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Completed

NCT Number: NCT04180527

Preoperative Hip Knee Anxiety Sleep Study

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Diagnoses involving sleep disturbance or psychiatric anxiety

Treatment and study plan

Primary outcomes

  1. Determine the impact of story reading on preoperative anxiety in hip and knee surgery patients

    Time frame: 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.

  2. Determine the impact of story reading on preoperative sleep in hip and knee surgery patients

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

Reducing Patient Anxiety Through Patients Telling Their Stories

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 27, 2019
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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