Preoperative Hip Knee Anxiety Sleep Study

NCT ID: NCT04180527

Last Updated: 2022-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-25
• Study Completion Date: 2022-04-28

Brief Summary

This study is about assessing the impact of reading previous patients' stories related to their hip or knee replacement surgery on patients' preoperative anxiety and sleep. This provision of previous patients' stories is part of an ongoing perioperative QI project in the regional anesthesiology division.

Detailed Description

This will be a pre-post experimental design study. The pre-intervention group of 80 hip or knee replacement surgery patients will receive the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and Pittsburgh Sleep Quality Index (PSQI) in Preop Holding prior to having their block for their surgery. The block resident will give and collect the scale and inventory to patients. Patients are given these surveys as part of a quality improvement initiative, independently of this study. The survey data will be entered into the secure electronic research database. Following this, the post-intervention group of 80 patients will be given copies of previous patients' stories at their last visit to the surgeon's office prior to their surgery. These stories will be administered to all hip and knee surgery patients as part of the new standard of care due to a perioperative QI initiative, independently of this study taking place. These subjects will also receive the APAIS and PSQI for assessment in Preop Holding prior to their block for surgery, as part of the new standard of care. A third party broker will then de-identify the survey data and provide it to the research team for analysis. A two-sided independent t-test will be performed to evaluate the differences in anxiety and sleep scores between the pre- and post-intervention groups.

Conditions

Anxiety; Sleep; Surgery

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Pre-Quality Improvement Initiative

This group of patients have not received previous patients' stories about their hip or knee surgery before undergoing their own hip or knee surgery.

No interventions assigned to this group

Post-Quality Improvement Initiative

This group of patients have received previous patients' stories regarding about their hip or knee surgery before undergoing their own hip or knee surgery.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Planned to undergo a hip or knee replacement surgery at Henry Ford Hospital

Exclusion Criteria

• Diagnoses involving sleep disturbance or psychiatric anxiety

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Gary E. Loyd

Senior Staff Anesthesiologist; Director of Perioperative Surgical Home

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henry Ford Hospital

Detroit, Michigan, United States

Countries

United States

References

Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.

Reference Type: BACKGROUND

PMID: 8623940 (View on PubMed)

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

Reference Type: BACKGROUND

PMID: 2748771 (View on PubMed)

Other Identifiers

12849

Identifier Type: -

Identifier Source: org_study_id