Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab

NCT ID: NCT04490369

Last Updated: 2023-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 175 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-07
• Study Completion Date: 2021-04-30

Brief Summary

The purpose of this study is to explore how the timing of procedural sedation medications influences patient comfort and satisfaction with sedation.

Participation in this study will included be randomly assigned to one of two groups (long and short) within standard of care. Each group will observe a time interval between receiving procedural sedation medications and the start of the procedure. A trained observer will evaluate patient experience during the procedure and at the end of the procedure we will ask the participant 3 brief questions about the experience. All other information collected about the experience during the procedure will occur as part of usual care. No further activities will be asked as part of this study. All study activities will occur during a scheduled visit and participation is complete once questions have been answered.

Conditions

Patient Comfort

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1- short interval

Less than or equal to six minutes between receiving sedation and the start of the procedure

No interventions assigned to this group

Group 2- long interval

Greater than or equal to seven minutes between receiving sedation and the start of the procedure

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• English speaking
• Coming to Duke University for Cardiac Catheterization

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradi Granger, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

References

Mall A, Girton TA, Yardley K, Ronn M, Cross E, Smith PJ, Rossman P, McEwen T, Ohman EM, Jones WS, Granger BB. Timing of sedation and patient-reported pain outcomes during cardiac catheterization: Results from the UNTAP-intervention study. Catheter Cardiovasc Interv. 2023 Jan 14. doi: 10.1002/ccd.30535. Online ahead of print.

Reference Type: RESULT

PMID: 36640418 (View on PubMed)

Other Identifiers

Pro00102686

Identifier Type: -

Identifier Source: org_study_id