Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Resident Posture Biofeedback-undersøgelse

15. oktober 2026 opdateret af: Wake Forest University Health Sciences

Tjek dig selv, før du ødelægger dig selv: En bærbar biofeedback-enhed til at reducere kirurgisk beboers tid i en ikke-opretstående stilling og arbejdsrelateret muskel- og skeletsmerter

While a majority of surgical ergonomic studies have been evaluating attending surgeons, few have evaluated surgical ergonomics within the surgical resident. Biofeedback devices can be partnered with education and geared towards surgical residents to decrease current and future musculoskeletal disorders, which may in turn lead to longer and more fulfilling careers.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

This study aims to use a commercially-available posture training device for surgical residents that sends biofeedback in the form of a gentle vibration if posture has deviated from the upright (neutral) position for a long period of time. For residents performing minimally-invasive procedures with a laparoscopic approach, our overarching hypothesis is that the time spent in a non-upright position will be less after using the posture biofeedback device compared with before. The study hypothesizes that residents will report fewer complaints related to musculoskeletal pain after wearing the posture training device.

Residents completing general surgery rotations will be recruited and wear a biofeedback device for about four weeks while performing laparoscopic procedures. Posture data from the device and survey data in the form of the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) will be collected and analyzed.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

13

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University Health Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Surgical residents with surgical experience of at least one year (Postgraduate year 2-5)
  • Completing a one-month rotation at the study sites within the general surgery department during the study period

Exclusion Criteria:

  • Clinically diagnosed inflammatory musculoskeletal disorders per self-report
  • History of orthopedic surgery in the last six months per self-report

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Residents

This is a single arm study. All Resident participants will use the posture biofeedback device.

Participants will wear a commercially available posture training device for a two-week tracking period and a two-week training period while performing laparoscopic procedures.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Percentage of Minutes Spent in the Upright Position During Laparoscopic Procedures
Tidsramme: Tracking Phase (Days 1-14) and Training Phase (Days 15-28)

The cumulative percentage of minutes in the upright position during all laparoscopic procedures in the two-week Training Phase minus the cumulative percentage of minutes in the upright position during all laparoscopic procedures in the two-week Tracking Phase.

Tracking Phase (Days 1-14) and Training Phase (Days 15-28)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Self-reported Musculoskeletal Pain Score
Tidsramme: Baseline, Post Tracking Phase (Day 14), and Post Training Phase (Day 28)

Complaints related to musculoskeletal pain assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), a self-reported measure of musculoskeletal discomfort across 20 body regions. The outcome is the sum of body part symptoms. Scores range from 0 to 80 with higher scores indicating symptoms in more body regions and therefore greater musculoskeletal discomfort (a worse outcome).

Baseline, Post Tracking Phase (Day 14), and Post Training Phase (Day 28)
Change in Self-reported Musculoskeletal Neck Pain Using the CMDQ Composite Weighted Score
Tidsramme: Baseline and Post Training Phase (Day 28)

Complaints related to musculoskeletal pain assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), a self-reported measure of musculoskeletal discomfort.

The outcome is a composite weighted score for the body part. Likert responses are assigned a weighted value (Never = 0, 1-2 times/week = 1.5, 3-4 times/week = 3.5, Every day = 5, Several times every day = 10) and then multiplied by the Discomfort (1,2,3) and Interference score (1,2,3). Scores range from 0 to 90 with higher scores indicating greater musculoskeletal discomfort (a worse outcome).

Baseline and Post Training Phase (Day 28)
Change in Self-reported Musculoskeletal Right Shoulder Pain Using the CMDQ Composite Weighted Score
Tidsramme: Baseline and Post Training Phase (Day 28)

Complaints related to musculoskeletal pain assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), a self-reported measure of musculoskeletal discomfort.

The outcome is a composite weighted score for the body part. Likert responses are assigned a weighted value (Never = 0, 1-2 times/week = 1.5, 3-4 times/week = 3.5, Every day = 5, Several times every day = 10) and then multiplied by the Discomfort (1,2,3) and Interference score (1,2,3). Scores range from 0 to 90 with higher scores indicating greater musculoskeletal discomfort (a worse outcome).

Baseline and Post Training Phase (Day 28)
Change in Self-reported Musculoskeletal Left Wrist Pain Using the CMDQ Composite Weighted Score
Tidsramme: Baseline and Post Tracking Phase (Day 14)

Complaints related to musculoskeletal pain assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), a self-reported measure of musculoskeletal discomfort.

The outcome is a composite weighted score for the body part. Likert responses are assigned a weighted value (Never = 0, 1-2 times/week = 1.5, 3-4 times/week = 3.5, Every day = 5, Several times every day = 10) and then multiplied by the Discomfort (1,2,3) and Interference score (1,2,3). Scores range from 0 to 90 with higher scores indicating greater musculoskeletal discomfort (a worse outcome).

Baseline and Post Tracking Phase (Day 14)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: William Sherrill, MD, Wake Forest University Health Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. september 2024

Primær færdiggørelse (Faktiske)

2. november 2025

Studieafslutning (Faktiske)

2. november 2025

Datoer for studieregistrering

Først indsendt

19. august 2024

Først indsendt, der opfyldte QC-kriterier

19. august 2024

Først opslået (Faktiske)

21. august 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. oktober 2026

Sidst verificeret

1. november 2025

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00115419

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner