Protocol summary

Study aim
Comparing the effect of animations related and not related to dentistry on the amount of pain and anxiety of 6-8 year old children during mandibular nerve block injection.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, on 48 patients. A simple individual method was used for randomization.
Settings and conduct
For patients referring to the pediatric department of Zahedan Dental School, a profile form will be filled. In the first group, from 15 minutes before the start of the treatment, the related animation will be played, in the second group, from 15 minutes before the start of the treatment, an unrelated animation will be played (in a quiet environment) and in the third group, no animation will be played for the child (control group). ). For the purpose of blinding in this research, the operator, evaluator, and patient will be unaware of the type of intervention. Children will be included in the intervention group by a dental student and will be monitored during the research process.
Participants/Inclusion and exclusion criteria
Children referred to Zahedan pediatric department who are 6 to 8 years old, the patient is not sensitive to anesthetics, the presence of at least one molar requires non-emergency treatment and mandibular occupational therapy, the absence of a history of special diseases and being healthy, having normal intelligence. , Frankel grade 3 and 4, the patient has no history of dental treatment and no previous observation of any of the two animations used in this study will be included in the study, and the non-entry is Frankel grade 1 and 2 and the use of any pain reliever and have sedation 48 hours before injection
Intervention groups
First intervention group: related animation The second intervention group: irrelevant animation Control group: no animation
Main outcome variables
Level of anxiety; intensity of pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220726055560N1
Registration date: 2022-11-11, 1401/08/20
Registration timing: registered_while_recruiting

Last update: 2022-11-11, 1401/08/20
Update count: 0
Registration date
2022-11-11, 1401/08/20
Registrant information
Name
Abdolkarim Faraji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 937 056 8627
Email address
saeedfarajiii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Watching Dental and Non-Dental-Related Animations on Pain and Anxiety in 6-8 Year Old Children During Mandibular Nerve Block Injection
Public title
Effect of watching animation in children's dentistry
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 6 to 8 years The presence of at least one asymptomatic molar requires non-emergency treatment and occupational therapy under mandibular nerve block anesthesia. Absence of history of specific diseases and being healthy at the time of entering the study Having natural intelligence (based on the child's behavior and speech) The patient should be Frankel grade 3 or 4 in terms of cooperation The patient does not have a history of dental treatment No previous viewing of any of the two animations used in this study
Exclusion criteria:
The patient should be Frankel grade 1 and 2 in terms of cooperation During the study, the presence of a medical problem or the occurrence of certain diseases is diagnosed Taking any pain reliever and sedative 48 hours before the injection Dissatisfaction of parents to participate in this study Allergy to anesthesia
Age
From 6 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
People were divided into three blocks of 8. Each block corresponded to one of three groups of related animation, unrelated animation, and control, into which subjects were assigned by selecting sealed envelopes. Randomization method: limited (block). This method is used to create groups with equal numbers Randomization Unit: Individual Layers of randomization in case of using layered randomization: none Randomization tool: sealed envelope Creating a random sequence using Random allocation software Opaque sealed envelopes with random sequence are used for concealment. In this method, a number of letter envelopes are prepared with aluminum foil (for the lack of clarity of the contents of the envelopes), and each of the random sequences created is recorded on a card and the cards are placed inside the letter envelopes in order. In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box in order. Then the participants take one of the letter envelopes and open them, and the assigned group of that participant is revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before entering the therapy department, children enter the room to watch the animation and then enter the therapy department with or without watching the animation. Therefore, the outcome assessor and the therapist are not aware of the conditions and do not have the right to question the child in this regard. Also, due to the coding of questionnaires and not determining the type of intervention, the analyst does not know the ratio of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr. Hasabi Square - Medical Sciences Pardis
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2022-09-04, 1401/06/13
Ethics committee reference number
IR.ZAUMS.REC.1401.200

Health conditions studied

1

Description of health condition studied
Pulp disease
ICD-10 code
K04.0
ICD-10 code description
Pulpitis

Primary outcomes

1

Description
Anxiety severity based on Venham test
Timepoint
Only when injecting local anesthesia
Method of measurement
Using Venham's visual test

2

Description
Pain intensity based on Sound-Eye-Motor Scale (SEM)
Timepoint
Only when injecting local anesthesia
Method of measurement
Using the SEM scale

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: once broadcast animation related to dentistry (practice in dentistry) for 15 minutes before starting the treatment in a quiet environment.
Category
Behavior

2

Description
The second intervention group: once broadcast an animation not related to dentistry (mustrabin-hot sauce challenge) for 15 minutes before starting the treatment in a quiet environment.
Category
Behavior

3

Description
Control group: patient entering the treatment room without playing the animation
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Pediatrics, Zahedan Faculty of Dentistry
Full name of responsible person
Masoume Danesh
Street address
Dr. Hasabi Square - Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 1111 1111
Email
saeedfarajiii@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nur Mohammad Bakhshani
Street address
Dr. Hasabi Square - Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2117
Email
saeedfarajiii@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice President of Research, Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Masoume Danesh
Position
Faculty member
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dr. Hasabi Square - Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 1234 5678
Email
Nbh2020@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Masoume Danesh
Position
Faculty member
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dr. Hasabi Square - Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 1234 5678
Email
Nbh2020@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Masoume Danesh
Position
Faculty member
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dr. Hasabi Square - Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 1234 5678
Email
Nbh2020@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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