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A study to assess the impact of wearing archelisFX in reducing surgeons load during surgery

A Clinical Study on Reducing Physical and Psychological Load of Surgeons During Surgery Using archelisFX - RELAX Study(REducing Load with ArchlisfX)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042250119
Enrollment
64
Registered
2025-10-27
Start date
2025-10-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical and psychological workload of surgeons standing in the operating room

Interventions

Participants will be allocated to either the archelisFX-wearing group or the non-wearing group based on the research objective.
archelisFX

Sponsors

Morita Yoshifumi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Surgeons affiliated with Hamamatsu University School of Medicine 2.Individuals whose physique fits the archelisFX (M size): height between 160 cm and 185 cm, and body weight less than 90 kg 3.Individuals who have provided written informed consent to participate in this study

Exclusion criteria

Exclusion criteria: 1.Individuals whose body physique does not meet the fitting criteria for archelisFX (M size) 2.Individuals with pre-existing medical conditions that cause pain or functional disorders in the lower back or legs 3.Individuals who have been instructed by their department head or attending physicians to restrict working hours 4.Junior residents (postgraduate year 1-2) 5.Surgeons engaged in emergency operations

Design outcomes

Primary

MeasureTime frame
Borg scale scores obtained from participants under the archelisFX-wearing and non-wearing conditions

Secondary

MeasureTime frame
Heart rate variability, including average heart rate, maximum heart rate, and heart rate variability range, measured by Fitbit. Time Frame : During each surgical procedure Degree of physical fatigue and pain perceived during surgery, evaluated using the Visual Analogue Scale(VAS). Time Frame : Immediately after surgery Subjective evaluation of device use, assessed using a five-point Likert scale for comfort and restrictions associated with wearing the assist suit, with additional free-text comments on perceived advantages or areas for improvement. Time Frame : Immediately after surgery

Contacts

Public ContactDaiki Nishiwaki

Hamamatsu University School of Medicine

shijikitabaseball1612@gmail.com+81-53-435-2279

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026