Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Main inclusion criteria: Patients having a cell phone
Main exclusion criteria: Patients who do not agree to continue their cooperation
This randomized controlled trial (RCT) study is a 12-weeks, two-arm, parallel RCT to evaluate the effectiveness of a text message-based intervention, on primary and secondary outcomes of patients with flexor tendon injury after repair. Forty patients will be randomized in a 1:1 ratio to either the intervention group or the control group using an online random number generator and the sequence will be concealed in sequentially numbered sealed envelopes.
Main inclusion criteria: Patients havingThis randomized controlled trial (RCT) study is a cell phone Main exclusion criteria: Patients who do not agree12-weeks, two-arm, parallel RCT to continue their cooperationevaluate the effectiveness of a text message-based intervention, on primary and secondary outcomes of patients with flexor tendon injury after repair. Forty patients will be randomized in a 1:1 ratio to either the intervention group or the control group using an online random number generator and the sequence will be concealed in sequentially numbered sealed envelopes.
در این مطالعه 36 بیمار دچار آسیب تاندون فلکسور دست و دارای شرایط ورود به مطالعه که به بیمارستان امام رضا مشهد مراجعه می کنند به صورت تصادفی به دو گروه مداخله و کنترل تقسیم می شوند.
این مطالعه یک کارازمایی بالینی تصادفی سازی شده 12 هفته و دوبازویه بصورت موازی جهت ارزیابی تاثیر مداخله مبتنی بر پیام کوتاه بر پیامدهای اولیه و ثانویه بیماران دچار آسیب تاندون دست پس از ترمیم می باشد. 40 بیمار به نسبت 1 به 1 به دو گروه کنترل و مداخله با استفاده از سایت آنلاین ایجاد کننده توالی تصادفی، تصادفی سازی می شوند و توالی در پاکت های شماره گذاری شده مهر و موم شده قرار داده می شوند.
در این مطالعه 36 بیماریک کارازمایی بالینی تصادفی سازی شده 12 هفته و دوبازویه بصورت موازی جهت ارزیابی تاثیر مداخله مبتنی بر پیام کوتاه بر پیامدهای اولیه و ثانویه بیماران دچار آسیب تاندون فلکسور دست و دارای شرایط ورودپس از ترمیم می باشد. 40 بیمار به مطالعه کهنسبت 1 به بیمارستان امام رضا مشهد مراجعه می کنند به صورت تصادفی1 به دو گروه مداخلهکنترل و کنترل تقسیممداخله با استفاده از سایت آنلاین ایجاد کننده توالی تصادفی، تصادفی سازی می شوند و توالی در پاکت های شماره گذاری شده مهر و موم شده قرار داده می شوند.
setting: Imam Reza Hospital in Mashhad
The study is randomized, one blind, parallel and in a single center
setting: Imam Reza Hospital in Mashhad
The study is randomized, one blinded, parallel and in a single center
setting: Imam Reza Hospital in Mashhad The study is randomized, one blindblinded, parallel and in a single center
محل انجام مطالعه: بیمارستان امام رضا مشهد
مطالعه به صورت تصادفي،بدون کورسازی، موازی و تک مركزي می باشد
محل انجام مطالعه: بیمارستان امام رضا مشهد
مطالعه به صورت تصادفي،یکسویه کور، موازی و تک مركزي می باشد
محل انجام مطالعه: بیمارستان امام رضا مشهد مطالعه به صورت تصادفي،بدون کورسازییکسویه کور، موازی و تک مركزي می باشد
Participants: Patients with flexor tendon injuries
Main inclusion criteria: Patients with flexor tendon injuries after repair
Exclusion criteria: Patients who have tendon injury with fracture
ParticipantsMain inclusion criteria: Patients with flexor tendon injuries after repair Exclusion criteria: Patients who have tendon injury with fracture
شرکت کنندگان: بیماران دچار آسیب تاندون فلکسور دست
شرط ورود اصلی: بیماران دچار آسیب تاندون فلکسور دست پس از ترمیم
شرط خروج: بیمارانی که دچار آسیب تاندون دست با شکستگی همراه هستند.
شرکت کنندگانشرط ورود اصلی: بیماران دچار آسیب تاندون فلکسور دست پس از ترمیم شرط خروج: بیمارانی که دچار آسیب تاندون دست با شکستگی همراه هستند.
Intervention: SMS and educational video link
Patients who are underwent flexor tendon repair in the intervention groups will receive text messages about postoperative care for 12 weeks at no cost the day after the patient is discharged from the hospital in addition to usual care.
Patients in the control group will receive only usual care.
Intervention: SMS and educational video linkPatients who are underwent flexor tendon repair in the intervention groups will receive text messages about postoperative care for 12 weeks at no cost the day after the patient is discharged from the hospital in addition to usual care. Patients in the control group will receive only usual care.
مداخله: پیام کوتاه و تارنمای فیلم آموزشی
بیمارانی که تحت عمل ترمیمی تاندون دست قرار گرفته اند و در گروه مداخله می باشند پیام های کوتاهی در رابطه با مراقبت بعد از عمل به مدت 12 هفته بدون هیچ هزینه ای یک روز پس از ترخیص از بیمارستان به علاوه مراقبت معمول دریافت می کنند.
بیماران گروه کنترل تنها مراقبت معمول را دریافت می کنند.
بیمارانی که تحت عمل ترمیمی تاندون دست قرار گرفته اند و در گروه مداخله: می باشند پیام کوتاه و تارنمای فیلم آموزشیهای کوتاهی در رابطه با مراقبت بعد از عمل به مدت 12 هفته بدون هیچ هزینه ای یک روز پس از ترخیص از بیمارستان به علاوه مراقبت معمول دریافت می کنند. بیماران گروه کنترل تنها مراقبت معمول را دریافت می کنند.
Main outcome: Dash score
Patient Rated Wrist Evaluation score
Main outcome: DashPatient Rated Wrist Evaluation score
پيامد اصلی: اسکور دش
امتیاز ارزیابی مچ دست بیمار
پيامد اصلی: اسکور دشامتیاز ارزیابی مچ دست بیمار
General information
empty
65
65
empty
Year
year
Yes
No
1
1
1
1
1
1
1
36
40
3640
2017-12-22, 1396/10/01
2018-08-23, 1397/06/01
20172018-1208-2223 00:00:00
2018-12-22, 1397/10/01
2019-09-21, 1398/06/30
20182019-1209-2221 00:00:00
Main inclusion criteria: Patients who have a cell phone
patients who have flexor tendon injury with no fracture
patients who are underwent flexor tendon repair
Patients who have a cell phone
Main inclusion criteria:patients who have flexor tendon injury with no fracture patients who are underwent flexor tendon repair Patients who have a cell phone
معيار اصلی ورود به مطالعه: بیمارانی که دارای تلفن همراه باشند
بیمارانی که دچار پارگی تاندون فلکسور دست بدون شکستگی همراه شده باشند
بیمارانی که تحت عمل عمل ترمیم تاندون فلکسور قرار گرفته اند
بیمارانی که دارای تلفن همراه باشند
معيار اصلی ورود به مطالعه:بیمارانی که دچار پارگی تاندون فلکسور دست بدون شکستگی همراه شده باشند بیمارانی که تحت عمل عمل ترمیم تاندون فلکسور قرار گرفته اند بیمارانی که دارای تلفن همراه باشند
Main exclusion criteria: Patients who do not agree to continue their cooperation
Patients who do not agree to continue their cooperation
Main exclusion criteria: Patients who do not agree to continue their cooperation
معيار اصلی خروج از مطالعه: بیمارانی که با ادامه همکاری خود موافق نیستند
بیمارانی که با ادامه همکاری خود موافق نیستند
معيار اصلی خروج از مطالعه: بیمارانی که با ادامه همکاری خود موافق نیستند
simple randomization
individual randomization
The tool we use in randomization: sealed envelops
We use www.randomization.com website for random sequence
Method of randomization is simple individual randomization. We use a website for the random sequence using an online random number generator. A member of the research team will conceal the assignment of subjects to each group in sequentially numbered opaque, sealed envelopes.
simpleMethod of randomization is simple individual randomization The tool we use in randomization: sealed envelops. We use www.randomization.coma website for the random sequence using an online random number generator. A member of the research team will conceal the assignment of subjects to each group in sequentially numbered opaque, sealed envelopes.
تصادفی سازی ساده
تصادفی سازی فردی
ابزار تصادفی سازی: پاکت مهرو موم شده
نحوه ساخت توالی تصادفی: استفاده از سایت www.Randomization.com
روش تصادفی سازی، ساده و بصورت فردی می باشد. ما از یک سایت تولید توالی تصادفی استفاده می کنیم. یک عضو از تیم پژوهش تخصیص افراد به هر گروه را در پاکت های شماره گذاری شده مهرو موم شده نامرئی پنهان می کند.
تصادفی سازی سادهروش تصادفی سازی، ساده و بصورت فردی ابزارمی باشد. ما از یک سایت تولید توالی تصادفی سازی:استفاده می کنیم. یک عضو از تیم پژوهش تخصیص افراد به هر گروه را در پاکت های شماره گذاری شده مهرو موم شده نحوه ساخت توالی تصادفی: استفاده از سایت www.Randomization.comنامرئی پنهان می کند.
Outcome assessor will be blinded in our study and he will not know the group of patients that their outcomes are evaluating
Outcome assessor and care providers will be blinded in our study and they will not know the group of patients that their outcomes will be evaluated.
Outcome assessor and care providers will be blinded in our study and hethey will not know the group of patients that their outcomes are evaluatingwill be evaluated.
ارزیاب پیامد در مطالعه ما کورسازی خواهد شد و گروه بیمارانی که ارزیابی نتایج درمان آنها را انجام می دهد، نمی داند
ارزیاب پیامد و ارائه دهندگان مراقبت در مطالعه ما کورسازی خواهند شد و از گروه بیمارانی که ارزیابی نتایج درمان آنها انجام می شود، اطلاعی ندارند.
ارزیاب پیامد و ارائه دهندگان مراقبت در مطالعه ما کورسازی خواهدخواهند شد و از گروه بیمارانی که ارزیابی نتایج درمان آنها را انجام می دهدشود، نمی دانداطلاعی ندارند.
Grip strengthDisabilities of Arm, Shoulder & Hand score
قدرت مشت کردن
امتیاز ناتوانی های بازو، شانه و دست
قدرت مشت کردنامتیاز ناتوانی های بازو، شانه و دست
Examination
Quick-DASH questionnaire
ExaminationQuick-DASH questionnaire
معاینه
پرسشنامه کوئیک دش
معاینهپرسشنامه کوئیک دش
Intervention groups
#1
Text message and tutorial video links
Intervention group: patients in this group will receive text messages and video links about postoperative care for 12 weeks at no cost. The intervention will be provided in addition to usual care provided to all patients with flexor tendon injury after surgery.
Text messageIntervention group: patients in this group will receive text messages and tutorial video links about postoperative care for 12 weeks at no cost. The intervention will be provided in addition to usual care provided to all patients with flexor tendon injury after surgery.
پیام کوتاه و تارنمای فیلم آموزشی
گروه مداخله: پیام کوتاه و فیلم آموزشی در رابطه با مراقبت بعد از عمل به مدت دوازده هفته بصورت رایگان دریافت خواهند کرد. مداخله پیام کوتاه به علاوه درمان مراقبت معمولی که به تمام بیماران دچار آسیب تاندون دست پس از ترمیم میشود، ارسال می شود.
گروه مداخله: پیام کوتاه و تارنمای فیلم آموزشی در رابطه با مراقبت بعد از عمل به مدت دوازده هفته بصورت رایگان دریافت خواهند کرد. مداخله پیام کوتاه به علاوه درمان مراقبت معمولی که به تمام بیماران دچار آسیب تاندون دست پس از ترمیم میشود، ارسال می شود.
#2
empty
Rehabilitation
rehabilitaion
empty
Control group: patients will receive the usual care provided to all patients with flexor tendon injury after surgery.
Control group: patients will receive the usual care provided to all patients with flexor tendon injury after surgery.
empty
گروه کنترل: درمان مراقبت معمولی که به تمام بیماران دچار آسیب تاندون دست پس از ترمیم میشود، دریافت می کنند.
گروه کنترل: درمان مراقبت معمولی که به تمام بیماران دچار آسیب تاندون دست پس از ترمیم میشود، دریافت می کنند.
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Khoshrounejad Farnaz
Full name of responsible person - Persian: فرناز خوشرونژاد
Position - English: Master Student in Medical Informatics/Student
Position - Persian: دانشجو کارشناسی ارشد
Latest degree: bachelor
Area of specialty/work: 9
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Medical Informatics, Faculty of Medicine of Mashhad
Street address - Persian: دانشکده پزشکی مشھد- گروه انفورماتیک پزشکی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 13944-91388
Phone: +98 51 3840 8265
Mobile: +98 936 854 3394
Fax:
Email: khoshrounf941@mums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Khoshrounejad Farnaz
Full name of responsible person - Persian: فرناز خوشرونژاد
Position - English: Master Student in Medical Informatics/Student
Position - Persian: دانشجو کارشناسی ارشد
Latest degree: bachelor
Area of specialty/work: 9
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Department of Medical Informatics, Faculty of Medicine of Mashhad
Street address - Persian: دانشکده پزشکی مشھد- گروه انفورماتیک پزشکی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 13944-91388
Phone: +98 51 3840 8265
Mobile: +98 936 854 3394
Fax:
Email: Khoshrounf941@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Khoshrounejad Farnaz Full name of responsible person - Persian: فرناز خوشرونژاد Position - English: Master Student in Medical Informatics/Student Position - Persian: دانشجو کارشناسی ارشد Latest degree: bachelor Area of specialty/work: 9 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Department of Medical Informatics, Faculty of Medicine of Mashhad Street address - Persian: دانشکده پزشکی مشھد- گروه انفورماتیک پزشکی City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 13944-91388 Phone: +98 51 3840 8265 Mobile: +98 936 854 3394 Fax: Email: khoshrounf941Khoshrounf941@mums.ac.ir Web page address:
Sharing plan
empty
There is no further information
There is no further information
empty
اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
Protocol summary
Study aim
The main purpose of this study is to survey the effect of sending SMS and educational video link on the treatment outcomes regarding the range of motion of damaged fingers, grip strength and disability of hand as well as VAS score, MAYO score, and PRWE score on the patients with flexor tendon injuries.
Design
This randomized controlled trial (RCT) study is a 12-weeks, two-arm, parallel RCT to evaluate the effectiveness of a text message-based intervention, on primary and secondary outcomes of patients with flexor tendon injury after repair. Forty patients will be randomized in a 1:1 ratio to either the intervention group or the control group using an online random number generator and the sequence will be concealed in sequentially numbered sealed envelopes.
Settings and conduct
setting: Imam Reza Hospital in Mashhad
The study is randomized, one blinded, parallel and in a single center
Participants/Inclusion and exclusion criteria
Main inclusion criteria: Patients with flexor tendon injuries after repair
Exclusion criteria: Patients who have tendon injury with fracture
Intervention groups
Patients who are underwent flexor tendon repair in the intervention groups will receive text messages about postoperative care for 12 weeks at no cost the day after the patient is discharged from the hospital in addition to usual care.
Patients in the control group will receive only usual care.
Main outcome variables
Patient Rated Wrist Evaluation score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170731035411N1
Registration date:2017-12-14, 1396/09/23
Registration timing:prospective
Last update:2019-09-09, 1398/06/18
Update count:1
Registration date
2017-12-14, 1396/09/23
Registrant information
Name
Farnaz Khoshrounejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 8265
Email address
khoshrounf941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Mashhad University of Medical Sciences
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of text message and educational videos on treatment outcomes of hand disability of patients with flexor tendon injuries
Public title
The effect of text message and educational videos on patients with tendon injuries
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients who have flexor tendon injury with no fracture
patients who are underwent flexor tendon repair
Patients who have a cell phone
Exclusion criteria:
Patients who do not agree to continue their cooperation
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization is simple individual randomization. We use a website for the random sequence using an online random number generator. A member of the research team will conceal the assignment of subjects to each group in sequentially numbered opaque, sealed envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessor and care providers will be blinded in our study and they will not know the group of patients that their outcomes will be evaluated.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of Research of Mashhad University of Medical Sciences
Street address
Deputy of Research of Mashhad University of Medical Sciences, Faculty of Medicine, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2017-08-23, 1396/06/01
Ethics committee reference number
IR.MUMS.fm.REC.1396.247
Health conditions studied
1
Description of health condition studied
Hand flexor tendon injuries
ICD-10 code
S66.1
ICD-10 code description
Injury of flexor muscle, fascia and tendon of other and unspecified finger at wrist and hand level
Primary outcomes
1
Description
Patient Rated Wrist Evaluation score
Timepoint
sixth week and twelfth week after the start of the intervention
Sixth week and twelfth week after the start of the intervention
Method of measurement
Visual Analogue Scale
2
Description
Mayo Wrist Score
Timepoint
Sixth week and twelfth week after the start of the intervention
Method of measurement
Checklist
3
Description
GRIP strength
Timepoint
Sixth week and twelfth week after the start of the intervention
Method of measurement
ًًhydraulic hand dynamometer
4
Description
Disabilities of Arm, Shoulder & Hand score
Timepoint
Sixth week and twelfth week after the start of the intervention
Method of measurement
Quick-DASH questionnaire
Intervention groups
1
Description
Intervention group: patients in this group will receive text messages and video links about postoperative care for 12 weeks at no cost. The intervention will be provided in addition to usual care provided to all patients with flexor tendon injury after surgery.
Category
Rehabilitation
2
Description
Control group: patients will receive the usual care provided to all patients with flexor tendon injury after surgery.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Saeed eslami hasan abadi
Street address
Deputy of Research of Mashhad University of Medical Sciences, Faculty of Medicine, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3882 7049
Email
khoshrounf941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar SaberMoghadam
Street address
Deputy of Research of Mashhad University of Medical Sciences, Faculty of Medicine, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3882 7049
Email
khoshrounf941@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
Khoshrounejad Farnaz
Position
Master Student in Medical Informatics/Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Department of Medical Informatics, Faculty of Medicine of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3840 8265
Fax
Email
Khoshrounf941@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
Eslami Hasan Abadi Saeed
Position
PhD in Medical Informatics
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Department of Medical Informatics, Faculty of Medicine of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3882 7049
Fax
Email
Eslamis@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
Khoshrounejad Farnaz
Position
Master of Student in Medical Informatics/Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Department of Medical Informatics, Faculty of Medicine of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3840 8265
Fax
Email
khoshrounf941@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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