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Trial registered on ANZCTR


Registration number
ACTRN12613000928718
Ethics application status
Approved
Date submitted
5/08/2013
Date registered
22/08/2013
Date last updated
8/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Does playing dough attenuate children's anxiety about receiving premedication?
Scientific title
Does playing dough attenuate children's anxiety about receiving premedication for genitourinary operations?
Secondary ID [1] 282973 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
to reduce the premedication anxiety of children 3-7 years old who will have a genitourinary operation 289799 0
Condition category
Condition code
Mental Health 290149 290149 0 0
Anxiety
Anaesthesiology 290152 290152 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will use Modified yale preoperative anxiety scale (mYPAS) to score childrens premedication anxiety. We will apply and record it to 100 children having genitourinary operation aged 3-7 years when they enter the preoperative waiting room with their parents. The children will be randomly divided into two groups. After 3 minutes of staying in the room, playing dough will be given to one group of children(group A) (group B will not receive playing dough)and group A will play with it.After 3 minutes of playing, mYPAS will be applied,recorded to both of the groups after the childrens's play. After 5 minutes of the second scoring we will apply oral midazolam 0.5 mg/kg to both groups of children and at that time we will score the 3rd mYPAS and record it for the last time to both groups.
Intervention code [1] 287684 0
Other interventions
Comparator / control treatment
50 children aging between 3-7 years old having genitourinary operation who will not have playing dough while waiting in the preoperative waiting room with their parents.
Control group
Active

Outcomes
Primary outcome [1] 290179 0
Our primary outcome is to reduce the premedication anxiety in 3-7 year old children (who will have elective genitourinary operation) using the modified Yale Preoperative Anxiety Scale (mYPAS).
Timepoint [1] 290179 0
1. The first time when children enter the preoperative waiting room, first mYPAS will be scored.
2. 3 minutes after entering the room, play dough will be given and children will play with it for 3 minutes time then 2nd mYPAS is scored.
3. 5 minutes after the 2nd score, midazolam is applied and 3rd mYPAS is scored
Secondary outcome [1] 304066 0
none
Timepoint [1] 304066 0
none

Eligibility
Key inclusion criteria
children 3-7 years old
having elective genitourinary surgery
Minimum age
3 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with chronic diseases, prematures, growth retardation, visually or hearing impaired and ages lower than 3 or bigger than 7 is excluded

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2013
Actual
Date of last participant enrolment
Anticipated
30/09/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 5267 0
Turkey
State/province [1] 5267 0
Ankara

Funding & Sponsors
Funding source category [1] 287743 0
Self funded/Unfunded
Name [1] 287743 0
Country [1] 287743 0
Primary sponsor type
Individual
Name
Gozde Bumin Aydin
Address
Orun villalari 2764 sok no 7 Cayyolu Ankara 06610
Diskapi Yildirim Beyazit Hospital
Country
Turkey
Secondary sponsor category [1] 286469 0
None
Name [1] 286469 0
none
Address [1] 286469 0
none
Country [1] 286469 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42014 0
Dr Gozde Bumin Aydin
Address 42014 0
Gozde Bumin Aydin
Orun Villari 2764. sok no 7 cayyolu Ankara 06610
Diskapi Yildirim Beyazit Education and Reasearch Hospital
Country 42014 0
Turkey
Phone 42014 0
+90 5326453235
Fax 42014 0
Email 42014 0
drgozdeaydin@yahoo.com
Contact person for public queries
Name 42015 0
Gozde Bumin Aydin
Address 42015 0
Gozde Bumin Aydin
Orun Villari 2764. sok no 7 cayyolu Ankara 06610
Diskapi Yildirim Beyazit Education and Reasearch Hospital
Country 42015 0
Turkey
Phone 42015 0
+905326453235
Fax 42015 0
Email 42015 0
drgozdeaydin@yahoo.com
Contact person for scientific queries
Name 42016 0
Gozde Bumin Aydin
Address 42016 0
Gozde Bumin Aydin
Orun Villari 2764. sok no 7 cayyolu Ankara 06610
Diskapi Yildirim Beyazit Education and Reasearch Hospital
Country 42016 0
Turkey
Phone 42016 0
+905326453235
Fax 42016 0
Email 42016 0
drgozdeaydin@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of play distraction on anxiety before premedication administration: a randomized trial.2017https://dx.doi.org/10.1016/j.jclinane.2016.04.044
N.B. These documents automatically identified may not have been verified by the study sponsor.