- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06564519
Resident Posture Biofeedback-undersøgelse
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
Betingelser
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
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
North Carolina
-
Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest University Health Sciences
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
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
Efterforskere
- Ledende efterforsker: William Sherrill, MD, Wake Forest University Health Sciences
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00115419
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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