Perioperative Family Updates Reduce Anxiety and Improve Satisfaction

Anxiety Clinical Trial

Official title:

Perioperative Family Updates Reduce Anxiety and Improve Satisfaction: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04330612
• Other study ID #: CHRMS 16-642
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: August 30, 2017

Study information

• Verified date: March 2020
• Source: University of Vermont Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was a randomized control trial conducted to determine if frequent, standardized updates affect anxiety and satisfaction of family members. Additionally, the investigators aimed to determine if the length of the surgical procedure effects the satisfaction with updates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient undergoing inpatient arthroplasty, orthopaedic spine, or orthopaedic trauma procedures

Exclusion Criteria:

• Age under 18

• Non-English speaking patients or families

• Patients with families that would not be waiting in the hospital during the perioperative period

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Family Members
• Satisfaction

Intervention

Other:
• Perioperative Updates
In the intervention group, the families received additional standardized electronic updates via pagers at three pivotal moments: 1) Initial skin incision has been made; 2) Critical part of the case is completed and closure has begun; and, 3) Closure is complete, and patient will be transferred to the recovery room when ready.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Likert Score (0-5) of level of overall satisfaction	Likert Score (0-5) of level of overall satisfaction of family members throughout the perioperative period	Overall satisfaction levels measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon-family update. This update occurred at or near the end of the surgical procedure.
Primary	Likert Score (0-5) of anxiety level	Likert Score (0-5) of anxiety level of family members throughout the perioperative period	Anxiety levels measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon-family update. This update occurred at or near the end of the surgical procedure.
Primary	Likert Score (0-5) of level of satisfaction with perioperative updates	Likert Score (0-5) of level of satisfaction of family members with perioperative updates throughout the perioperative period	Satisfaction with perioperative updates measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon-family update. This update occurred at or near the end of the surgical procedure.
Secondary	Spearman correlation between length of procedure and Likert score of anxiety level	Spearman correlation between length of procedure and Likert score (0-5) of anxiety level of family members throughout the perioperative period	Procedure time defined as the time the patient enters the operating room to the time the patient exits the operating room. Anxiety levels measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon update.
Secondary	Spearman correlation between length of procedure and Likert score of overall satisfaction	Spearman correlation between length of procedure and Likert score (0-5) of overall satisfaction level of family members throughout the perioperative period	Procedure time defined as the time the patient enters the operating room to the time the patient exits the operating room. Satisfaction level measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon update.
Secondary	Spearman correlation between length of procedure and Likert score of satisfaction with perioperative updates	Spearman correlation between length of procedure and Likert score of family member satisfaction with perioperative updates	Procedure time defined as the time the patient enters the operating room to the time the patient exits the operating room. Satisfaction level measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon update.