Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059390) titled 'Effects of Differences in Body Part Heights on Pressure Distribution in the Prone Position' on Oct. 14.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Kansai University of Social Welfare
Condition:
Condition - Healthy Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate how changes in the height of posture-supporting devices, such as face-down pillows and chest supports, influence body pressure distribution and subjective discomfort in the prone position.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Prone-position support pads for the head, chest, and abdomen (baseline height condition)
Interventions/Control_2 - Prone-position support pads (head elevated only)
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Individuals aged between 18 and 60 years who are in good health and able to understand the Japanese language.
Individuals who can provide written informed consent to participate in the study of their own free will.
Individuals in good physical condition who are capable of maintaining the prone position independently.
Key exclusion criteria - Individuals with physical pain or movement restrictions.
Individuals who experience pain when assuming the positions required for the experiment.
Individuals with a body mass index (BMI) of less than 18.5 or greater than 30.
Individuals with a height of less than 150 cm or greater than 180 cm.
Individuals who are pregnant or may be pregnant.
Individuals with diseases or conditions that may cause sudden changes in health status.
Individuals deemed inappropriate for participation in this experiment by the principal investigator.
Target Size - 20
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 08 Month 04 Day
Date of IRB - 2025 Year 08 Month 04 Day
Anticipated trial start date - 2025 Year 10 Month 14 Day
Last follow-up date - 2025 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067925
Disclaimer: Curated by HT Syndication.