Preoperative Hip Knee Anxiety Sleep Study

Anxiety Clinical Trial

Official title:

Reducing Patient Anxiety Through Patients Telling Their Stories

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180527
• Other study ID #: 12849
• Status: Completed
• Start date: February 25, 2019
• Est. completion date: April 28, 2022

Study information

• Verified date: August 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Diagnoses involving sleep disturbance or psychiatric anxiety

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Sleep
• Surgery

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the impact of story reading on preoperative anxiety in hip and knee surgery patients	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.	15 minutes
Primary	Determine the impact of story reading on preoperative sleep in hip and knee surgery patients	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.	15 minutes