NCT04180527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

November 20, 2019

Last Update Submit

August 11, 2022

Conditions

Keywords

preoperativesleepanxietyhip surgeryknee surgerystorytelling

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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.

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Diagnoses involving sleep disturbance or psychiatric anxiety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (2)

  • 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.

    PMID: 8623940BACKGROUND
  • 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.

    PMID: 2748771BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Staff Anesthesiologist; Director of Perioperative Surgical Home

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 27, 2019

Study Start

February 25, 2019

Primary Completion

April 28, 2022

Study Completion

April 28, 2022

Last Updated

August 15, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations