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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04595461
Other study ID # H17-03567
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date May 1, 2020

Study information

Verified date October 2020
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or older - English speaking - diagnosed with CRS according to Canadian Guidelines - computer or mobile phone access were included Exclusion Criteria: - immunocompromised - had sinonasal tumours - history of anxiety, depression, bipolar, or any other mental illnesses

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Video Education
Patients receive four short YouTube videos explaining chronic rhinosinusitis and endoscopic sinus surgery
Control
Standard patient education with verbal and written education

Locations

Country Name City State
Canada Saint Paul's Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pre-operative Patient Anxiety Measured with State Trait Anxiety Inventory (range 20-80, higher score shows higher anxiety) 1 hour preoperatively
Primary Pre-operative Patient Anxiety Visual Analogue Scale (1-10, higher score means higher anxiety) 1 hour preoperatively
Secondary Post-operative Anxiety Measured with State Trait Anxiety Inventory (range 20-80, higher score shows higher anxiety) 1 week post-operative
Secondary Post-operative Anxiety Visual Analogue Scale (1-10, higher score means higher anxiety) 1 week post-operative
Secondary Post-operative Pain Measured via Visual Analogue Scale (1-10, higher score means worse pain) 1 week post-operative
Secondary Post-operative Satisfaction Measured via Visual Analogue Scale (1-10, higher score means better satisfaction) 1 week post-operative
Secondary Post-operative medication adherence Measured via frequency of nasal irrigation per day 1 week post-operative
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