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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03840356
Other study ID # 18-004244
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 18, 2018
Est. completion date September 30, 2018

Study information

Verified date May 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Effective pain control following surgical procedures is a goal for both the patient as well as the medical staff caring for them. There have been numerous studies evaluating differing treatment pathways, but most studies have relied on the Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) to evaluate outcomes. These scales are subjective score given by the patient with no objective data input, therefore making comparisons subject to possible bias. There are no known studies comparing the pain scores provided by the patient to the surgical team compared to the nursing staff caring for the patient. The aim will be to compare these values to see if patients are consistent in their pain rating.


Description:

The project will be conducted as a prospective study comparing numerical rating scale pain scores reported by the patients to the surgical team and the nursing staff. All orthopedic inpatients will be eligible for the study. Subjects will not be consented for the study prior to data collection in order to prevent bias. At the conclusion of the patient's involvement in the study they will be informed that their data has been collected and will have the opportunity to opt out of the study, at which time the collected data will be destroyed. Postoperatively the surgical team will ask the patient to provide a pain score during morning rounds as part of routine care. The pain score will be recorded by a member of the surgical team. Within 60 minutes of their rounds and prior to any pain inducing events (such as physical therapy or repositioning), the surgical team will ask the nurse caring for the patient to enter the room by his/her self and ask the patient the same routine questions including the pain score. The nurse will record the pain score. No member of the surgical team will enter the room while the nurse is present in order to prevent bias. This process will be repeated once a day up to three days for each patient after the patient's operation.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - All inpatient postoperative orthopedic patients will be eligible for the study. Exclusion Criteria: - If a patient is unwilling to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Postoperative
No intervention is planned in the study. This study is simply evaluating the consistency with which patients report their pain levels to different members of the medical team.

Locations

Country Name City State
United States Mayo Clinic Jacksonville Florida

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain score Pain scores will be compared between those reported by the patient to the nurse and physician to evaluate for consistency. The visual analog scale (VAS) ranges from a minimum score of 0 representing "no pain at all" and a maximum score of 10 which represents "worst pain imaginable". The VAS is represented as a 100 mm horizontal line in increments of 10mm. Subjects indicate their pain level on the scale. 3 days
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