UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047019 |
|---|---|
| Receipt number | R000053643 |
| Scientific Title | Impact of incentive-based game therapy and transporting children on toy vehicle to operation theatre on reducing anxiety prior to induction of Anaesthesia. |
| Date of disclosure of the study information | 2022/02/27 |
| Last modified on | 2022/02/27 18:22:15 |
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Basic information
Public title
Impact of incentive-based game therapy and transporting children on toy vehicle to operation theatre on reducing anxiety prior to induction of Anaesthesia.
Acronym
Incentive game for reducing anxiety before Anaesthesia.
Scientific Title
Impact of incentive-based game therapy and transporting children on toy vehicle to operation theatre on reducing anxiety prior to induction of Anaesthesia.
Scientific Title:Acronym
Incentive game for reducing anxiety before Anaesthesia.
Region
| Asia(except Japan) |
Condition
Condition
Completed
Classification by specialty
| Pediatrics | Psychiatry | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the efficacy of incentive-based game therapy and transportation of children to Operation Theatre on battery operated toy vehicle on reducing preoperative anxiety in children undergoing elective Intrathecal chemotherapy under general anaesthesia
Basic objectives2
Others
Basic objectives -Others
The secondary objective was to observe for intraoperative complications, post anesthesia agitation and Post Anesthesia Care Unit (PACU) recovery and discharge time
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The use of incentive-based game therapy and transporting children on toy vehicle car reduces the anxiety scores during induction of anaesthesia and improves the compliance to facemask induction in children undergoing procedure
Key secondary outcomes
Early Discharge from PACU
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
In the intervention group participated in the incentive-based playing activity and were transported to Operation theatre on toy vehicle
Interventions/Control_2
In control group, a pre-decided cartoon was displayed on the TV screen in holding bay waiting area room and children resumed to the normal playing activities provided in holding bay area in usual routine.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 3 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA I and II.
Elective Intra thecal chemo therapy under general anaesthesia.
Key exclusion criteria
Children with history of learning disability and hearing or visual impairment were excluded from the study
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Hammad |
| Middle name | Nabeel |
| Last name | Najeeb |
Organization
Shaukat Khanum Memorial Cancer Hospital & Research Center
Division name
Anaesthesia
Zip code
54770
Address
7-A, Block R-3, Johar Town., Lahore
TEL
03315694418
hammadnajeeb@gmail.com
Public contact
Name of contact person
| 1st name | Ahmed |
| Middle name | Bilal |
| Last name | Akhtar |
Organization
Shaukat Khanum Memorial Cancer Hospital & Research Center
Division name
Anaesthesia
Zip code
54770
Address
7-A, Block R-3, Johar Town., Lahore
TEL
00923325230253
Homepage URL
ahmedbilalakhtar_18@hotmail.com
Sponsor or person
Institute
Shaukat Khanum Memorial Cancer Hospital & Research Center.
Institute
Department
Personal name
Funding Source
Organization
Shaukat Khanum Memorial Cancer Hospital & Research Center.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shaukat Khanum Memorial Cancer Hospital & Research Center.
Address
7-A, Block R-3, Johar Town., Lahore
Tel
+92 42 35905000
crc4@skm.org.pk
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
36
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 27 | Day |
Last modified on
| 2022 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053643
