The purpose of this study is the comparison effectiveness of audio distraction methods on pain and anxiety of 4-8 years old children during dental treatment
Design
Clinical trial with two groups of intervention with control group, with cross sectional groups, single blind, randomized
Settings and conduct
This study will be conducted at the private clinic of Hamid Sarlak, a pediatric dentistry specialist in Arak. For each patient, according to the groups assigned, pulpotomy and SSC treatment will be done in the presence of one of the audio distraction in one side and in the next treatment session, the treatment will be performed in the presence of a other method on the opposite side. In the treatment sessions at a specific time, pain and anxiety levels are measured with heart rate, SEM, and FPR.
Participants/Inclusion and exclusion criteria
60 children 4 to 8 years old, at children's dentistry office in Arak city in 99-98
candidates for double sided pulpotomy and stainless steel crown (SSC) in the first or second primary maxillary molars of the same type
They are healthy genetically, systemic and learning ability
They have no history of dental treatment and hospitalization
In Frankel cooperation scale should be in positive or definitely positive position
Existence of severe pain or obvious need for treatment on a side earlier of opposite side that excludes the study from random state, prevent entry.
Intervention groups
Group 1: First session Audio story Second session Music
Group 2: First session Music Second session Audio Story
Main outcome variables
Pain; Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190702044077N1
Registration date:2019-09-29, 1398/07/07
Registration timing:prospective
Last update:2019-09-29, 1398/07/07
Update count:0
Registration date
2019-09-29, 1398/07/07
Registrant information
Name
Maedeh Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3372 1472
Email address
dr_maedehsadeghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of effectivness of Adiou Distraction Methods on Pain and Anxiety of 4-8 years old Paediatric Patient During Dental Treatment
Public title
Effect of Adiou Distraction Methods on Pain and Anxiety During Dental Treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients should be candidates for double sided pulpotomy and stainless steel crown (SSC) in the first or second primary maxillary molars of the same type
They are genetically, systemic and able to learn healthy
They have no history of dental treatment and hospitalization
In Frankel cooperation scale should be in positive or definietly positive position
Exclusion criteria:
Existence of severe pain or obvious need for treatment on one side earlier of opposite side that excludes the study from a random state
Lack of cooperation for attending medical sessions
Age
From 4 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
Child with first or second primary molars simillary on both sides of the maxilla, that require pulpotomy and stainless steel crown
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple
Randomization Unit: Individual
Randomization tool: software will be used to place persons in two groups based on the preference and delay of the method and in the third session for selection the maxillary quadrant, 60 very similar envelopes, half of which are zero and half of which are one, are used. In the first treatment session, move the envelopes, then select one envelope for each child, if the number is zero,.reatment on the right and if the number is one treatment on the left will be done.
The concealment is carried out by envelopes of a black and same shape that are not clearly identified.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is a single blind study. In this study, the assistant dentist who records the indices is unaware of how individuals are assigned to the groups and the type of intervention performed at each session to treat individuals. According to the present study, since the intervention of all participants during the treatment is to listen to the audio story or music, it is not possible to keep the participants blind and the participants will notice What kind of media do they listen to either way.The present study is a preventive study and participants' blindness did not have a clear effect on the results.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak university of Medical Sciences
Street address
Academic complex of the Great Prophet, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.ARAKMU.REC.1398.120
Health conditions studied
1
Description of health condition studied
The amount of pain and anxiety of a child during dental treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pulse rate
Timepoint
Heart rate at first and second sessions once and for all treatment sessions (third and fourth sessions) three times is measured and recorded by the dentist's assistant.1. One minute after the start of the method of distraction 2. During injection Local anesthetic 3. During pulp exposure
Method of measurement
To determine the heart rate, the digital electronic device OXY300 (Microlife AG, Widnau, Switzerland) will be used by placing the probe on the child's left hand finger.
2
Description
Face pain rate
Timepoint
After starting the distraction method
Method of measurement
The subjective evaluation of pain is performed by the FPR scale after the starting distraction method wich is recorded by the child using it's scoring image, and determined score by the next session in the presence of another distraction method are compared.
3
Description
Evaluation of pain by eye, movement and sound (SEM)
Timepoint
After starting the distraction method
Method of measurement
The Objective scale used to measure pain is a SEM scale that evaluates the status of the child's sound, eyes, and movements according to the score table. The score for this scale is recorded by the dentist's assistant after the start of the specific method of distraction. The score is compared with the score of the next session in the presence of the another distraction method.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Playing the audio story, in this study three audio stories for a total of 30 minutes with the voice of Ms. Pegah Razavi,from a MP3 player model of the RM-1101 by JBL wired headset during treatment for the child, is used.
Category
Prevention
2
Description
Intervention group: Music playing, In this study, both kind of relaxed and happy chidlish music will be used as a 30-minute package. which is distributed by a MP3 player model of the RM-1101 by JBL wired headset during treatment for the child.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Hamid Sarlak's office Pediatric Dentistry
Full name of responsible person
Hamid Sarlak
Street address
Fifth Floor, Mir Ahmad Building, Azod Corner, Shahid Beheshti Street
City
Arak
Province
Markazi
Postal code
3813634159
Phone
+98 86 3222 3794
Email
Dr.hamidsarlak@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Mohammad Arjmandzadegan
Street address
Academic Complex of the Great Prophet, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3645
Email
mmatinam81@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hamid Sarlak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Fifth Floor, Mir Ahmad Building, Azod Corner, Shahid Beheshti Street
City
Arak
Province
Markazi
Postal code
3813634159
Phone
+98 86 3222 3794
Email
Dr.hamidsarlak@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Maedeh Sadeghi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Narges Hostel, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009833721472
Email
dr_maedehsadeghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Maedeh Sadeghi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Narges Hostel, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 21 3372 1472
Email
dr_maedehsadeghi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data are publishable
When the data will become available and for how long
One year after publishing results
To whom data/document is available
All researcher in university and research centers
Under which criteria data/document could be used
There are no conditions
From where data/document is obtainable
Dr Hamid Sarlak
What processes are involved for a request to access data/document
Request a person by email Investigating university affiliation of the requesting person send information via email the maximum time of this process is one month.