UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056322 |
|---|---|
| Receipt number | R000064349 |
| Scientific Title | Reduction of anxiety in pediatric patients when entering the operation room using Augmented Reality(AR) with tablet devices: A multicenter prospective study |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/11/30 22:37:22 |
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Basic information
Public title
Reduction of anxiety in pediatric patients when entering the operation room using Augmented Reality(AR) with tablet devices: A multicenter prospective study
Acronym
Reduction of anxiety in pediatric patients when entering the operation room using Augmented Reality(AR) with tablet devices: A multicenter prospective study
Scientific Title
Reduction of anxiety in pediatric patients when entering the operation room using Augmented Reality(AR) with tablet devices: A multicenter prospective study
Scientific Title:Acronym
Reduction of anxiety in pediatric patients when entering the operation room using Augmented Reality(AR) with tablet devices: A multicenter prospective study
Region
| Japan |
Condition
Condition
Pediatric patients undergoing scheduled surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify whether AR images using tablet devices can reduce the anxiety of pediatric patients when entering operating room.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the modified Yale preoperative anxiety scale in the AR and Control groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
AR group
The pediatric patient in a wheelchair is guided from the entrance of the surgery department to the operating table using a tablet device with characters placed in various parts of the aisle.
Interventions/Control_2
Control group
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
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The pediatric patients who will undergo scheduled surgery at the affiliated hospitals and who are wheelchair accessible.
Key exclusion criteria
0 to 2 years old and over 11 years old
Patients whose consent was not obtained from their families or themselves
Mental retardation
Severely ill patients (over ASA-PS classification 3)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ayuka |
| Middle name | |
| Last name | Narisawa |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2, iida-nishi, Yamagata City, Yamagata 990-9585, Japan
TEL
0236285400
asakamoto-ygt@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayuka |
| Middle name | |
| Last name | Narisawa |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
990-9585
Address
2-2-2, iida-nishi, Yamagata City, Yamagata 990-9585, Japan
TEL
0236285400
Homepage URL
asakamoto-ygt@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Ayuka Narisawa
Funding Source
Organization
Department of Anesthesiology, Yamagata University Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical review committee of Yamagata University Faculty of Medicine
Address
2-2-2, iida-nishi, Yamagata City, Yamagata 990-9585, Japan
Tel
0236285015
yu-ikekenkyu@jm.kj.yamagata-u.ac.jp
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
| 2024 | Year | 12 | Month | 01 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 30 | Day |
Last modified on
| 2024 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064349
