UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060729 |
|---|---|
| Receipt number | R000069447 |
| Scientific Title | Development of an Attitude Scale for Nurses and Care Workers Regarding the Sexuality of Children and Adults with Severe Physical Disabilities |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/02/22 09:17:36 |
* 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
Development of an Attitude Scale for Nurses and Care Workers Regarding the Sexuality of Children and Adults with Severe Physical Disabilities
Acronym
Development of an Attitude Scale for Nurses and Care Workers Regarding the Sexuality of Children and Adults with Severe Physical Disabilities
Scientific Title
Development of an Attitude Scale for Nurses and Care Workers Regarding the Sexuality of Children and Adults with Severe Physical Disabilities
Scientific Title:Acronym
Development of an Attitude Scale for Nurses and Care Workers Regarding the Sexuality of Children and Adults with Severe Physical Disabilities
Region
| Japan |
Condition
Condition
severe physical disabilities
Classification by specialty
| Neurology | Rehabilitation medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to develop a scale that can effectively measure the attitudes toward sexuality held by nurses and care workers who provide support to individuals with severe physical disabilities aged 12 to 49 years old.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
77 items: 23 items on caregivers' perceptions of sexual development in children and adults with severe physical and mental disabilities (Obara, 2005), and 54 items addressing attitudes toward the sexuality of children and adults with severe physical disabilities. The scale was developed through a review of domestic and international literature and pretesting.
Key secondary outcomes
24 items of the nurses' perceptions of sexual development in children and adults with severe physical and mental disabilities (Ohara, 2005) and 15 items of the Revised Scale of Ethical Behavior for Nurses (Ode, 2019)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nurses and care workers with experience supporting children and adults with severe physical disabilities
Key exclusion criteria
None
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | KUMI |
| Middle name | |
| Last name | KASAI |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Nursing
Zip code
3000-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
TEL
029-840-2175
kasaik@ipu.ac.jp
Public contact
Name of contact person
| 1st name | KUMI |
| Middle name | |
| Last name | KASAI |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Nursing
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
TEL
029-840-2175
Homepage URL
kasaik@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University of Health Scicences, Waseda Institute of Asia-Pacific Studies
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Prefectural University of Health Sciences
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
Tel
029-840-2175
kasaik@ipu.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
| 2026 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | 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
The objective of this study is to develop a scale that measures the attitudes of nurses and care workers toward the sexuality of individuals with severe physical disabilities. The study's participants comprised 45 nurses and 45 care workers with experience supporting children and adults with severe physical disabilities aged 12 years or older and under 50 years. An online questionnaire was administered, covering fundamental attributes, the developed Attitude Scale toward the Sexuality of Children and Adults with Severe Physical Disabilities, general items selected from the Nurses' Perceptions of Sexual Development in Children and Adults with Severe Physical and Mental Disabilities, and the Revised Scale of Ethical Behavior for Nurses.
Management information
Registered date
| 2026 | Year | 02 | Month | 22 | Day |
Last modified on
| 2026 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069447
