UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062379 |
|---|---|
| Receipt number | R000071321 |
| Scientific Title | Effects of Visual, Auditory, and Physical Stimuli from an Intimate Male Partner on Pain Sensitivity in Adults |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/07/29 10:46:54 |
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Basic information
Public title
Effects of Visual, Auditory, and Physical Stimuli from an Intimate Male Partner on Pain Sensitivity in Adults
Acronym
Effects of Visual, Auditory, and Physical Stimuli from an Intimate Male Partner on Pain Sensitivity in Adults
Scientific Title
Effects of Visual, Auditory, and Physical Stimuli from an Intimate Male Partner on Pain Sensitivity in Adults
Scientific Title:Acronym
Effects of Visual, Auditory, and Physical Stimuli from an Intimate Male Partner on Pain Sensitivity in Adults
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of visual and auditory stimuli, as well as physical contact, from an intimate male partner on pain sensitivity in young female adults.
Basic objectives2
Others
Basic objectives -Others
This study examines within-participant differences in pain sensitivity depending on whether their partners are present or absent.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain intensity with the visual analogue scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
partners are present.
Interventions/Control_2
Partners are absent.
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Individuals who have fully understood the study procedures and provided both oral and written informed consent.
2. Healthy Japanese adult women aged 18 to 29 years (inclusive) at the time of participation.
3. Individuals with no current pain (acute or chronic) at the time of the study.
4. Non-smokers.
5. Individuals who have obtained sufficient sleep prior to participation.
6. Individuals who have not engaged in exercise exceeding 4 hours per day, both on the day before and on the day of the experiment.
7. Individuals with no history or current diagnosis of autonomic nervous system disorders, cardiovascular disorders, central or peripheral nervous system disorders, or conditions involving sensory or dermatological abnormalities.
8. Individuals who have not undergone any form of pharmacological treatment (e.g., oral, transdermal, or injectable administration), including analgesics or centrally acting drugs, within the 3 days prior to the start of the study.
9. Individuals who are within 1 week following the end of menstruation.
10. Individuals who have been in a romantic relationship with their partner for 3 months or longer at the time of application.
Key exclusion criteria
1. Individuals in whom clearly abnormal findings are observed immediately before or during the course of the study.
2. Individuals judged by the principal investigator to be unable to maintain psychological stability, or to be at risk of such instability.
3. Individuals with trauma, skin abnormalities, or other physical abnormalities at the time of the study.
4. Individuals who are taking any analgesics or drugs acting on the central nervous system.
5. Individuals otherwise judged by the investigator to be unable to complete the study, or to be at risk of being unable to do so.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Kakeda |
Organization
Kawasaki City College of Nursing
Division name
Faculty of Nursing
Zip code
212-0054
Address
4-30-1 Ogura, Saiwai-ward, Kawasaki, Kanagawa, Japan
TEL
+81-44-587-3520
kakeda-t@kawasaki-cn.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Kakeda |
Organization
Kawasaki City College of Nursing
Division name
Faculty of Nursing
Zip code
212-0054
Address
4-30-1 Ogura, Saiwai-ward, Kawasaki, Kanagawa, Japan
TEL
+81-44-587-3520
Homepage URL
kakeda-t@kawasaki-cn.ac.jp
Sponsor or person
Institute
Kawasaki City College of Nursing
Institute
Department
Personal name
Nozomi Matsumura
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee in Kawasaki City College of Nursing
Address
4-30-1 Ogura, Saiwai-ward, Kawasaki, Kanagawa, Japan
Tel
+81-44-587-3500
ethics@kawasaki-cn.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 | 09 | 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 | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 15 | 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
| 2026 | Year | 07 | Month | 29 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071321
