UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052561 |
|---|---|
| Receipt number | R000059971 |
| Scientific Title | Research on sexuality education for students with intellectual disabilities |
| Date of disclosure of the study information | 2023/10/23 |
| Last modified on | 2024/10/21 14:47:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research on sexuality education for students with intellectual disabilities
Acronym
Research on sexuality education for students with intellectual disabilities
Scientific Title
Research on sexuality education for students with intellectual disabilities
Scientific Title:Acronym
Research on sexuality education for students with intellectual disabilities
Region
| Japan |
Condition
Condition
NON
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Through the tutoring of sexuality education, we will reveal how students and teachers experience each other and the meanings that arise in the process.
Basic objectives2
Others
Basic objectives -Others
Meaning of Phenomena
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Do the qualitative data obtained provide new insights and understanding?
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Provide individualized instruction in sexuality education using original teaching materials.
Interventions/Control_2
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
| 15 | years-old | < |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible applicants must be enrolled in the upper secondary school of a special needs school for the students with intellectual disabilities, have a mild intellectual disability, and be able to communicate verbally.
Key exclusion criteria
If you have experienced sexual trauma in the past.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | naoko |
| Middle name | |
| Last name | tsuruoka |
Organization
Tokyo Healthcare University
Division name
Wakayama Faculty of Nursing
Zip code
6408269
Address
4-20 Komatsubaradori, Wakayama City, Wakayama Prefecture
TEL
0734355820
n-tsuruoka@thcu.ac.jp
Public contact
Name of contact person
| 1st name | naoko |
| Middle name | |
| Last name | tsuruoka |
Organization
Tokyo Healthcare University
Division name
Wakayama Faculty of Nursing
Zip code
6408269
Address
4-20 Komatsubaradori, Wakayama City, Wakayama Prefecture
TEL
0734355820
Homepage URL
n-tsuruoka@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Funding Source
Organization
None
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
Tokyo Healthcare University Ethics Committee on Human Research
Address
4-1-17 Higashi-Gotanda, Shinagawa-ku, Tokyo
Tel
03-5421-7656
rinri@thcu.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
| 2023 | Year | 10 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 10 | Month | 20 | Day |
Last modified on
| 2024 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059971
