Tokyo, July 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058169) titled 'A study on how bed angle affects perceived discomfort and physical responses' on July 28.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Non-randomized
Blinding - Single blind -participants are blinded
Control - No treatment
Primary Sponsor:
Institute - Osaka Metropolitan University
Condition:
Condition - Not Applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to identify the head-of-bed elevation angle that causes the least discomfort in adults maintaining the same body position, using subjective evaluation and physiological response as indicators.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Experiment 1 (Head-of-Bed Elevation at 30 degrees)
Interventions/Control_2 - Experiment 2 (Head-of-Bed Elevation at 45 degrees)
Eligibility:
Age-lower limit - 45
years-old
=
Gender - Male and Female
Key inclusion criteria - 1.Participants will be men and women aged between 45 and under 65 years.
2.Participants must be able to take part in all three experiments: Experiment 1 (head-of-bed elevation at 30 degrees), Experiment 2 (head-of-bed elevation at 45 degrees), and Experiment 3 (head-of-bed elevation at 60 degrees).
Key exclusion criteria - 1.Individuals with diseases that may cause dizziness or malaise due to elevation or lowering of the head or foot sections of the bed.
2.Individuals without current or past history of lumbar spine disorders.
3.Individuals currently undergoing treatment for any disease.
4.Individuals without subjective symptoms of paralysis or pain, for the purpose of pain assessment.
5.Individuals who have taken analgesics within the past 24 hours.
6.Women who are menstruating.
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 13 Day
Anticipated trial start date - 2025 Year 07 Month 28 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066492
Disclaimer: Curated by HT Syndication.