NCT04595461

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

3 years

First QC Date

September 8, 2020

Last Update Submit

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 COMPARATOR

Standard of care patient education with verbal and written education

Other: Control

Video Group

EXPERIMENTAL

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

Other: Video Education

Interventions

Patients receive four short YouTube videos explaining chronic rhinosinusitis and endoscopic sinus surgery

Video Group
ControlOTHER

Standard patient education with verbal and written education

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew Thamboo, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

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

Locations