The effect of showing an educational video related to implant surgery on patients anxiety level
Design
We will use the Restricted Randomization method with blocks of six.
The sample size is expected to be 60 people
Settings and conduct
Preparation of educational video
This video is performed by a maxillofacial surgeon and the implant procedure is explained step by step Obtaining informed consent from these patients, randomly dividing patients into two intervention and control groups using random allocation of permuted blocks. An explanation about the research and the process of doing the work, then the completion of the relevant questionnaires by the subjects under study, which will be completed by the patient himself or his companion if they are literate, and by the researcher if they are not literate. For the control group, there is no intervention and the questionnaire is completed only on two occasions For all patients, basic instructions are given regarding the method of implant surgery The educational video will be shown to the intervention group on different days, and two groups will not visit on the same day. The relevant patients are completed The questionnaire is only explained to the patients by the relevant researcher For the control group, only the questionnaire is explained
Participants/Inclusion and exclusion criteria
Patients who are candidates for implant surgery for the first time and do not have a history of previous anxiety and do not have a systemic disease that interferes with implant surgery.
Intervention groups
In this study, an educational film is shown to the intervention group and its effect on the patient's anxiety is evaluated
Main outcome variables
Increase patient anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221114056499N1
Registration date:2022-11-30, 1401/09/09
Registration timing:prospective
Last update:2022-11-30, 1401/09/09
Update count:0
Registration date
2022-11-30, 1401/09/09
Registrant information
Name
Ali Hematian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3333 5914
Email address
hematian_ali@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-21, 1401/09/30
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of showing an educational video related to implant surgery on patients anxiety level
Public title
The effect of showing video on anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for implant surgery
Need implant surgery for the first time
Do not have complete information about implant surgery
In general, the patient should not be anxious
Exclusion criteria:
The presence of systemic diseases that interfere with implant surgery
Having information about implant surgery
Have experience in implant surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced random distribution: Our sample size is 60 people
First, we consider 10 blocks of 6 people (that is, the process of random division is balanced for 6 patients) and from every 6 people who enter a block, we divide them into two groups, A and B, now all the situations that can be 3A and 3B I write to have, which can be 20 cases
We determine the sampling numbers for each of the blocks because each block must have the same chance of selection as the others and the sampling numbers must be the same for all groups.
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 Semnan University of Medical Sciences
Street address
Semnan, Basij Blvd., Central Headquarters of Semnan University of Medical Sciences, Research and Technology Vice-Chancellor
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2022-10-09, 1401/07/17
Ethics committee reference number
IR.SEMUMS.REC.1401.184
Health conditions studied
1
Description of health condition studied
Implant surgery
ICD-10 code
F41.1
ICD-10 code description
Disorders of adult personality and behaviour
Primary outcomes
1
Description
Increase or Decrease anxiety
Timepoint
The level of anxiety is measured immediately before and after the video is shown
Method of measurement
The level of anxiety is measured by the Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: an educational video is shown to this group, and immediately before and after the video is shown, the decrease or increase in the patient's anxiety level is measured by a questionnaire.
Category
Behavior
2
Description
Control group: Control group: only 2 questionnaires are filled for the patient, one in the first stage of cooking and the other before the operation
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan University of Medical Sciences dental clinic
Full name of responsible person
Zahra Amiri
Street address
17 Shahrivar Blvd
City
Semnan
Province
Semnan
Postal code
94431-35187
Phone
+98 23 3332 4700
Email
dent@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ava Nikbin
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 8999
Email
int.relation@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
1
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
Semnan University of Medical Sciences
Full name of responsible person
Ali Hemmatian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Semnan, Valiasr Boulevard, Khormian Alley
City
Semnan
Province
Semnan
Postal code
35196187464
Phone
+98 23 3333 5914
Email
hematian_ali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Hemmatian
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Semnan, Valiasr Boulevard, Khormian Alley
City
Semnan
Province
Semnan
Postal code
3519696464
Phone
0982333335914
Email
hematian_ali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Hemmatian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Semnan, Valiasr Boulevard, Khormian Alley
City
Semnan
Province
Semnan
Postal code
319686464
Phone
+98 23 3333 5914
Email
hematian_ali@yahoo.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