Effects of physiotherapy with and without bonding on prevention of deep vein thrombosis in women undergoing total abdominal hysterectomy
Design
This randomized clinical trial was conducted in parallel with no control group. On the other hand, patients will be divided into control and intervention groups using SPSS software and participants will be blind during the study.
Settings and conduct
Patients will receive their intervention after random allocation in Tabriz Imam Reza Hospital. The person analyzing the data is of a clustered type and is blind during the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate hysterectomy by total abdominal method
Exclusion criteria: Physiotherapy received in the last month
Intervention groups
Patients will receive the intervention after random assignment in both groups. The physiotherapy group will receive physiotherapy three times (once daily) prior to surgery, and the physiotherapy + bandage group will be closed to the legs after physiotherapy throughout the day.
Main outcome variables
Deep vein thrombosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N13
Registration date:2019-12-04, 1398/09/13
Registration timing:prospective
Last update:2019-12-04, 1398/09/13
Update count:0
Registration date
2019-12-04, 1398/09/13
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of physiotherapy with and without bonding on prevention of deep vein thrombosis in women undergoing total abdominal hysterectomy
Public title
Effects of physiotherapy with and without bandage on prevention of deep vein thrombosis in hysterectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Total abdominal hysterectomy
Exclusion criteria:
Performing physiotherapy in one month
Age
From 35 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The dice throw method will be used for randomization. The even number represents the individual in the intervention group and the individual number represents the individual in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.TBZMED.REC.1397.1059
Health conditions studied
1
Description of health condition studied
Deep vein thrombosis
ICD-10 code
I82.40
ICD-10 code description
Acute embolism and thrombosis of unspecified deep veins of lower extremity
Primary outcomes
1
Description
Deep vein thrombosis
Timepoint
Before intervention and after surgery
Method of measurement
Blood tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the physiotherapy group will receive one day of lower extremity physiotherapy three days before surgery. Physiotherapy will be performed by a skilled physiotherapist at Imam Reza Hospital. Specialized tests for the diagnosis of deep vein thrombosis will be performed before the intervention and after surgery. The data analyzer will be blind during the study.
Category
Prevention
2
Description
Intervention group: Patients in this group will be bandaged after physiotherapy and will remain closed throughout the day. This will be done by the researcher. Blood tests for diagnosis of deep vein thrombosis will be performed before and after surgery. The intervention will be at Imam Reza Hospital in Tabriz.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dara Alvandfar
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 21 3335 5921
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Sina Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
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