The primary objective of the study is to find out the music impact on children`s cooperation based on the 2nd and 3rd Frankle during the dentistry operations.
Design
The clinical trial is divided into two groups of 22 people who are treated simultaneously in both groups, one as an intervention group and the other as a control group. (The effect of intervention in each individual is compared with that person himself)
Settings and conduct
place of study: dental clinic of the Medical Sciences of the University of Tehran
Methods: Children are divided into two groups based on the Frankel 2 and 3. In each group, pulpotomy or restoration dentistry is performed at the lower mandibular molar, once with music playback by headphones and once without any music. Before the onset of treatment, the anxiety level is measured by the questionnaire and after completion of the treatment, level of pain is recorded by VAS index, cooperation by Frankl's classification and anxiety is recorded by the Vinkam questionnaire.
Participants/Inclusion and exclusion criteria
Entry requirements: Only Children between 4 - 8 years old are allowed, only the patients with 2nd and 3rd initial Franckle behaviour are allowed, The volunteers must be in need of restorative or pulpotomy traetment of any of the lower jaw primary molar
Non-intervention conditions: The volunteers with systemic, mental, physical disease, The volunteers must be with intense dental pain, The volunteers must be with need for Dental Emergency treatment
Intervention groups
A group of 4 to 8 years old children that once are appointed as the intervention group and then as the control group.
(In each person, the treatment is performed once in a non-musical session (control) and then through a session with music (intervention).
Main outcome variables
sُtudy's effect on cooperation, pain and stress level of the patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190220042779N1
Registration date:2019-06-04, 1398/03/14
Registration timing:registered_while_recruiting
Last update:2019-06-04, 1398/03/14
Update count:0
Registration date
2019-06-04, 1398/03/14
Registrant information
Name
Parisa Ghezloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3420 4968
Email address
parisagh910@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-24, 1398/02/04
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of music impact on children`s cooperation during the dentistry operations : Based on the 2nd and 3rd initial Franckle behavioural
Public title
The study of music impact on children`s cooperation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Only Children between 4 - 8 years old are allowed
Only the patients with 2nd and 3rd initial Franckle behaviour are allowed
The volunteers must be in need of restorative or pulpotomy traetment of any of the lower jaw primary molar.
Exclusion criteria:
The volunteers with systemic, mental, physical disease
The volunteers must be with intense dental pain
The volunteers must be with need for Dental Emergency treatment
Age
From 4 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
More than 1 sample in each individual
Number of samples in each individual:
2
Dental therapy is done on one side of the mandible by playing music, and on the other side without playing any music.
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method in which there is a single sequence of random allocations, has been used. Individual randomization unit is used to randomize random number tables and non-transparent envelopes are used for concealment.
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 dentistry faculty of Tehran medical science university
Street address
6th floor, central department, Keshavarz blv., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-04-23, 1398/02/03
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1398.013
Health conditions studied
1
Description of health condition studied
Restorative treatment or dental pulpotomy on primary molar
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
cooperation level
Timepoint
before and after the treatment process
Method of measurement
franckle measure
Secondary outcomes
1
Description
pain level
Timepoint
after treatment process
Method of measurement
VAS Test
2
Description
anxiety level
Timepoint
before and after the treatment
Method of measurement
Vinkam questionaire
Intervention groups
1
Description
Intervention group: 4-8 year-old children who need dental treatment that undergoes treatment on one side of the lower jaw along with music playback through headphones.
Category
Treatment - Other
2
Description
Control group: 4-8 year-old children who need dental treatment that undergoes treatment on the other side of the lower jaw without music playback.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of dentistry of Tehran university
Full name of responsible person
Donya Alinejad
Street address
Faculty of dentistry of Tehran university, End of north Kargar st., Tehran .Iran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 8801 5950
Email
dentistry@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marzieh Alikhasi Habib Abadi
Street address
Tehran University of Medical Sciences, next to Atomic Energy organization, North Kargar St, Enghelab Sq, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 8801 5950
Email
dentistry@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Donya Alinejhad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry of Tehran university, End of north Kargar st., Tehran .Iran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 8835 1250
Email
donya_alinejhad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Donya Alinejhad
Position
استادیار
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry of Tehran university, End of north Kargar st., Tehran .Iran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 8835 1250
Email
donya_alinejhad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parisa Ghezloo
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, 7th Golbar alley, Biskooran St. Garmsar, Iran
City
Garmsar
Province
Semnan
Postal code
3581677819
Phone
+98 23 3420 4968
Email
parisagh910@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