Trial Review

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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
Before operation, children receive midazolam orally to reduce anxiety about operation. Most of the children also have anxiety in receiving this premedication. Our purpose is to reduce this premedication anxiety so we gave playing dough to children to play. mYPAS is used to score the anxiety of children.
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
[email protected]
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
[email protected]
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
[email protected]

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.