To determine the effect of Audio Visual eyeglasses system on severity of pain and anxiety during dental injection, a double blinded crossover clinical trial was done over 40 healthy children; aged between 6 to 8 years old. Children having the inclusion criteria were coded and by using website www.randomizer.org randomly allocated into two groups (each group consisted of 20 children).The study was done during 3 continuance sessions. At the first visit prophylaxis & fluoride therapy was done for both two groups. Next session the first group used an audiovisual eyeglasses system during dental treatment & the second group underwent injection with no intervention .During last session injection was done with no intervention for first group but by using Audiovisual eyeglasses for second group. All the injections were done by a resident of paediatric dentistry. Then at the end of each session subjects' pain severity was assessed, with pictorial VAS scale (visual Analogue Scale) & situational anxiety measured by Modified Child Dental Anxiety Scale (MCDAS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103126036N1
Registration date:2011-04-28, 1390/02/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-28, 1390/02/08
Registrant information
Name
Armaghan Naghili
Name of organization / entity
Tabriz dental faculty
Country
Iran (Islamic Republic of)
Phone
00984115446695-00984115447283
Email address
naghilia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-04-17, 1389/01/28
Expected recruitment end date
2010-06-21, 1389/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The influence of virtual reality eye glasses on severity of pain and anxiety during inferior alveolar nerve block in 6-8 age children
Public title
The influence of virtual reality eye glasses on severity of pain and anxiety during inferior alveolar nerve block in 6-8 age children
Purpose
Supportive
Inclusion/Exclusion criteria
The selected cases should have no systemic diseases such as bleeding problems, and mental disabilities. inclusion criteria: Existence of carious primary molars necessitating administration inferior alveolar nerve block anaesthesia, have no Previous experience of intra oral injection, have no allergy to Lidocaein, have no History of pain secondary to pulpitis favouring a biased context due to special pain status such as hyperalgesia or allodynia, have no History of unpleasant experiences in medical settings, have no mental, psychological and behaviour problems, absence of childhood anxiety related disorders, SCARED questionnaire score > 25
Age
From 6 years old to 8 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences,Tabriz Dental Faculty
Street address
Tabriz,Golgasht st.
City
Tabriz
Postal code
Approval date
2010-11-21, 1389/08/30
Ethics committee reference number
8951
Health conditions studied
1
Description of health condition studied
situational anxiety
ICD-10 code
f93.8
ICD-10 code description
Emotional disorders with onset specific to childhood ,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 structur,Toothache NOS es
Primary outcomes
1
Description
pain during dental injection
Timepoint
Immediately after injection
Method of measurement
pictorial VAS (Visual Analouge Scale)
Secondary outcomes
1
Description
situational anxiety during dental injection
Timepoint
immediatly after injection
Method of measurement
MCDAS (Modified Children Dental Anxiety Scale)
Intervention groups
1
Description
The intervention group: used an audiovisual eyeglasses system during dental treatment (the eyeglasses system showed TOM &GERRY cartoon for children)
Category
Behavior
2
Description
The control group: underwent injection with no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Dental Faculty
Full name of responsible person
Dr. Naser Asl Aminabadi
Street address
Gogsht st.,Tabriz Dental Faculty
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostad Rahimi
Street address
Vice chancellor for Research, Tabriz University of Medical Sciences, Daneshgah Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Department Of Pediatric Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Dr Naser Asl Aminabadi
Position
DDS, MSc, Associate professor
Other areas of specialty/work
Street address
Tabriz Dental Faculty, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41133559657
Fax
Email
aslaminabadi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Naser Asl Aminabadi
Position
DDS, MSc, Associate professor
Other areas of specialty/work
Street address
Tabriz Dental Faculty, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41133559657
Fax
Email
aslaminabadi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences,Dental Faculty