UMIN-CTR Clinical Trial

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
Email	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
Email	ahmedbilalakhtar_18@hotmail.com

Sponsor
Institute	Shaukat Khanum Memorial Cancer Hospital & Research Center.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053643