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
Main inclusion criteria: Patients having a cell phone
Main exclusion criteria: Patients who do not agree to continue their cooperation
Settings and conduct
setting: Imam Reza Hospital in Mashhad
The study is randomized, one blind, parallel and in a single center
Participants/Inclusion and exclusion criteria
Participants: Patients with flexor tendon injuries
Intervention groups
Intervention: SMS and educational video link
Main outcome variables
Main outcome: Dash 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:2017-12-14, 1396/09/23
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
2017-12-22, 1396/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
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:
Main inclusion criteria: Patients who have a cell phone
Exclusion criteria:
Main exclusion criteria: Patients who do not agree to continue their cooperation
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
individual randomization
The tool we use in randomization: sealed envelops
We use www.randomization.com website for random sequence
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessor will be blinded in our study and he will not know the group of patients that their outcomes are evaluating
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
DASH score
Timepoint
sixth week and twelfth week after the start of the intervention
Method of measurement
DASH questionnaire
Secondary outcomes
1
Description
VAS score
Timepoint
Sixth week and twelfth week after the start of the intervention
Method of measurement
VAS questionaire
2
Description
Mayo score
Timepoint
Sixth week and twelfth week after the start of the intervention
Method of measurement
Checklist
3
Description
PRWE
Timepoint
Sixth week and twelfth week after the start of the intervention
Method of measurement
ًًQuestionnaire
4
Description
Grip strength
Timepoint
Sixth week and twelfth week after the start of the intervention
Method of measurement
Examination
Intervention groups
1
Description
Text message and tutorial video links
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