To determine the effect of acupressure versus control group on anxiety in 8-12 years patients with molar teeth caries
Design
This is a randomized clinical trial, phase II, in which 60 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible children with molar teeth caries referring to the School of Dentistry in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 8 to 12 years,
Class 1 caries penetrates into the dentin of deciduous molars,
Frankel Behavioral Index Grade 2 to 3,
No previous history of dental treatment
Exclusion criteria:
Coagulation disorder,
Severe dental caries,
Pulp tooth involvement,
Mental or cognitive disorder
Intervention groups
Intervention group 1:
Using acupressure bracelet with push-button at point P6 five minutes before repairing tooth decay up to one minute after work
Intervention group 2:
Using conventional bracelet without push-button at point P6 five minutes before repairing tooth decay up to one minute after work
Control group:
Repairing tooth decay without using a bracelet
Main outcome variables
Primary outcome:
The mean score of anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N371
Registration date:2020-11-11, 1399/08/21
Registration timing:prospective
Last update:2020-11-11, 1399/08/21
Update count:0
Registration date
2020-11-11, 1399/08/21
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupressure versus control group on anxiety in 8-12 years patients with molar teeth caries: a randomized clinical trial
Public title
Effect of acupressure versus control group on anxiety in 8-12 years patients with molar teeth caries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 8 to 12 years,
Class 1 caries penetrates into the dentin of deciduous molars,
Frankel Behavioral Index Grade 2 to 3,
No previous history of dental treatment
Exclusion criteria:
Coagulation disorder,
Severe dental caries,
Pulp tooth involvement,
Mental or cognitive disorder
Age
From 8 years old to 12 years old
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
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare three sheets and write "intervention 1" on one sheet and "intervention 2" on another, and "control" on the third one. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-07-12, 1399/04/22
Ethics committee reference number
IR.UMSHA.REC.1399.375
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
The mean score of anxiety
Timepoint
Before the intervention and immediately after that
Method of measurement
Using the Modified Child Dental Anxiety Scale (MCDAS) and Face Image Scale (FIS) and Face, Legs, Activity, Cry, and Consolability (FLACC) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Using acupressure bracelet with push button at point P6 five minutes before repairing tooth decay up to one minute after work
Category
Treatment - Devices
2
Description
Intervention group 2: Using conventional bracelet without push button at point P6 five minutes before repairing tooth decay up to one minute after work
Category
Treatment - Devices
3
Description
Control group: Repairing tooth decay without using bracelet
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry in Hamadan city
Full name of responsible person
Shiva Ansari
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
ansarishiva730@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Shiva Ansari
Position
Dentistry Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
ansarishiva730@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Rezvan Rafatjou
Position
Pediatric Dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
dr.rafatjou@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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
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