Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062379) titled 'Effects of Visual, Auditory, and Physical Stimuli from an Intimate Male Partner on Pain Sensitivity in Adults' on Sept. 1.
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 - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - partners are present.
Interventions/Control_2 - Partners are absent.
Eligibility:
Age-lower limit - 18
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 Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 17 Day
Anticipated trial start date - 2026 Year 08 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=R000071321
Disclaimer: Curated by HT Syndication.