Effect of Patient Education Videos on Perioperative Anxiety in Patients Undergoing Endoscopic Sinus Surgery
1 other identifier
interventional
80
1 country
1
Brief Summary
Chronic rhinosinusitis treatment consists of medical management and surgical intervention. Improving patient education can positively impact perioperative patient experiential outcomes such as anxiety, pain and satisfaction. However, online education materials are often too complex, inaccurate or misleading. The objective of this study was to determine if patient education videos at an appropriate reading level would improve perioperative anxiety in patients undergoing endoscopic sinus surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 8, 2020
CompletedFirst Posted
Study publicly available on registry
October 20, 2020
CompletedNovember 3, 2020
October 1, 2020
3 years
September 8, 2020
October 30, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Pre-operative Patient Anxiety
Measured with State Trait Anxiety Inventory (range 20-80, higher score shows higher anxiety)
1 hour preoperatively
Pre-operative Patient Anxiety
Visual Analogue Scale (1-10, higher score means higher anxiety)
1 hour preoperatively
Secondary Outcomes (5)
Post-operative Anxiety
1 week post-operative
Post-operative Anxiety
1 week post-operative
Post-operative Pain
1 week post-operative
Post-operative Satisfaction
1 week post-operative
Post-operative medication adherence
1 week post-operative
Study Arms (2)
Control
PLACEBO COMPARATORStandard of care patient education with verbal and written education
Video Group
EXPERIMENTALPatient education supplemented with four short youtube videos regarding chronic rhinosinusitis and endoscopic sinus surgery
Interventions
Patients receive four short YouTube videos explaining chronic rhinosinusitis and endoscopic sinus surgery
Eligibility Criteria
You may qualify if:
- years of age or older
- English speaking
- diagnosed with CRS according to Canadian Guidelines
- computer or mobile phone access were included
You may not qualify if:
- immunocompromised
- had sinonasal tumours
- history of anxiety, depression, bipolar, or any other mental illnesses
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Thamboo, MD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor, Division of Otolaryngology-Head and Neck Surgery
Study Record Dates
First Submitted
September 8, 2020
First Posted
October 20, 2020
Study Start
May 1, 2017
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
November 3, 2020
Record last verified: 2020-10