1.To assess the early Complications for patient after rhinoplasty before the application of cooling face.
2.To determine the effect of the application of cooling face on early complication for patient after rhinoplasty.
3.To compare the effect of cooling face and traditional cooling care on early complication for patients after rhinoplasty.
Design
A parallel, Randomized control trial design, to determine the effect of the intervention (Cooling Face) on early complication (pain, edema and ecchymosis).
Settings and conduct
AL-kindi and AL-Wasiti Teaching Hospital at Surgical Ward.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who undergoing surgical rhinoplasty, agree to share in the study. who are 18-60 years old at the time of the data collection phase
Exclusion criteria: Involvement with any other ongoing studies. Medically diagnosed with psycho-mental diseases. Patients with a previous surgical rhinoplasty procedure, patients with bleeding disorders as their condition interfere with the degree of intraoperative bleeding.
Intervention groups
In the intervention group, to evaluate the pain using Numeric Pain Rating Scale, where the researcher asks about the pain ratio of 0-10, edema and bruises using the Modified Surgeon Periorbital Rating of Edema and Ecchymosis questionnaire adjusted for edema and ecchymosis. The measurement is performed by the researcher records the edema ratio of 1-4, according to the edema ratio as well as bruises of 0-3, according to the bruise ratio around the eye before the intervention, then gives cryotherapy using (Cooling Face) applied for 10 to 15 minutes every half hour, then reassesses the pain edema and ecchymosis will occur after 4 hours and repeated in 24 hours for two groups.
Main outcome variables
Relief and reduced early complication (pain edema and ecchymosis) after rhinoplasty
General information
Reason for update
Acronym
A Randomized controlled trial (ARCT)
IRCT registration information
IRCT registration number:IRCT20230310057672N2
Registration date:2024-03-23, 1403/01/04
Registration timing:prospective
Last update:2024-03-23, 1403/01/04
Update count:0
Registration date
2024-03-23, 1403/01/04
Registrant information
Name
Alaa Jawad
Name of organization / entity
University of Baghdad/College of Nursing
Country
Iraq
Phone
+964 1 521 1494
Email address
alaaj@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-02, 1403/01/14
Expected recruitment end date
2024-05-07, 1403/02/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cooling Face Therapy on Recovery from Early Complications for Patients after Rhinoplasty: A Randomized Controlled Trial
Public title
The Effect of Cooling Face Therapy on Recovery from Early Complications for Patients after Rhinoplasty
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients who undergoing surgical rhinoplasty, agree to share in the study. who are 18-60 years old at the time of the data collection phase
Exclusion criteria:
Involvement with any other ongoing studies. Medically diagnosed with psycho-mental diseases.
Patients with a previous surgical rhinoplasty procedure, patients with bleeding disorders as their condition interfere with the degree of intraoperative bleeding and affect the results as well as diabetic patients.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In order to maintain a transparent & scientific-based randomization process, simple randomization will be used in assigning participants (rhinoplasty), to intervention (cooling face) & control ( traditional cooling) group, assuming that each participant has an equal chance of being assigned to any group. The simple randomization procedure would involve throwing a dice (eg, below & equal to 3 = control, over 3 = intervention). No allocation concealment will be carried out.
Blinding (investigator's opinion)
Single blinded
Blinding description
To achieve single blind in this trial, the participant is kept blinded to their group assignment (Intervention and control group) throughout the study. The data collector administers the assigned intervention group (Cooling Face) and Control group (Traditional Cooling) without revealing the participant's group assignment. The researcher retains knowledge of group allocation to ensure single blind. Interventions are randomized, and the early complication (pain, edema and ecchymosis) to assessment without knowing the type of maneuvers received, ensuring that participants' expectations do not influence the results. These procedures reduce the influence of prior expectations and ensure an effective study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Approval Committee, at the College of Nursing
The primary outcome variable that may relieve or reduce the early complication (pain, edema and ecchymosis) after Rhinoplasty
Timepoint
The clinical intervention of the experiment is carried out 30 minutes after rhinoplasty for patients , the results of the intervention are shown to reduce the intensity of pain, edema and ecchymosis from the first day after surgery to the second day. The assesses the pain, edema and ecchymosis facial will occur after 4 hours and repeated in 24 hours for two groups.
Method of measurement
Measurement method before and after clinical intervention using Numeric Pain Rating Scale (NPRS) to measure facial pain (Alghadir, A. H., Anwer, S., & Iqbal, Z. A. 2016). Modified Surgeon Periorbital Rating of Edema and Ecchymosis (SPREE) questionnaire to measure edema and ecchymosis (Kara, CO. and Gökalan, 1999).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After the patient has had a rhinoplasty and is in the surgical ward, waiting to removing from anesthesia, and showing signs of patient consciousness, the researcher starts by assessing facial pain by using numeric pain rating scale (NPRS) and edema and ecchymosis by using modified surgeon periorbital rating of edema and ecchymosis (SPREE) questionnaire before doing the intervention, then gives the cooling therapy by using Face Cold (FC), applied for 10 to 15 minutes every half hour then re-assesses pain, edema and ecchymosis after 4 hours and repeated at 24 hours.
Category
Treatment - Other
2
Description
Control group: Traditional Cooling (TC) was applied, which consisted of ice packs placed at the same time as the intervention group ( 10 to 15 minutes every half hour, then reassesses the facial pain, edema and ecchymosis will occur after 4 hours and repeated in 24 hours).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgical ward/ AL- kindi and AL-Wasiti Teaching Hospital.
Full name of responsible person
Alaa Jawad Kadhim, Maysam saddun
Street address
Baghdad, Street 729
City
Baghdad
Postal code
10001
Phone
+964 1 415 0076
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
College of Nursing / University of Baghdad
Full name of responsible person
Professor. Wissam Jabbar Qasim, PhD. Dean
Street address
Bab AL-Muadum campus
City
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://en.conursing.uobaghdad.edu.iq/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The authors of the trial are the funding source
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
University of Baghdad/College of Nursing
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Baghdad, Street 729
City
Baghdad
Province
Alrusafa
Postal code
10045
Phone
+964 770 352 0314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://mapcarta.com/30678848
Person responsible for scientific inquiries
Contact
Name of organization / entity
College of Nursing/ University of Baghdad
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical and Surgical Nursing
Street address
Baghdad, Street 729
City
Baghdad
Province
Alrusafa
Postal code
10045
Phone
+964 770 352 0314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://mapcarta.com/30678848
Person responsible for updating data
Contact
Name of organization / entity
College of Nursing / University of Baghdad
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical and Surgical Nursing
Street address
Baghdad, Street 729
City
Baghdad
Province
Alrusafa
Postal code
10045
Phone
+964 770 352 0314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://mapcarta.com/30678848
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.
When the data will become available and for how long
God willing, once finishing the process of data collection, analysis, and successful publishing of the manuscript, all the related files will become available for four months after the publications, after you are approved to register on the Iranian clinical trials website
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission and acknowledging his contribution
From where data/document is obtainable
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: alaaj@conursing.uobaghdad.edu.iq
What processes are involved for a request to access data/document
N/A
Comments
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors.