Evaluation the effectiveness of psychologic intervention (cognitive-behavioural) on dental anxiety during pulpotomy in 7-10 years old children
Design
Randomised controlled clinical trial with double blinded and a parallel group design of 30 patient enrolled between october and march2018
Settings and conduct
In first session the child undergo prophylaxis and fluoride therapy in dental school clinic and child with clinical dental anxiety diagnosis according to Modified Child Dental Anxiety Scale enter to study .Child with random allocation is assigned in two intervention or control groups.
In the intervention group ,the cognitive- behavioural interventions is taught to the child .Also parent are provided with a video recording of a cooperative child under pulpotomy for showing at home to their child.
In control group routine behavioral guidance techniques are applied.
In second session ,pulpotomy is done and child cooperation level during treatment is scored with Venham Clinical Cooperation Scale.
After pulpotomy treatment ,again ,child clinical anxiety level is determinated.
Participants/Inclusion and exclusion criteria
7-10 years old children with one mandibular primary molar teeth need pulpotomy,without mental and systemic and general anxiety problems,without previous dental treatment experience ,with clinical dental anxiety
Exclusion criteria:The child`s inability to learn techniques
Intervention groups
Cognitive- behavioural interventions consist of education the Benson’s relaxation technique (breathing with benson technique, gradual muscles expansion and constriction/combination of these two technique)/imagination and distraction.
Also parent are provided with a video recording of a cooperative child under pulpotomy for showing at home to their child .
In control group rotine behavioral guidance techniques are applied
Main outcome variables
Child anxiety
Child cooperation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181024041441N1
Registration date:2019-01-18, 1397/10/28
Registration timing:registered_while_recruiting
Last update:2019-01-18, 1397/10/28
Update count:0
Registration date
2019-01-18, 1397/10/28
Registrant information
Name
Marziyeh Shokravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 3064
Email address
m.shokravi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-20, 1397/07/28
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectiveness of psychologic intervention (cognitive-behavioural) on dental anxiety during pulpotomy in 7-10 years old children
Public title
Evaluation the effectiveness of psychologic intervention (cognitive-behavioural) on dental anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
7-10 years old children
Child with no mental and systemic and genetic disturbance
Child with no previous dental treatment experience
Child with no anxiety disorder according to SCARED scale
Presence of clinical dental anxiety according to MCDAS scale in child
Presence one mandibular primary molar tooth that need to pulpotomy and inferior alveolar nerve block injection in child
Exclusion criteria:
Child inability for psychologic intervention learning
Age
From 7 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
persons areare assigned to the control and intervention groups with simple randomisation according to statistical software( Random Allocation Software).
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome is evaluated by a person othr than the clinical investigator and caregiver in random numbers and she is blind to the intervention received.the results of each sample are delivered to the analyzer in the form of a number.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin University of medical sciences,Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
15315_34199
Approval date
2018-10-17, 1397/07/25
Ethics committee reference number
IR.QUMS.REC.1397.161
Health conditions studied
1
Description of health condition studied
dental anxiety in 7-10 years old children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
child dental anxiety level
Timepoint
Before intervention and again one week after intervention
Method of measurement
Modified child dental anxiety scale
Secondary outcomes
1
Description
Child cooperation leve during pulpotomy
Timepoint
One week after intervention according to child behavior recording video during pulpotomy
Method of measurement
Venhem Clinical Cooperation Rating Scale
Intervention groups
1
Description
Psychologic intervention (cognitive- behavioral) that is taught to the child in three sessions including following stages: First session:Comminucation establishment with the child /Giving explanation about the treatment procedure and its effects/ introducing the treatment environment/brushing and fluorid therapy Second session :Training the child about the Benson’s relaxation technique (gradual muscles relaxation and constriction/combination of these two techniques /breathing technique)/ imagination and distraction training Finally: Parents are provided with a video recording of a cooperative child under pulpotomy to play at home for their child. The treatment appointment is planned one week later and 30 minutes before the treatment begins, intervention stages are practiced again with the child. During the treatment, routine behavioral guidance techniques such as tell-show-do are applied.
Category
Behavior
2
Description
Control group: During treatment routine behavioral guidance techniques such as tell- show- do are applied.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences, School of Dentistry,Department of Pediatric Dentistry
Full name of responsible person
Marziyeh Shokravi
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
15315_34199
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
m.shokravi@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 7006
Email
apeymani@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Marziyeh Shokravi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
15315_34199
Phone
(+98)(28)(33336001_5)
Email
M.shokravi@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Marziyeh Shokravi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
15315_34199
Phone
(+98)(28)(33336001_5)
Email
M.shokravi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Marziyeh Shokravi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
15315_34199
Phone
(+98)(28)(33336001_5)
Email
M.shokravi@qums.ac.ir
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
No - There is not 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
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available