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

Primary Purpose

Chronic Rhinosinusitis (Diagnosis)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Video Education
Control
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis (Diagnosis)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Saint Paul's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Video Group

Arm Description

Standard of care patient education with verbal and written education

Patient education supplemented with four short youtube videos regarding chronic rhinosinusitis and endoscopic sinus surgery

Outcomes

Primary Outcome Measures

Pre-operative Patient Anxiety
Measured with State Trait Anxiety Inventory (range 20-80, higher score shows higher anxiety)
Pre-operative Patient Anxiety
Visual Analogue Scale (1-10, higher score means higher anxiety)

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2020
Last Updated
October 30, 2020
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04595461
Brief Title
Effect of Patient Education Videos on Perioperative Anxiety in Patients Undergoing Endoscopic Sinus Surgery
Official Title
Effect of Patient Education Videos on Perioperative Anxiety in Patients Undergoing
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis (Diagnosis)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Standard of care patient education with verbal and written education
Arm Title
Video Group
Arm Type
Experimental
Arm Description
Patient education supplemented with four short youtube videos regarding chronic rhinosinusitis and endoscopic sinus surgery
Intervention Type
Other
Intervention Name(s)
Video Education
Intervention Description
Patients receive four short YouTube videos explaining chronic rhinosinusitis and endoscopic sinus surgery
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Standard patient education with verbal and written education
Primary Outcome Measure Information:
Title
Pre-operative Patient Anxiety
Description
Measured with State Trait Anxiety Inventory (range 20-80, higher score shows higher anxiety)
Time Frame
1 hour preoperatively
Title
Pre-operative Patient Anxiety
Description
Visual Analogue Scale (1-10, higher score means higher anxiety)
Time Frame
1 hour preoperatively
Secondary Outcome Measure Information:
Title
Post-operative Anxiety
Description
Measured with State Trait Anxiety Inventory (range 20-80, higher score shows higher anxiety)
Time Frame
1 week post-operative
Title
Post-operative Anxiety
Description
Visual Analogue Scale (1-10, higher score means higher anxiety)
Time Frame
1 week post-operative
Title
Post-operative Pain
Description
Measured via Visual Analogue Scale (1-10, higher score means worse pain)
Time Frame
1 week post-operative
Title
Post-operative Satisfaction
Description
Measured via Visual Analogue Scale (1-10, higher score means better satisfaction)
Time Frame
1 week post-operative
Title
Post-operative medication adherence
Description
Measured via frequency of nasal irrigation per day
Time Frame
1 week post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Thamboo, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Information can be shared with other researchers on reasonable request

Learn more about this trial

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

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