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Evaluation of the Effect of light emitting diodes therapy (LEDT) to Reduce the Recovery Period of Rhinoplasty

Protocol summary

Study aim
If significant effectiveness is observed, low power laser can be a low cost and effective way to reduce the duration of patient involvement after rhinoplasty.
Design
A clinical trial with a control group, with parallel, randomized groups, on 20 patients. Data are analyzed using SPSS software (version 26). Quantitative variables with mean and variance and qualitative variables with frequency and percentage are described. Independent t-test, Mann-Whitney and chi-square tests are used to compare the two groups. Paired t-test, Wilcoxon and Mac Nemar tests are used for group comparison. Significance level less than 0.05 is considered
Settings and conduct
In a randomized blinded clinical trial, patients referred to the hospital for rhinoplasty are evaluated for inclusion criteria. Treatment procedure in the case group of 660 nm low power diode laser device with a dose of 4 joules per square centimeter, continuous 10 sessions Evaluations are performed once before assigning patients to treatment groups and once at the end of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: age range between 30 to 70 years and complete satisfaction to participate in the study. with diabetes, pregnant and lactating women, photosensitivity, under 30 years and over 70 years, history of seizures and secondary hypertension are excluded from the study.
Intervention groups
660 nm low power diode laser device treatment procedure with a dose of 4 joules per square centimeter, continuous 10 sessions every other day for 20 days Both the control and case groups are treated routinely. Treatment in this group will also be given by the same doctor.
Main outcome variables
Age; sex; underlying diseases; Disease duration; Laser power; Laser wavelength; Frequency of irradiation; Duration of bruising; Duration of pain relief; Duration of swelling reduction; Duration of wound healing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20111121008146N36
Registration date: 2021-11-24, 1400/09/03
Registration timing: registered_while_recruiting

Last update: 2021-11-24, 1400/09/03
Update count: 0
Registration date
2021-11-24, 1400/09/03
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of light emitting diodes therapy (LEDT) to Reduce the Recovery Period of Rhinoplasty
Public title
Evaluation of the Effect of light emitting diodes therapy (LEDT) to Reduce the Recovery Period of Rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range between 30 and 70 years Complete consent to participate in the study
Exclusion criteria:
Diabetes Pregnant and lactating Sensitivity to light Under 30 and over 70, History of seizures and hypertension in the disease (secondary hypertension)
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
All patients are divided into case and control groups according to the table of random numbers with a ratio of 1: 1. The assigned group of individuals is placed one after the other in dark envelopes
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 in Biomedical Research of Shahid Beheshti University of medical sciences
Street address
Daneshjoo Blvd, Yaman street
City
tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-09-19, 1400/06/28
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.355

Health conditions studied

1

Description of health condition studied
Rhinoplasty
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain
Timepoint
After surgery, Three days later, one week later, ten days later and 15 days later
Method of measurement
VAS

2

Description
Ecchymosis
Timepoint
After surgery, Three days later, one week later, ten days later and 15 days later
Method of measurement
Based on the review of daily photos, we divide them into the following categories: no ecchymosis, mild ecchymosis, moderate and severe

3

Description
Swelling
Timepoint
After surgery, Three days later, one week later, ten days later and 15 days later
Method of measurement
Based on the review of daily photos, we divide them into the following categories: no swelling, mild, moderate and severe swelling

4

Description
Wound healing
Timepoint
After surgery, Three days later, one week later, ten days later and 15 days later
Method of measurement
Based on the comparison of incision wounds

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 660 nm low power diode laser device treatment procedure with a dose of 4 joules per square centimeter, continuous 10 sessions every other day for 20 days
Category
Treatment - Other

2

Description
Control group: Patients in this group are treated routinely. Treatment in this group will be given by the same doctor
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Central City Clinic
Full name of responsible person
Behrouz Barikbin
Street address
No. 20 and 24,Valinejad St,Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
1969853831
Phone
+98 21 8888 4425
Email
Dr.barikbin@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sadi Banar
Street address
Laser Application in Medical Sciences Research Center, Shohadaye-Tajrish Educational Hospital, Tajrish Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934370
Phone
+98 21 2271 8021
Email
laser.cntr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Barati
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Laser Application in Medical Sciences Research Center, Shohadaye-Tajrish Educational Hospital, Tajrish Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934370
Phone
+98 21 2271 8021
Email
laser.cntr@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Barati
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Laser Application in Medical Sciences Research Center, Shohadaye-Tajrish Educational Hospital, Tajrish Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934370
Phone
+98 21 2271 8021
Email
laser.cntr@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Barati
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Laser Application in Medical Sciences Research Center, Shohadaye-Tajrish Educational Hospital, Tajrish Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934370
Phone
+98 21 2271 8021
Email
laser.cntr@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
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers and Rhinosurgeons
Under which criteria data/document could be used
Email the corresponding author and earn permission
From where data/document is obtainable
Email the corresponding author
What processes are involved for a request to access data/document
Email the corresponding author, the authors' meeting, send the data at your discretion
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