orthopedic ward, and 4, 8, 12 and 16 hours after surgery
صبح روز قبل از جراحی، صبح روز جراحی، بعد از ورود به بخش ارتوپدی و 4، 8، 12 و 16 ساعت بعد از عمل
صبح روز جراحی، بعد از ورود به بخش ارتوپدی و 4، 8، 12 و 16 ساعت بعد از عمل
صبح روز قبل از جراحی، صبح روز جراحی، بعد از ورود به بخش ارتوپدی و 4، 8، 12 و 16 ساعت بعد از عمل
Intervention groups
#1
Intervention group: Take five drops of lemon essence on a cotton pad and attached to the patient's collar with a pin at a distance of 20 cm from the head. Aromatherapy starts in the morning before the lower limb fracture surgery and will be extended at two-hour intervals until the end of the surgery, in recovery room and 16 hours after surgery.
Intervention group: Take five drops of lemon essence on a cotton pad and attached to the patient's collar with a pin at a distance of 20 cm from the head. Aromatherapy starts in the morning of the lower limb fracture surgery and will be extended at two-hour intervals until the end of the surgery, in recovery room and 16 hours after surgery.
Intervention group: Take five drops of lemon essence on a cotton pad and attached to the patient's collar with a pin at a distance of 20 cm from the head. Aromatherapy starts in the morning beforeof the lower limb fracture surgery and will be extended at two-hour intervals until the end of the surgery, in recovery room and 16 hours after surgery.
گروه مداخله: پنج قطره اسانس لیمو را روی پنبه ای ریخته و به یقه بیمار با یک سوزن به فاصله 20 سانتی متر از سر وصل می شود. رایحه درمانی، صبح روز قبل از جراحی شکستگی اندام تحتانی شروع شده و هر دو ساعت تا پایان جراحی، در ریکاوری و 16 ساعت بعد از جراحی تمدید می شود.
گروه مداخله: پنج قطره اسانس لیمو را روی پنبه ای ریخته و به یقه بیمار با یک سوزن به فاصله 20 سانتی متر از سر وصل می شود. رایحه درمانی، صبح روز جراحی شکستگی اندام تحتانی شروع شده و هر دو ساعت تا پایان جراحی، در ریکاوری و 16 ساعت بعد از جراحی تمدید می شود.
گروه مداخله: پنج قطره اسانس لیمو را روی پنبه ای ریخته و به یقه بیمار با یک سوزن به فاصله 20 سانتی متر از سر وصل می شود. رایحه درمانی، صبح روز قبل از جراحی شکستگی اندام تحتانی شروع شده و هر دو ساعت تا پایان جراحی، در ریکاوری و 16 ساعت بعد از جراحی تمدید می شود.
Recruitment centers
#1
Name of recruitment center - English: Rajai, Chamran and Namazi hospitals
Name of recruitment center - Persian: بیمارستان های رجایی، چمران و نمازی
Full name of responsible person - English: Masoume Rambod
Full name of responsible person - Persian: معصومه رامبد
Street address - English: Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
Street address - Persian: شیراز، خیابان زند، میدان نمازی، دانشکده پرستاری مامایی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7193613119
Phone: +98 71 3647 4258
Fax:
Email: rambodma@yahoo.com
Web page address:
Name of recruitment center - English: Rajai hospitals
Name of recruitment center - Persian: بیمارستان رجایی
Full name of responsible person - English: Masoume Rambod
Full name of responsible person - Persian: معصومه رامبد
Street address - English: Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
Street address - Persian: شیراز، خیابان زند، میدان نمازی، دانشکده پرستاری مامایی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7193613119
Phone: +98 71 3647 4258
Fax:
Email: rambodma@yahoo.com
Web page address:
Name of recruitment center - English: Rajai, Chamran and Namazi hospitals Name of recruitment center - Persian: بیمارستان های رجایی، چمران و نمازی Full name of responsible person - English: Masoume Rambod Full name of responsible person - Persian: معصومه رامبد Street address - English: Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz Street address - Persian: شیراز، خیابان زند، میدان نمازی، دانشکده پرستاری مامایی City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7193613119 Phone: +98 71 3647 4258 Fax: Email: rambodma@yahoo.com Web page address:
#2
Name of recruitment center - English: Chamran hospital
Name of recruitment center - Persian: بیمارستان چمران
Full name of responsible person - English: Masoume Rambod
Full name of responsible person - Persian: معصومه رامبد
Street address - English: Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
Street address - Persian: شیراز، خیابان زند، میدان نمازی، دانشکده پرستاری مامایی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7193613119
Phone: +98 71 3647 4258
Fax:
Email: rambodma@yahoo.com
Web page address:
Name of recruitment center - English: Namazi hospital
Name of recruitment center - Persian: بیمارستان نمازی
Full name of responsible person - English: Masoume Rambod
Full name of responsible person - Persian: معصومه رامبد
Street address - English: Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
Street address - Persian: شیراز، خیابان زند، میدان نمازی، دانشکده پرستاری مامایی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7193613119
Phone: +98 71 3647 4258
Fax:
Email: rambodma@yahoo.com
Web page address:
Name of recruitment center - English: ChamranNamazi hospital Name of recruitment center - Persian: بیمارستان چمراننمازی Full name of responsible person - English: Masoume Rambod Full name of responsible person - Persian: معصومه رامبد Street address - English: Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz Street address - Persian: شیراز، خیابان زند، میدان نمازی، دانشکده پرستاری مامایی City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7193613119 Phone: +98 71 3647 4258 Fax: Email: rambodma@yahoo.com Web page address:
#3
Name of recruitment center - English: Namazi hospital
Name of recruitment center - Persian: بیمارستان نمازی
Full name of responsible person - English: Masoume Rambod
Full name of responsible person - Persian: معصومه رامبد
Street address - English: Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
Street address - Persian: شیراز، خیابان زند، میدان نمازی، دانشکده پرستاری مامایی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7193613119
Phone: +98 71 3647 4258
Fax:
Email: rambodma@yahoo.com
Web page address:
Name of recruitment center - English: Namazi hospital Name of recruitment center - Persian: بیمارستان نمازی Full name of responsible person - English: Masoume Rambod Full name of responsible person - Persian: معصومه رامبد Street address - English: Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz Street address - Persian: شیراز، خیابان زند، میدان نمازی، دانشکده پرستاری مامایی City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7193613119 Phone: +98 71 3647 4258 Fax: Email: rambodma@yahoo.com Web page address:
Protocol summary
Study aim
Determine the effect of lemon essence on anxiety, physiological indices and post-operative nausea & vomiting in patients undergoing lower limb fractures surgeries
Design
A clinical trial with control group, parallel group randomized trial, a single blinded
Settings and conduct
Setting: Rajai, and Namazi hospitals, Data collector and statistician are blind.
Participants/Inclusion and exclusion criteria
The inclusion criteria would be having lower limb fracture surgery, being hospitalized in Orthopedic surgery Wards for 24 hours before surgery, being 18 years old or above, and being oriented to time, person and place. The patient has an asthma, a respiratory allergy or be sensitive to extracts of the plant, has olfactory problems, and nasal injury, being known case of psychological diseases, participated in previous studies received complementary and alternative interventions from a week before the intervention, transfer to ICU after surgery, requires postoperative ventilator, and died would be excluded.
Intervention groups
Intervention group: Take five drops of lemon essence on a cotton pad and attached to the patient's collar with a pin at a distance of 20 cm from the head. Aromatherapy starts in the morning of the lower limb fracture surgery and will be extended at two-hour intervals until the end of the surgery, in recovery and 16 hours after surgery.
Control group: Bitter almond oil, which is odorless, will be used in a similar way of the intervention group.
Main outcome variables
Anxiety, physiological indices and post-operative nausea & vomiting
General information
Reason for update
Change in the time of start the intervention and setting of study
Acronym
IRCT registration information
IRCT registration number:IRCT20130616013690N10
Registration date:2021-07-24, 1400/05/02
Registration timing:prospective
Last update:2021-12-15, 1400/09/24
Update count:1
Registration date
2021-07-24, 1400/05/02
Registrant information
Name
Masoume Rambod
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4258
Email address
rambodm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-16, 1400/09/25
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lemon essence on anxiety, physiological indices and post-operative nausea & vomiting in patients undergoing lower limb fractures surgeries
Public title
The effect of lemon essence on patients undergoing lower limb fractures surgeries
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having Lower Limb Fracture Surgery
Hospitalization in orthopedic surgery Wards for 24 hours before surgery
Being 18 years old or above
Being oriented to time, person and place
Exclusion criteria:
Patient has an asthma, a respiratory allergy or be sensitive to extracts of the plant
The patient has olfactory problems, and nasal injury
Being known case of psychological diseases (major depression, anxiety, psychosis, etc.)
Participated in previous studies received complementary and alternative interventions from a week before the intervention
Transfer to ICU after surgery
Requires postoperative ventilator
Death of the patient
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Firstly, Rajai and Namazi hospitals are selected as two separate strata. Then, using Winpepi software and balanced randomization of separate strata, a list of random allocation is set for 90 patients. Therefore, according to the list in each stratum (hospital), 45 patients are randomly divided into the intervention or control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
To conducting blinding, assistant researcher who collects data, as well as statistician who analyzes the data, are blinded to the groups and the assignment of individuals in the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery, Management and Medical Information Sc
Street address
Vice chancellor for research affairs, seven floor, Shiraz University of Medical Science, beside Helal Ahmar, Zand Ave, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2021-06-08, 1400/03/18
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1400.001
Health conditions studied
1
Description of health condition studied
Lower limb fracture surgery
ICD-10 code
T84.11
ICD-10 code description
Breakdown (mechanical) of internal fixation device of bones of limb
Primary outcomes
1
Description
Anxiety
Timepoint
In the morning of the surgery and the day after surgery at 8 A.M.
Method of measurement
State-Trait Anxiety Inventory
2
Description
Physiological indices (blood pressure, SPO2, respiration, temperature and pain)
Timepoint
In the morning of surgery, In the post-operative anesthesia care unit, after entering the orthopedic ward, and 4, 8, 12 and 16 hours after surgery
Method of measurement
Digital blood pressure monitors, Pulse Oximeter, Chronometer, MASTECH Non Contact Infrared Medical Thermometer and numeric analogue pain
3
Description
Neurovascular assessment of lower limb
Timepoint
In the morning of surgery, after entering the orthopedic ward, and 4, 8, 12 and 16 hours after surgery
Method of measurement
WACHS Neurovascular Observation Charts
4
Description
Post-operative nausea and vomiting
Timepoint
In the post-operative anesthesia care unit, 4, 8, 12 and 16 hours after surgery
Method of measurement
Rhodes Index of Nausea, Vomiting and Retching and Numeric Analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Take five drops of lemon essence on a cotton pad and attached to the patient's collar with a pin at a distance of 20 cm from the head. Aromatherapy starts in the morning of the lower limb fracture surgery and will be extended at two-hour intervals until the end of the surgery, in recovery room and 16 hours after surgery.
Category
Prevention
2
Description
Control group: Bitter almond oil, which is odorless, will be used in a similar way of the intervention group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajai hospitals
Full name of responsible person
Masoume Rambod
Street address
Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4258
Email
rambodma@yahoo.com
2
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Masoume Rambod
Street address
Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4258
Email
rambodma@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaieanzadeh
Street address
Vice chancellor for research affairs of Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
23210
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Masoume Rambod
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Shiraz. Zand Street, Namazi Square. School of Nursing Midwifery, Shiraz
City
Shiraz
Province
Fars
Postal code
71936–13119
Phone
+98 71 3677 4254
Email
rambodma@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoume Rambod
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4258
Email
rambodma@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoume Rambod
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4258
Email
rambodma@yahoo.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
Primary outcomes would be shared.
When the data will become available and for how long
Starting 6 months after publication article
To whom data/document is available
People and researchers working in academic institutions
Under which criteria data/document could be used
Data are provided for information only.
From where data/document is obtainable
Data is available via email rambodma@yahoo.com.
What processes are involved for a request to access data/document