Chronic Rhinosinusitis (Diagnosis)NCT04595461
Effect of Patient Education Videos on Perioperative Anxiety in Patients Undergoing Endoscopic Sinus Surgery
A study testing Video Education in people with Chronic Rhinosinusitis (Diagnosis), run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Video Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2017to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- English speaking
- diagnosed with CRS according to Canadian Guidelines
- computer or mobile phone access were included
Who cannot join
- immunocompromised
- had sinonasal tumours
- history of anxiety, depression, bipolar, or any other mental illnesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Video Education, Control
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video EducationOther
Patients receive four short YouTube videos explaining chronic rhinosinusitis and endoscopic sinus surgery
ControlOther
Standard patient education with verbal and written education
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Standard of care patient education with verbal and written education Receives: Other: Control |
| Video Group | Experimental | Patient education supplemented with four short youtube videos regarding chronic rhinosinusitis and endoscopic sinus surgery Receives: Other: Video Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative Patient Anxiety
Measured with State Trait Anxiety Inventory (range 20-80, higher score shows higher anxiety)
Measured: 1 hour preoperatively
Pre-operative Patient Anxiety
Visual Analogue Scale (1-10, higher score means higher anxiety)
Measured: 1 hour preoperatively
Secondary outcomes (5)
Post-operative Anxiety
Measured with State Trait Anxiety Inventory (range 20-80, higher score shows higher anxiety)
Measured: 1 week post-operative
Post-operative Anxiety
Visual Analogue Scale (1-10, higher score means higher anxiety)
Measured: 1 week post-operative
Post-operative Pain
Measured via Visual Analogue Scale (1-10, higher score means worse pain)
Measured: 1 week post-operative
Post-operative Satisfaction
Measured via Visual Analogue Scale (1-10, higher score means better satisfaction)
Measured: 1 week post-operative
Post-operative medication adherence
Measured via frequency of nasal irrigation per day
Measured: 1 week post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 May 2017
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Thamboo, University of British Columbia
- Investigators
- Andrew Thamboo, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595461
- Sponsor's protocol ID
- H17-03567
- Status last verified
- Oct 2020
- First submitted
- 8 Sep 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Information can be shared with other researchers on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Patient Education Videos on Perioperative Anxiety in Patients Undergoing
- ClinicalTrials.gov ID
- NCT04595461
- Acronym / sponsor ID
- H17-03567
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlStandard of care patient education with verbal and written education |
| Video Group | Experimental | Other: Video EducationPatient education supplemented with four short youtube videos regarding chronic rhinosinusitis and endoscopic sinus surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- English speaking
- diagnosed with CRS according to Canadian Guidelines
- computer or mobile phone access were included
Key exclusion criteria (3 listed)
- immunocompromised
- had sinonasal tumours
- history of anxiety, depression, bipolar, or any other mental illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video EducationPatients receive four short YouTube videos explaining chronic rhinosinusitis and endoscopic sinus surgery | Other | Video Group |
| ControlStandard patient education with verbal and written education | Other | Control |
Primary outcome
Pre-operative Patient Anxiety
Time frame: 1 hour preoperatively
Measured with State Trait Anxiety Inventory (range 20-80, higher score shows higher anxiety)
Pre-operative Patient Anxiety
Time frame: 1 hour preoperatively
Visual Analogue Scale (1-10, higher score means higher anxiety)
5 secondary outcomes
Post-operative Anxiety
Time frame: 1 week post-operative
Post-operative Anxiety
Time frame: 1 week post-operative
Post-operative Pain
Time frame: 1 week post-operative
Post-operative Satisfaction
Time frame: 1 week post-operative
Post-operative medication adherence
Time frame: 1 week post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: Undecided. Information can be shared with other researchers on reasonable request
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Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
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Enrolling by invitationObservational study
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FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Thamboo, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Education in people with Chronic Rhinosinusitis (Diagnosis), run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-operative Patient Anxiety (time frame: 1 hour preoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.