Clinical trial NCT04180527: Preoperative Hip Knee Anxiety Sleep Study
Official title: Reducing Patient Anxiety Through Patients Telling Their Stories
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Sleep
Surgery
Keywords: preoperative
sleep
anxiety
hip surgery
knee surgery
storytelling
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will focus on patients who undergo full hip or knee arthroplasty at Henry Ford Hospital and do not have any diagnoses involving sleep disturbance or psychiatric anxiety.

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.

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

Primary outcomes:
measure: Determine the impact of story reading on preoperative anxiety in hip and knee surgery patients
timeFrame: 15 minutes
measure: Determine the impact of story reading on preoperative sleep in hip and knee surgery patients
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
References:
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. doi: 10.1097/00000539-199603000-00002.
citation: 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.