Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000693820
Ethics application status
Approved
Date submitted
22/07/2019
Date registered
7/06/2021
Date last updated
3/09/2021
Date data sharing statement initially provided
7/06/2021
Date results information initially provided
7/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Do glove balloons decrease dental anxiety in children-A controlled trial
Scientific title
Do glove balloons reduce dental anxiety in children- A single blind parallel randomized controlled trial
Secondary ID [1] 296559 0
"NIL known"
Universal Trial Number (UTN)
U1111-1223-6548
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental anxiety 310344 0
Condition category
Condition code
Mental Health 309074 309074 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intervention is glove balloons
to assess the dental anxiety in children aged(6-12)
intervention given by 2nd year dental students
intervention given individually and face to face
intervention given once only
intervention given during the treatment(in waiting area)
2nd year Dental students(3rd person, not part pf the research) were supposed to give the glove balloon to the children.
Intervention code [1] 312877 0
Behaviour
Comparator / control treatment
The dental anxiety was assessed at two points in control group and this group recieved no intervention
Control group
Active

Outcomes
Primary outcome [1] 308059 0
MCDAS(f) Questionnaire was used to assess the dental anxiety in both groups pre and post intervention.
Timepoint [1] 308059 0
The dental anxiety was assessed immediately after the dental procedure
Secondary outcome [1] 353848 0
nil
Timepoint [1] 353848 0
nil

Eligibility
Key inclusion criteria
children age 6 to 12 years
informed consent by the guardian
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
children who were unwilling
mentally sick
visual impairment

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin tossing/flipping
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SPSS version 17.0 was used and data was entered in 2 parts. Oone comprised of demographic components of participants which include comparison of gender, age and second which was based on the analysis of anticipatory dental anxiety scores.
Maan-Whitney U Test was used to compare dental anxiety scores of both groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/05/2015
Date of last participant enrolment
Anticipated
Actual
12/08/2015
Date of last data collection
Anticipated
Actual
14/08/2015
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 21703 0
Pakistan
State/province [1] 21703 0
islamabad

Funding & Sponsors
Funding source category [1] 301138 0
University
Name [1] 301138 0
Islamic International Dental College
Country [1] 301138 0
Pakistan
Primary sponsor type
University
Name
Islamic International Dental College
Address
Street 41, Sector G-7/4, Islamabad, Pakistan
Country
Pakistan
Secondary sponsor category [1] 300758 0
Hospital
Name [1] 300758 0
Islamic International Dental Hospital
Address [1] 300758 0
Street 41, Sector G-7/4, Islamabad, Pakistan
Country [1] 300758 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301887 0
Dr Humza bin Saeed,Community Department, IIDC,
Ethics committee address [1] 301887 0
Street 41, Sector G-7/4, Islamabad, Pakistan
Ethics committee country [1] 301887 0
Pakistan
Date submitted for ethics approval [1] 301887 0
28/04/2015
Approval date [1] 301887 0
14/05/2015
Ethics approval number [1] 301887 0
IIDC/IRC/2015/005/001

Summary
Brief summary
The purpose of this study was to assess dental anxiety in children and find effectiveness of using glove balloons in reducing dental anxiety among children.
Null hypotheses was stated thus: In children ages 6-12 years, provided with glove balloons visiting dental hospitals(IIDC, PIMS) there is no difference in the mean dental anxiety score measured by MCDAS(f) prior to treatment and the mean dental anxiety score of children not given glove balloons.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88442 0
A/Prof Dr Humza bin Saeed
Address 88442 0
Associate Professor Community Dentistry
Street 41, Sector G-7/4, Islamabad, Pakistan
Country 88442 0
Pakistan
Phone 88442 0
+923335134590
Fax 88442 0
Email 88442 0
[email protected]
Contact person for public queries
Name 88443 0
A/Prof Dr Humza bin Saeed
Address 88443 0
Associate Professor Community Dentistry
Street 41, Sector G-7/4, Islamabad, Pakistan
Country 88443 0
Pakistan
Phone 88443 0
+923335134590
Fax 88443 0
Email 88443 0
[email protected]
Contact person for scientific queries
Name 88444 0
A/Prof Dr Humza bin Saeed
Address 88444 0
Associate Professor Community Dentistry
Street 41, Sector G-7/4, Islamabad, Pakistan
Country 88444 0
Pakistan
Phone 88444 0
+923335134590
Fax 88444 0
Email 88444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Their names, ages, gender, dental anxiety score for both the control and experimental group
When will data be available (start and end dates)?
data will be available from 2015 only as it was done few years ago
Available to whom?
Anyone who wishes to acess it
Available for what types of analyses?
For any type of analyses that you wish to investigate
How or where can data be obtained?
Access subjects to approval by principal investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 376346-(Uploaded-11-03-2020-03-29-20)-Basic results summary.docx
Plain language summaryNo Analysis of data was conducted blind to experiment... [More Details]

Documents added automatically
No additional documents have been identified.