The effect of psycological pretreatment on anxiety level in patients undergoing dental surgery
Design
This study included 30 subjects in both control and intervention groups. Patients will randomly be divided into two groups. Simple randomization will be performed by using a random number table. The trial is phase 2-3
Settings and conduct
This study will be performed at the Dental Clinic of Ahvaz Jundishapur University of medical sciences with no blinding.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: age 18-80 years؛ Able to speak Persia؛ the ability to communicate verbally؛ a consent to enter the scheme
Exclusion Criteria: mental retardation, distinctive physical problems that interfere consultation, history of major psychiatric disorders, dementia
Intervention groups
Intervention group: Pre-treatment training will be performed for 20 minutes before the procedure begins and in a separate room in the dental room. Training includes psychological preparation that includes behavioral control, cognitive control, and information control.
Control group: The control group will be given a pamphlet on the general informations (about fruits and vegetables).
Main outcome variables
State Anxiety
Trait Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161228031626N4
Registration date:2019-11-02, 1398/08/11
Registration timing:registered_while_recruiting
Last update:2019-11-02, 1398/08/11
Update count:0
Registration date
2019-11-02, 1398/08/11
Registrant information
Name
Hatam Boostani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
tabibi.y@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of psycological pretreatment on anxiety level in patients undergoing dental surgery
Public title
The effect of psycological pretreatment on anxiety level in patients undergoing dental surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-80years
Able to speak Persian
the ability to communicate verbally
a consent to enter the scheme
Exclusion criteria:
mental retardation
An obvious physical problem
A history of major psychiatric disorders
Dementia
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done by random number table
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
157945-6135
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.AJUMS.REC.1397.349
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
State Anxiety
Timepoint
Before intervention- After intervention
Method of measurement
Spielberg questioner
Secondary outcomes
1
Description
Trait Anxiety
Timepoint
Before intervention- After intervention
Method of measurement
Spielberge questioner
Intervention groups
1
Description
Intervention group: A Spielberg questionnaire for measuring level of anxiety will be use and fill out by patients. Pre-treatment training will be provided for 20 minutes before the procedure begins and in a separate room in the dental room.Behavioral control includes the ability to take action to reduce stress, such as relaxation and distraction. Cognitive control involves the ability to use thought processes and strategies, such as thinking about the positive outcome of an event.
Category
Behavior
2
Description
Control group: The control group will be given a pamphlet on the general informations (about fruits and vegetables)
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh Davoodi Koorani
Street address
Ahvaz,Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd,
City
Ahvaz
Province
Khouzestan
Postal code
157945-6135
Phone
+98 61 3374 3038
Email
f.davoodi.k@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
5794-613571
Phone
+98 61 3374 3038
Email
badavi.m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hatam Boostani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Golestan Hospital ,Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
5794-613571
Phone
+98 61 3374 3038
Email
boostani-h@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Siroos Pak seresht
Position
Assistant Professorاستادیار
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Golestan hospital,Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
5794-61357
Phone
+98 61 3374 3038
Email
paks392003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Davoodi Koorani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Golestan Hospital,Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
5794-61357
Phone
+98 61 3374 3038
Email
f.davoodi.k@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
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