Effect of Patient Education Videos on Perioperative Anxiety in Patients Undergoing Endoscopic Sinus Surgery

Effect of Patient Education Videos on Perioperative Anxiety in Patients Undergoing

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.

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis (Diagnosis)
• Intervention / Treatment: Other: Control; Other: Video Education

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Saint Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control; Standard of care patient education with verbal and written education	Other: Control; Standard patient education with verbal and written education
EXPERIMENTAL: Video Group; Patient education supplemented with four short youtube videos regarding chronic rhinosinusitis and endoscopic sinus surgery	Other: Video Education; Patients receive four short YouTube videos explaining chronic rhinosinusitis and endoscopic sinus surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Anxiety	Measured with State Trait Anxiety Inventory (range 20-80, higher score shows higher anxiety)	1 week post-operative
Post-operative Anxiety	Visual Analogue Scale (1-10, higher score means higher anxiety)	1 week post-operative
Post-operative Pain	Measured via Visual Analogue Scale (1-10, higher score means worse pain)	1 week post-operative
Post-operative Satisfaction	Measured via Visual Analogue Scale (1-10, higher score means better satisfaction)	1 week post-operative
Post-operative medication adherence	Measured via frequency of nasal irrigation per day	1 week post-operative

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): May 1, 2020
• Study Completion (ACTUAL): May 1, 2020

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (ACTUAL): October 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Chronic Disease
• Other Study ID Numbers: H17-03567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Information can be shared with other researchers on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No