Assessing the effect of preoperative education on anxiety and body image concern in patients undergoing rhinoplasty surgery
Design
Clinical trial, with parallel control and intervention groups, randomized. Odd and even cards are used for randomization.
Settings and conduct
Selected hospitals of Isfahan (Alzahra, Kashani, Amin).
Participants/Inclusion and exclusion criteria
Age between 18-40, having smartphone, no history of anti-anxiety medication use, non participation in previous educational program
Intervention groups
Control group receive routine care. For the intervention group, two clips containing simplified surgical techniques and care before and after surgery will be sent to Eta. Researcher and rhinoplasty surgeon at Eta will answer patient question. Anxiety is checked twice and body image concern is checked three times in both group.
Main outcome variables
Anxiety
Body image concern
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230701058633N1
Registration date:2023-07-17, 1402/04/26
Registration timing:prospective
Last update:2023-07-17, 1402/04/26
Update count:0
Registration date
2023-07-17, 1402/04/26
Registrant information
Name
Fatemeh Moshtaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3753 2428
Email address
moshtaghi.f75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of effect of preoperative education on anxiety and body image concern in patients undergoing rhinoplasty surgery
Public title
Effect of education on anxiety in patients undergoing rhinoplasty surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Age range between 18 and 40
Candidate for cosmetic rhinoplasty surgery
Having smartphone
Capability for correct use programs such as Ita
Good language communication and ability to understand
Elementary literacy level or higher
Exclusion criteria:
History of previous surgery and anesthesia
Previous psychiatric illness
Receiving anti-anxiety medication before surgery
History of anti-anxiety medication use
Using complementary medicine methods one week before surgery
Serious illness in body systems
Previous participation in preoperative educational program
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
An equal number of even and odd codes are written to reach the required number of samples. Then, each person with the entry criteria is told to take one of cards. If she/he takes a card with an even code, she/he will be in the intervention group, and if she/he takes a card with an odd code, she/he will be 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 Isfahan University of Medical Sciences
Street address
Operating room department, nursing and midwifery faculty, Isfahan University of Medical Sciences, Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-05-24, 1402/03/03
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.030
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
Body image concern
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety scores
Timepoint
Measurement of anxiety scores: before intervention, after intervention (before surgery)
Method of measurement
Speilberger State-Trait Anxiety Inventory
2
Description
Body image concern scores
Timepoint
Measurement of body image concern scores: before intervention, after intervention (before surgery), 1 month after surgery
Method of measurement
Littleton Body Image Concern Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: two video clips will be sent to patients. One clip will contain the simplified technique of rhinoplasty surgery and the other clip will contain preoperative and postoperative cares. After viewing the clips by patients, the researcher and the rhinoplasty surgeon will be online in Eta on certain days from 8:00 to 10:00 PM and answer the patient questions about the clips.The educational content in the intervention group will include two parts:1.educational module: including information about surgery technique, preoperative cares and management of postoperative complications. 2. answering and solving questions module: presence of researcher and surgeon on certain days to explain the information, answer the questions and correcting patient mistakes.
Category
Other
2
Description
Control group: the people of this group receive training in a way that is routine and specific to each treatment center. The usual method of teaching patients in different medical centers may be as follows: educational brochure, teaching the patient by the relevant surgeon or nurse, ...
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital, Kashani hospital, Amin hospital
Full name of responsible person
Fatemeh Moshtaghi
Street address
Operating room department, nursing and midwifery faculty, Isfahan University of Medical Sciences, Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3753 2428
Email
moshtaghi.f75@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Deputy of research and technology, building number 4, Isfahan University of Medical Sciences, Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Moshtaghi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Surgical technology, operating room
Street address
Operating room department, nursing and midwifery faculty, Isfahan University of Medical Sciences, Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3753 2428
Fax
Email
moshtaghi.f75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Moshtaghi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Surgical technology, operating room
Street address
Operating room department, nursing and midwifery faculty, Isfahan University of Medical Sciences, Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3753 2428
Fax
Email
moshtaghi.f75@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Moshtaghi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Surgical technology, operating room
Street address
Operating room department, nursing and midwifery faculty, Isfahan University of Medical Sciences, Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3753 2428
Fax
Email
moshtaghi.f75@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
Not applicable
Informed Consent Form
No - There is not 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