Comparison of plaque index in adolescents with bipolar disorder (BMD) by implementing motivational interviewing technique with traditional oral health education
Design
Randomized, parallel, double-blind clinical trial with 60 patients. The simple randomization method has been used for randomization.
Settings and conduct
First, in both groups, the dental plaque index will be measured using a detector solution. Then, the control group will get routine health training and a month later their dental plaque index will be registered by the same dentist. Case group will participate in 2 PMT sessions at Razi Hospital in Tabriz with an interval of 1 month. Adolescent's dental plaque will be re-evaluated one month after the end of the sessions.
Participants/Inclusion and exclusion criteria
inclusion criteria: suffering bipolar mood disorder; adolescents between the ages of 12 and 18; IQ above 70 adolescents; cooperation and participation of adolescents in training classes; conscious written and oral consent.
exclusion criteria: existence of major psychiatric pathology other than BMD in adolescents; taking other psychiatric medications by adolescents; lack of adolescent cooperation
Intervention groups
Adolescents with bipolar disorder will be divided into case and control groups. The members of the case group will participate in 2 CBT training sessions, and the members of the control group will be given the usual health training, such as the correct application of the brushing technique.
Main outcome variables
The main consequence is the Adolescent's plaque index, which will be measured by the detector solution before and after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210822052251N2
Registration date:2022-07-03, 1401/04/12
Registration timing:prospective
Last update:2022-07-03, 1401/04/12
Update count:0
Registration date
2022-07-03, 1401/04/12
Registrant information
Name
Neda Yasamineh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 4991
Email address
yasamineh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-11, 1401/04/20
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of motivational interviewing on dental plaque index of adolescentes with bipolar mood disorder
Public title
The effect of motivational interviewing on dental plaque index of adolescentes with bipolar mood disorder
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering bipolar mood disorder
Adolescents in the age range of 12 to 18 years
IQ above 70 adolescents which will be determined by raven test intelligence screening
written informed consent from the parent or legal guardian and oral assent from the adolescent
Cooperation and participation of adolescent in CBT classes
Exclusion criteria:
Use of orthodontic applications
Existence of major psychiatric pathology other than BMD in adolescent
Taking other psychiatric medications by the adolescent
Lack of cooperation of the adolescent
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, The person examining the adolescent's dental plaque index and the person who analyzes the data will not know in which study group the examined people are. Therefore, the study will be double-sided blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2021-12-18, 1400/09/27
Ethics committee reference number
IR.TBZMED.REC.1400.905
Health conditions studied
1
Description of health condition studied
Bipolar mood disorder
ICD-10 code
F31.0
ICD-10 code description
Bipolar affective disorder, current episode hypomanic
Primary outcomes
1
Description
Dental plaque index
Timepoint
Before the intervention and one month after the end of the CBTsessions
Method of measurement
Disclosing solution
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in addition to receiving traditional health education, the intervention group will participate in 2 sessions of oral health education through interviews with an interval of 1 month and will receive motivation with the guidance of the Lental model. Motivational interviews will take approximately 15-20 minutes. Oral health information and instructions will be given to the patient during the motivational interview (depending on the patient). The questionnaire prepared for the study will be used as a title to start the interview. Addressing the five dimensions of Lonthal interview theory, this letter follows the principles of motivation (physicians 'empathy, contradiction of patients' importance and values with their own opinion, and lack of direct argument or confrontation). The questionnaire will consist of five questions: 1- What is dental health for you? 2. What are the factors that contribute to oral health? 3- What are the consequences of dental problems for you in daily life? 4. What kind of oral care do you do for your gums regularly, even daily, and what factors may increase your gum and tooth problems? 5- What treatment methods can you have to restore healthy teeth and gums? Explanations of conversion methods will naturally be considered during the next discussion that will be created (for example, in the brushing test method). After a month, the dentist will make an appointment for an oral examination, and in the second initial session, the dental plaque index will be evaluated and recorded by a physician from a unique grouping, and will be recorded as a new thing according to the amount of plaque reduction during these periods. شد. The motivational interview will address the problems encountered while brushing and creating a feeling of improvement in the patient's use of the disease. After a month, he will be examined again by a dentist who is unaware of the groupings and his dental plaque index will be evaluated and recorded.
Category
Lifestyle
2
Description
Control group: these people will receive routine hygiene training, which includes training to brush with the modified bass technique, flossing, and also showing the mouth using a mirror. After a week, the participants will be examined by a dentist and their dental plaque index will be evaluated and recorded.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital, Tabriz and specialized child and adolescent psychiatric clinics
Full name of responsible person
Gholamreza Nourazar
Street address
Bakeri Blvd., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Email
s.gh.noorazar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samii
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3177 1041
Email
info@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Kamran Delavizbonab
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Golghasht avenue, Daneshgah street