- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06564519
Resident Posture Biofeedback-studie
Sjekk deg selv før du ødelegger deg selv: En bærbar biofeedback-enhet for å redusere kirurgisk pasients tid i en ikke-oppreist stilling og arbeidsrelatert muskel- og skjelettsmerter
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
North Carolina
-
Winston-Salem, North Carolina, Forente stater, 27157
- Wake Forest University Health Sciences
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: William Sherrill, MD, Wake Forest University Health Sciences
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00115419
Plan for individuelle deltakerdata (IPD)
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