- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04048538
Preoperative Patient Education Via Animated Videos to Improve Patient Satisfaction and Reduce Complications in Head and Neck Surgery
Preoperative Patient Education Via Animated Videos to Improve Patient Satisfaction and Reduce Complications in Head and Neck Surgery: a Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hypothesis/Study question:
Does the implementation of an animation based patient education platform prior to undergoing surgery lead to improved patient satisfaction and quality of life?
Study objectives:
Help address patient gaps in understanding, reduce learning barriers in order for patients to make informed decisions, improve behaviors, and better partner with their health providers to attain optimal health outcomes
Methodology / Study design:
Patients will receive access to the patient education platform during the clinical visit in which they receive their diagnosis, and will be asked if they wish to enroll in the study consisting of completing questionnaires before and after their surgical procedure. Questions will inquire on levels of anxiety, patient satisfaction, knowledge retention, and platform feedback.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individuals having any of the following surgical procedure at the Jewish General Hospital over the next 12 months: head and neck cancer resection with or without reconstruction, excision of parotid lesion, thyroidectomy, parathyroidectomy, laryngectomy, or trans-oral robotic resection.
Exclusion Criteria:
- Individuals who are undergoing a surgical procedure not included in the ones listed above, or those who are having revision surgery or have previously had surgery in the otolaryngology, head and neck surgery department.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Arm
Individuals who will receive access to the animated multimedia platform prior to their surgical procedure.
|
an innovative patient education platform using animated videos created by using up-to-date evidence-based informaiton
|
Active Comparator: Control Arm
Individuals who will not receive access to the animated patient platform, and instead will receive the usual standard of care.
|
individuals will receive treatment as per the usual standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction
Time Frame: 1 month post-operative
|
analyzed using patient questionnaire responses
|
1 month post-operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative complication rate
Time Frame: 1 month post-operative
|
analyzed using hospital data
|
1 month post-operative
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Precare
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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