The present study has evaluated the Behavioral Feedback of 6-10 Years pediatric dental patients by Using Virtual Reality Technique during Pulpotomy of Primary molar teeth.20 children, aged 6–10 years, and attending at have taken part in this study. Participants have been studied in one of the two groups randomly under the similar conditions (time and place). Pulpotomies have been done in a mandible by a dentist resident.In first session, all patients of first group experienced virtual reality of Pulpotomy and in second session’s palputomy was without virtual reality technique, but in the second group, treatment sessions have been designed conversely. The amount of pain by Wong-Baker Faces Pain Rating Scale and the child’s behavior by Frankle scale has been evaluated by a dentist surveillant of pulpotomy. In addition, blood pressure and Heart rate criteria of patients have been measured before shot and after the procedure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122420413N1
Registration date:2015-01-31, 1393/11/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-31, 1393/11/11
Registrant information
Name
Negar Mohammadi
Name of organization / entity
Qazvin university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 46330979
Email address
nemohammadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Qazvin University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Virtual Reality Technique on level of Pain and Anxiety during Pulpotomy of Primary molar teeth
Public title
Evaluation of Behavioral Feedback of 6-10 Years pediatric dental pateints by Using Virtual Reality Technique during Pulpotomy of Primary molar teeth
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
6-10 years old children;The Existence of two carious primary molars (D or E) in the maxilla or mandible necessitating Pulpotomy;Not to have Unpleasant Not to have experiences in medical settings;
Not to have Any experience in dental treatment, audiovisual disorders;
Not to have Mental and physical disorders;
Not to have Childhood anxiety related disorders;
Not to have Allergies to Lidocain.
Exclusion criteria:
Toxic children; Treatment time which lasts more than 30 minutes If the patient needs more than one anesthesia; Children who have gag reflex;Children who need pulpectomy during treatment.
Age
From 6 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
faculty of dentistry,Qazvin University of Medical Sciences, Bahonar Blv
City
Qazvin
Postal code
3881969183
Approval date
2014-06-11, 1393/03/21
Ethics committee reference number
8839/20/28
Health conditions studied
1
Description of health condition studied
situational anxiety
ICD-10 code
f93.8
ICD-10 code description
Other childhood emotional disorders
2
Description of health condition studied
pain(tooth pain)
ICD-10 code
k08.8
ICD-10 code description
Other specified disorders of teeth and supporting structures
Primary outcomes
1
Description
systolic and diastolic Blood Pressure and Hart Rate
Timepoint
Before and After pulpotomy
Method of measurement
Pediatric Blood Pressure Monitor with Cuff
2
Description
pain
Timepoint
before and after pulpotomy
Method of measurement
Wong-Baker Fasces Pain Rating and frankle scale
3
Description
child’s behavior
Timepoint
before and after pulpotomy
Method of measurement
Frankle scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: during Local Anesthesia injection and Pulpotomy used an audiovisual eye glasses system (Model: 3D X-Mage VG 601) with internal memory and showed TOM & GERRY cartoon that It is very popular among children.
Category
Behavior
2
Description
The control group: underwent injection with no intervention during Pulpotomy
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty od dentistry, Qazvin University of Medical sciences
Full name of responsible person
Negar mohammadi
Street address
faculty of dentistry,Qazvin University of Medical Sciences, Bahonar Blv
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Qazvin University of Medical Sciences
Full name of responsible person
Dr Asef Zadeh
Street address
faculty of dentistry,Qazvin University of Medical Sciences, Bahonar Blv
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty od dentistry, Qazvin University of Medical sciences
Full name of responsible person
Negar mohammadi
Position
Dentistry Doctor
Other areas of specialty/work
Street address
Goldasht Alley,Golha Quarter, pasdaran Blv
City
Khomein
Postal code
3881969183
Phone
+98 86 4633 0979
Fax
+98 86 4637 3325
Email
mohamadinegar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical sciences (TUMS)
Full name of responsible person
Mahdi Hosseini
Position
Bachelor of Science in Nursing
Other areas of specialty/work
Street address
Unit 5, No 8, Ardehal Alley, North Kargar St
City
Tehran
Postal code
1413653467
Phone
+98 21 8833 4404
Fax
+98 28 1366 9143
Email
mehos2007@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty od dentistry, Qazvin University of Medical sciences
Full name of responsible person
Negar mohammadi
Position
Dentistry Doctor
Other areas of specialty/work
Street address
Goldasht Alley,Golha Quarter, pasdaran Blv
City
Khomein
Postal code
3881969183
Phone
+98 86 4633 0979
Fax
+98 86 4637 3325
Email
mohamadinegar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)