Preoperative Hip Knee Anxiety Sleep Study

Completed

• Conditions: Sleep; Surgery; Anxiety

• Registration Number: NCT04180527
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study Start: 2019-02-25
• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-27
• Primary Completion: 2022-04-28
• Study Completion: 2022-04-28
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-11
• Last Update Posted: 2022-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• Diagnoses involving sleep disturbance or psychiatric anxiety

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the impact of story reading on preoperative anxiety in hip and knee surgery patients	15 minutes	Compare preoperative Amsterdam Preoperative Anxiety and Information Scale (APAIS) scores of patients undergoing hip or knee surgery who have read previous patients' stories to those who have not read the stories. The APAIS anxiety anxiety scale can have a range from 4 to 20, with higher scores indicating a higher anxiety score. The cutoff score for identifying anxious patients in a clinical practice is typically 11.
Determine the impact of story reading on preoperative sleep in hip and knee surgery patients	15 minutes	Compare preoperative Pittsburgh Sleep Quality Index scores of patients undergoing hip or knee surgery who have read previous patients' stories to those who have not read the stories.The PSQI score can range from a minimum of 0 and a maximum of 21, with a score of 5 or higher being indicative of poor sleep quality.

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States