Effect of coping skill training versus no coping training on pain perception, anxiety and behavior in 3-6 years old children during dental treatment as a clinical trial
Aim of this study is evaluating the effect of coping skill training versus no training on pain perception, anxiety and behavior in dental setting. Patients were selected from referred patients to Tabriz Dental Faculty, pediatric dentistry department, from 21/4/2015. Ninety patient were randomized using the website www.randomizer.org in two 45 case and control group. Case group will receive coping skill training before dental procedure whereas control group will not receive any training. Inclusion criteria are: 3-6 year old children, have at least one carious primary mandibular molar, needing inferior alveolar nerve block and physical and psychological health. Exclusion criteria are: children who have physical or psychological disorder, history of major medical or dental procedures and history of stress disorders. In both groups pain perception that is primary outcome and anxiety and behavior that are secondary outcomes, will be recorded by blinded person.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511223168N2
Registration date:2016-04-26, 1395/02/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-26, 1395/02/07
Registrant information
Name
Leila Erfanparast
Name of organization / entity
Tabriz University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
erfanparastl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of coping skill training versus no coping training on pain perception, anxiety and behavior in 3-6 years old children during dental treatment as a clinical trial
Public title
Effect of coping skill training on pain perception, anxiety and behavior in dentistry
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 3-6 year old children, attending to Department of Pediatric Dentistry of Tabriz University of Medical Sciences, who has at least one carious primary mandibular molar, needing inferior alveolar nerve block, physical and psychological health according to SDQ (strengths and difficulties questionnaires) test. Exclusion criteria: children under 3 and above 6 year old, children who have physical or psychological disorder, history of hospitalization, history of major medical or dental procedures, history of dental pain and history of stress disorders.
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Using the website: www.randomizer.org
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Science
Street address
Tabriz University of Medical Siceinces, Daneshgah Square, Abresan st.
City
Tabriz
Postal code
Approval date
2015-11-09, 1394/08/18
Ethics committee reference number
TBZMED.REC.1394.848
Health conditions studied
1
Description of health condition studied
dental anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain perception
Timepoint
before and immediately after intervention
Method of measurement
Wong baker faces pain rating scale
Secondary outcomes
1
Description
anxiety
Timepoint
before and immediately after intervention
Method of measurement
venham anxiety rating scale
2
Description
behavior
Timepoint
before and immediately after intervention
Method of measurement
frankle scale
Intervention groups
1
Description
Intervention1: 45 patients in first visit received dental prophylaxis or fluoride therapy using Tell-Show-Do technique. In second visit before dental procedure they will receive coping skill training including deep breathing, silence time, muscle relaxation and releasing anxious thoughts in about 20 minutes. Training these skills will be done by a pediatric dentistry resident. Pain perception, anxiety and behavior in first and second visit will be measured by a resident of pediatric dentistry who is blinded to study.
Category
Behavior
2
Description
Intervention2: 45 patients in first visit received dental prophylaxis or fluoride therapy using Tell-Show-Do technique. In second visit they will receive routine dental procedure without any coping training. Pain perception, anxiety and behavior in first and second visit will be measured by a resident of pediatric dentistry who is blinded to study.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Science Faculty of Dentistry
Full name of responsible person
Elahe Molavi
Street address
Tabriz University of Medical Siceinces, Daneshgah Square, Abresan st.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences Vice chancellor for research
Full name of responsible person
Elahe Molavi
Street address
Tabriz University of Medical Siceinces, Daneshgah Square, Abresan st.
City
Tabriz
Grant name
124202
Grant code / Reference number
10506000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz Dental Faculty
Full name of responsible person
Mohammad Samiei
Position
Research Assistant
Other areas of specialty/work
Street address
Tabriz University of Medical Siceinces, Daneshgah Square, Abresan st.
City
Tabriz
Postal code
Phone
+98 41 3335 5967
Fax
Email
Samiei.moh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Dental Faculty
Full name of responsible person
Leila Erfanprast
Position
pediatric dentist
Other areas of specialty/work
Street address
Tabriz University of Medical Siceinces, Daneshgah Square, Abresan st.
City
Tabriz
Postal code
Phone
+98 41 3335 5967
Fax
Email
erfanparastl@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Dental Faculty
Full name of responsible person
Elahe Molavi
Position
Resident of pediatric dentistry
Other areas of specialty/work
Street address
Tabriz University of Medical Siceinces, Daneshgah Square, Abresan st.
City
Tabriz
Postal code
Phone
+98 41 3335 5967
Fax
Email
elaheh.molavi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)