To evaluate the efficacy of audiovisual aid in reducing the level of dental anxiety in patients undergoing tooth extraction
Design
A randomized trial will be conducted where 162 patients will be randomly divided into two equal groups of 81 each, with help of random sequence generated using online tool.
Settings and conduct
University dental hospital, The university of Lahore. The person collecting the data will be blinded to the intervention given to the individuals.
Participants/Inclusion and exclusion criteria
Inclusion:
Simple extraction procedure
American society of anesthesiologist physical status class 1 & 2
Patient able to comprehend and follow the instructions
Exclusion:
Surgical extractions
More than two extractions to be performed
Grade 2 or 3 mobility of the tooth
Patients who do not understand Urdu
Patients who did not give consent
Intervention groups
1. Verbal instructions
2. Audiovisual aid
Main outcome variables
Dental anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221208056747N1
Registration date:2023-01-31, 1401/11/11
Registration timing:retrospective
Last update:2023-01-31, 1401/11/11
Update count:0
Registration date
2023-01-31, 1401/11/11
Registrant information
Name
Palwasha Babar
Name of organization / entity
The university of Lahore
Country
Pakistan
Phone
+92 334 8740767
Email address
palwasha.babar@ucd.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-20, 1401/09/29
Expected recruitment end date
2023-01-30, 1401/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of audiovisual aid in reduction of dental anxiety during tooth extraction: A randomized clinical trial
Public title
The role of audiovisual aid in reduction of dental anxiety
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Simple extraction procedure
American society of anesthesiologist physical status class 1 & 2
Exclusion criteria:
Surgical extractions
More than two extractions to be performed
Grade 2 or 3 mobility of the tooth
Patients who do not understand Urdu
Patients who did not give consent
Age
From 17 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
162
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization technique will be followed and the 162 participants of the study will be randomly divided into two equal groups according to lottery method. 162 slips will be made, 81 for audiovisual aid and 81 for verbal instruction. A slip will be picked at random from the box to allocate the patient a group.
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
Institutional Review Board, The University of Lahore
Street address
1-km Raiwind road
City
Lahore
Postal code
54000
Approval date
2022-06-10, 1401/03/20
Ethics committee reference number
UCD/ERCA/12468
Health conditions studied
1
Description of health condition studied
Dental anxiety
ICD-10 code
F40.2
ICD-10 code description
Specific (isolated) phobias
Primary outcomes
1
Description
Dental anxiety
Timepoint
Before intervention and after intervention with tooth extraction
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Participants in this group will be verbally instructed about the steps involved in tooth extraction before the start of the procedure. Dental anxiety will be measured before and after the tooth extraction.
Category
Behavior
2
Description
Intervention group: Participants in this group will be informed using visual aid about the steps involved in tooth extraction before the start of the procedure . Dental anxiety will be measured before and after the tooth extraction.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
University dental hospital, The university of Lahore
Full name of responsible person
Ijaz ur Rehman
Street address
1-km Raiwind road
City
Lahore
Postal code
54000
Phone
+92 334 4342501
Email
ijaz.rahmannn@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr. Saqib Naeem Siddique
Street address
1-km Raiwind road
City
Lahore
Postal code
54000
Phone
+92 331 7274267
Email
saqibns@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Lahore
Proportion provided by this source
100
Public or private sector
Private
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
The university of Lahore
Full name of responsible person
Ijaz ur Rehman
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
1-km Raiwind road
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 334 4342501
Email
ijaz.rahmannn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The university of Lahore
Full name of responsible person
Palwasha Babar
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
1-km Raiwind road
City
lahore
Province
punjab
Postal code
54000
Phone
+92 334 8740767
Email
palwasha.babar@ucd.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Uswa Qaiser
Position
Demonstrator
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
1-km Raiwind road
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 333 5374544
Email
uswaqaiser7@gmail.com
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
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
The data will be shared as published research article as "The role of audiovisual aid in reduction of dental anxiety during tooth extraction: A randomized clinical trial".
The IPD measuring the primary outcome i.e. dental anxiety before and after the tooth extraction in both control and intervention group will be ahred.
When the data will become available and for how long
The data will be available once the study is published. The article will be available online for 5 years or as per the journal policy.
To whom data/document is available
To fellow academic researchers and dentists.
Under which criteria data/document could be used
Data will be available for future research after approval by the principal investigator.
From where data/document is obtainable
Published journal
What processes are involved for a request to access data/document
It will be as per the journal policy in which article is published.