Comparison the effect of hypnosis,nitrous oxide and conventional behavior guidance on anxiety level of school-age children during local anesthesia injection and dental extraction
Determination the effect of hypnosis,nitrous oxide and conventional behavior guidance on anxiety level of school-age children during local anesthesia injection and dental extraction
Design
Three arm parallel group randomized trial
Settings and conduct
Among children referred to pediatric dentistry department of dental faculty and need tooth extraction ,75 children will be recruited in the study.Children who have mild to moderate anxiety randomly will be assigned into three groups:1- hypnotism 2-nitrous oxide 3- conventional behavior guidance.In treatment phase for all children,10 minutes after local anesthesia administration,the tooth will be extracted.Child anxiety will be recorded before and during the local anesthesia and during the dental extraction .For this reason, child's vital signs such as oxygen saturation and heart rate will be recorded by pulseoximeter. During all treatment procedures a camera will record the child behavior and his anxiety level will be scored by examiner.At the end of the treatment the child anxiety level will also be evaluated by Venham picture test.Finally the children anxiety level will be compared between groups.
Participants/Inclusion and exclusion criteria
7-11 year-old school-aged children
Having mild to moderate anxiety
Having no chronic systemic diseases
Having no mental retardation and autism
Having no history of dental treatment with hypnosis or nitrous oxide
Having primary molar candidate for extraction
Intervention groups
Hypnotism group
Nitrous oxide group
Conventional behavior guidance group
Main outcome variables
Anxiety level ;Heart rate ;Oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161007030193N3
Registration date:2019-01-28, 1397/11/08
Registration timing:registered_while_recruiting
Last update:2019-01-28, 1397/11/08
Update count:0
Registration date
2019-01-28, 1397/11/08
Registrant information
Name
Iman Parisay
Name of organization / entity
Mashhad University of Medical Sciences-Mashhad Dental Faculty
Country
Iran (Islamic Republic of)
Phone
+98 51 3608 6977
Email address
parisayi@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-05-05, 1398/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of hypnosis,nitrous oxide and conventional behavior guidance on anxiety level of school-age children during local anesthesia injection and dental extraction
Public title
Comparison the effect of hypnosis,nitrous oxide and conventional behavior guidance on anxiety level of school-age children during local anesthesia injection and dental extraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
7-11 year-old school-aged children
Having mild to moderate anxiety
Having no chronic systemic diseases
Having no mental retardation and autism
Having no history of dental treatment with hypnosis or nitrous oxide
Having primary molar candidate for extraction
Exclusion criteria:
Uncooperative patient
Not hypnosis
Age
From 7 years old to 11 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
In this study the participants divided into three groups by block randomization method by use of web program "randomizer.org"
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 Mashhad University of Medical Sciences
Street address
Mashhad Dental Faculty, Vakil Abbad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
91735
Approval date
2018-06-13, 1397/03/23
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.026
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F93.1
ICD-10 code description
Phobic anxiety disorder of childhood
Primary outcomes
1
Description
Anxiety level
Timepoint
before local anesthesia injection-during local anesthesia injection- during dental extraction
Method of measurement
Venham Clinical Anxiety and Cooperation Scale
Secondary outcomes
1
Description
Heart rate
Timepoint
Before local anesthesia injection, during local anesthesia injection, during dental extraction
Method of measurement
Pulsoximetre
2
Description
Oxygen saturation
Timepoint
Before local anesthesia injection, during local anesthesia injection, during dental extraction
Method of measurement
Pulsoximetre
Intervention groups
1
Description
Intervention group 1: participants who were hypnotized during local anesthesia injection and dental extraction.The hypnosis intervention included a standard 3-minute progressive muscle relaxation induction followed by a 5-minute deepening procedure aimed at increasing the patients’ focus, absorption, and concentration. In the intervention phase the hypnotic suggestions were aimed at modifying their perception of pain.
Category
Treatment - Other
2
Description
Intervention group 2: participants who were sedated by nitrous oxide during local anesthesia injection and dental extraction. At first introduction of 100 percent oxygen for two minutes followed by titration of nitrous oxide in 10 percent intervals up to 40% concentration of nitous oxide to achieve ideal sedation.After local anesthesia injection and dental extraction. the nitrous oxide flow is terminated, 100 percent oxygen should be delivered for five minutes
Category
Treatment - Drugs
3
Description
Control group: participants who were managed during local anesthesia injection and dental extraction by conventional behavior guidance such as Tell Show Do technique and roll modeling and voice control method
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dental Faculty
Full name of responsible person
Dr.Iman Parisay
Street address
Mashhad Dental Faculty-Vakil Abbad BLVD
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
parisayi@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Research Vice chancellor of Mashhad University of Medical Sciences -Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Iman Parisay
Position
Associate Professor of pediatric dentistry department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental Faculty-Vakil Abbad BLVD
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
Email
parisayi@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Iman Parisay
Position
Associate Professor of pediatric dentistry department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental Faculty-Vakil Abbad BLVD
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
Email
parisayi@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Iman Parisay
Position
Associate Professor of pediatric dentistry department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental Faculty-Vakil Abbad BLVD
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
Email
parisayi@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data are available among corresponding author
When the data will become available and for how long
After publication of the article
To whom data/document is available
Every one who needs for scientific aims such as researchers who work on systematic review
projects
Under which criteria data/document could be used
For research aims by formal request
From where data/document is obtainable
Contact with corresponding author by e-mail address
What processes are involved for a request to access data/document
After discussion the authors decide to accept or reject the request