Determining the effect of head position on ecchymosis and swelling after rhinoplasty
Design
clinical trial ,with control and intervention groups ,single blinded , Balanced Block Randomization
Settings and conduct
Facial plastic surgery clinic in patients undergoing rhinoplasty; in the intervention group,the position of the head was kept 40 to 60 degrees higher after surgery, and then both groups will be followed up for one week.
In intervention group will performed head position; in the form of head elevation 40-60 degrees.(on the second day after rhinoplasty until the seventh day)
control groups: no intervention
Main outcome variables
ecchymosis ; swelling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201005048938N1
Registration date:2020-10-30, 1399/08/09
Registration timing:registered_while_recruiting
Last update:2020-10-30, 1399/08/09
Update count:0
Registration date
2020-10-30, 1399/08/09
Registrant information
Name
Halime ناصری
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3764 4622
Email address
ftm.naseri@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-15, 1399/07/24
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Head position on swelling and ecchymosis after Rhinoplasty operation on patient who visited surgery clinics
Public title
The effect of Head position on swelling and ecchymosis after Rhinoplasty operation
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
having conscious satisfaction with the objectives of the research
lack of underlying disease including coagolation disorder and cardiopulmonary disease
dont take contraceptive agent and aspirin before surgery
Exclusion criteria:
Cardiopulmonary disease
Coagolopathy disease
Using contraceptive agent and ASA before Rhinoplasty
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
balanced Block Randomization with 10 balanced block. patients randomly will be allocated into 2 groups that each group will include 60 people.
we included 120 patients (who 60 of them recipient intervention (head elevation) and 60 each other have not intervention); there will be 5 cards in each group; So in each groups ,10 patients are assigned as midwives.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to eliminate the bias caused by the knowledge of the researcher and clinical evaluator and data analyzer and its possible effect on the research result, this study performed single blind; And the data evaluator and the person analyzing data do not know that patients are constantly in intervention or control groups.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Science
Street address
dr Hesabi Blvd, university of Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816746557
Approval date
2020-07-25, 1399/05/04
Ethics committee reference number
IR.ZAUMS.REC.1399.157
Health conditions studied
1
Description of health condition studied
edem and ecchymosis after rhinoplasty
ICD-10 code
Z41
ICD-10 code description
Encounter for procedures for purposes other than remedying health state
Primary outcomes
1
Description
edem
Timepoint
evaluating of periorbital edema in 2th day after intervention in 3,5,7
Method of measurement
standard four-point scoring tool
2
Description
Ecchymosis
Timepoint
evaluation of periorbital ecchymosisin 2th day after intervention in 3,5,7
Method of measurement
standard four-point scoring tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: head elevation after rhinoplasty of 40 to 60 degrees , which will be recommended to patients by a cosmetic surgeon. Keeping the head high is one of the most common post-rhinoplasty care that is given to patients by cosmetic surgeons. Decreased blood flow and reduce inflammation that decrease edema and ecchymosis . This procedure will be performed for a week in patients whose head position is 40-60 degrees when holding the head while lying down and sleeping.
Category
Treatment - Other
2
Description
Control group: have not intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa and Noor surgery clinics in zahedan
Full name of responsible person
Dr Mohammad Zare
Street address
Shafa surgery clinic ,Khayam aven,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817643429
Phone
+98 54 3342 7999
Email
shafaclinic@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.NoorMohammad Bakhshani
Street address
Zahedan University of Medical Sceince
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5756
Email
admin&finance@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?