Tokyo, Sept. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062929) titled 'Effects of Visual, Auditory, and Tactile Stimuli from an Intimate Female Partner on Pain Sensitivity' on Sept. 16.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - No treatment
Primary Sponsor:
Institute - Kawasaki City College of Nursing
Condition:
Condition - None
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to examine the effects of an intimate female partner's presence and involvement, including visual, auditory, and tactile stimuli, on pain sensitivity among healthy Japanese adult men who have been in a relationship with their partner for at least three months.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Partner is present.
Interventions/Control_2 - Partner is not present.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male
Key inclusion criteria - 1) Individuals who have fully understood the nature of the study and have provided both verbal and written informed consent
2) Healthy Japanese adult males aged 18 to 29 years on the day of the study
3) Individuals with no current pain
4) Non smokers
5) Individuals who are obtaining sufficient sleep
6) Individuals who have not engaged in more than 4 hours of exercise on either the day preceding the study or the day before that
7) Individuals with no history or current presence of conditions such as autonomic nervous system disorders, cardiovascular disease, central or peripheral nervous system disorders, or conditions involving sensory or dermatological abnormalities
8) Individuals who have not undergone any form of pharmacological treatment-including oral medication, transdermal patches, or injections such as analgesics or agents affecting the central nervous system, within the three days prior to the start of the study
9) Individuals who, at the time of enrollment, have a partner with whom they have been in a relationship for at least three months
Key exclusion criteria - 1) Individuals with findings that can be judged to be clearly abnormal immediately prior to or during the study
2) Individuals whom the principal investigator determines are unable to maintain a stable mental state or are at risk of becoming unstable
3) Individuals with trauma, skin abnormalities, physical abnormalities, or other conditions at the time of the study
4) Individuals currently taking any analgesics or medications that affect the central nervous system
5) Any other individuals deemed to present difficulties in conducting this study or for whom there is a risk of such difficulties
Target Size - 20
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 06 Month 17 Day
Date of IRB - 2026 Year 08 Month 14 Day
Anticipated trial start date - 2026 Year 09 Month 15 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072052
Disclaimer: Curated by HT Syndication.