UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056278 |
|---|---|
| Receipt number | R000064305 |
| Scientific Title | A pilot study on the effect of prepration using an orientation video on anxiety in school children undergoing surgery |
| Date of disclosure of the study information | 2024/11/27 |
| Last modified on | 2025/04/21 20:16:15 |
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Basic information
Public title
A pilot study on the effect of prepration using an orientation video on anxiety in school children undergoing surgery
Acronym
A pilot study on the effect of prepration using an orientation video on anxiety in school children undergoing surgery
Scientific Title
A pilot study on the effect of prepration using an orientation video on anxiety in school children undergoing surgery
Scientific Title:Acronym
A pilot study on the effect of prepration using an orientation video on anxiety in school children undergoing surgery
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of prepration using an orientation video for school children made at our hospital on anxiety in school children undergoing surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF) in patients at induction of anesthesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Watch the orientation video
Interventions/Control_2
Do not watch the orientation video
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 6-12 years who are scheduled for elective surgery managed by the anesthesiologist
Patients who can obtain informed assent
Patients who can obtain written consent from their guardians
Patients who can communicate in Japanese
Key exclusion criteria
Patients who cannot watch the orientation video
Patients who have had previous surgery
Patients who will not be admitted to the pediatric ward
Patients who are scheduled to be admitted to the intensive care unit after surgery
Patients who wish to receive individualized care by a Child Life Specialist
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akari |
| Middle name | |
| Last name | Yoshida |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
6410012
Address
811-1 Kimiidera Wakayama City
TEL
073-441-0611
akari@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Akari |
| Middle name | |
| Last name | Yoshida |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
6410012
Address
811-1 Kimiidera Wakayama City
TEL
073-441-0611
Homepage URL
akari@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera Wakayama City
Tel
073-447-2300
wa-rinri@wakayama-med.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 | 11 | 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
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
| 2024 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | 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 | 27 | Day |
Last modified on
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064305
