Effect of a Pre-operative Internet-based Educational Video on Post Operative Opioid Consumption

March 10, 2026 updated by: Dr. Ahtsham Niazi, Sunnybrook Health Sciences Centre

Effect of a Pre-operative Internet-based Educational Video, Providing Both Opioid Counselling and Pain Coping Skills, on Post-operative Opioid Consumption

One of the most challenging issues in modern medicine is the current opioid epidemic. Given the association between opioid use after surgery and the development of opioid addiction, an essential goal of the medical community should be to develop strategies aimed at instructing the safe use of opioids. In addition, instructions on how to use non-opioid painkillers and exercises and techniques to better cope with pain can be used to reduce the patients opioid requirements after surgery. This study aims to evaluate the effect of providing an online educational video presentation to patients prior to surgery. This will be a 30 minute video which will provide the study participants with instructions on how best to use their opioid and non-opioid medication for pain and also teach the study participants exercises and techniques to better cope with their pain. This intervention will be used with a view to reduce the amount of opioids used by patients following hip or knee replacement surgery. Participants will be followed during their immediate phase after surgery to determine how much pain killers the participants have used and at six weeks the participants will be asked to return their unused opioids to see how much the participants have used in total.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must be adults (> 18 years of age) undergoing knee or hip arthroplasty.
  • Patients will be ASA 1-3 undergoing elective surgery.
  • English speaking patients with internet and computer access at home will be included.
  • Patients with pre-existing psychological conditions who receive either pharmaceutical or talk-based therapy will be included.
  • Patients must meet a minimum cognitive capacity to understand the instructions for the Opioid Counseling and Pain Coping Skills presentation. This will be assessed by the administration of the Montreal Cognitive Assessment during screening (MoCA), whereby a minimum score of 18 will be required to meet inclusion into the study.

Exclusion Criteria:

  • Significant cognitive impairment.
  • Chronic pain, long-term opioid therapy
  • Renal replacement therapy
  • Standing opioid requirements
  • Neuropathic pain
  • Fractures requiring emergency surgery
  • End stage cardiac or respiratory disease
  • Severe hepatic dysfunction,
  • Patients with severe psychiatric disorders
  • Vision loss
  • Allergy to local anesthesia.
  • Patients who refuse to consent to neuraxial anesthesia and/or peripheral nerve blocks will also be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Opioid Counseling and PCS Video Group
This arm of the study will receive the opioid counseling and pain coping skills video 2 weeks prior to their surgery in addition to the conventional information provided to all patients undergoing total joint arthroplasty.
Other: Opioid Counseling and Pain Coping Skills Video
The intervention will be in the form of a video of a PowerPoint presentation with instructions and exercises designed to coach patients about catastrophizing, coping skills, mindfulness and behavioral modification techniques, in addition to providing education regarding postoperative analgesia and opioid use.
No Intervention: Standard of Care Group
This arm of the study will the conventional information provided to all patients undergoing total joint arthroplasty.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post operative opioid consumption
Time Frame: From surgery until 72 hours postoperatively.
Total opioid consumption during the first 72 hours following THA or TKA surgery, measured in oral morphine equivalents.
From surgery until 72 hours postoperatively.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: On postoperative days 1/2/3, and 1- and 6-week follow-up.
Using the Visual Analog Scale (VAS) for Pain Assessment from 0 to 10 with 0 being no pain and 10 being extreme pain.
On postoperative days 1/2/3, and 1- and 6-week follow-up.
Length of hospital stay
Time Frame: From day of admission until 72 hours postoperatively.
Length of Stay from day of hospital admission to day of hospital discharge.
From day of admission until 72 hours postoperatively.
Time to first opioid demand dose
Time Frame: In the first 24 hours after surgery.
The number of hours from the time of surgery to the participants requesting their first opioid dose, either in the post-anesthesia care unit or the ward.
In the first 24 hours after surgery.
Post-operative complication rate
Time Frame: 24 hours after surgery, and 1/6 week follow-ups.
The incidence of postoperative complications, including events possibly related to opioid consumption.
24 hours after surgery, and 1/6 week follow-ups.
Total opioid consumption at 6-week follow-up
Time Frame: 6 weeks after surgery.
The total opioid consumption, reported at the 6 week follow-up.
6 weeks after surgery.
Need for rescue opioid breakthrough therapy
Time Frame: From surgery until 24 hours postoperatively.
The need for rescue opioid breakthrough therapy in the first 24 hours after surgery, assessed as a binary (yes/no) outcome.
From surgery until 24 hours postoperatively.
Participant Compliance
Time Frame: Day of surgery
Participant compliance, defined as whether or not participants in the experimental group viewed the study video.
Day of surgery
Participant satisfaction at baseline
Time Frame: Baseline (up to 1 week before surgery).
Participants' satisfaction with the study video, assessed using a questionnaire. The questionnaire contains seven statements regarding the acceptability of the study video, with responses on a 5-point Likert scale from "highly agree" to "highly disagree." Only participants in the experimental group complete the satisfaction questionnaire.
Baseline (up to 1 week before surgery).
Participant satisfaction at 1 week
Time Frame: 1 week after surgery.
Participants' satisfaction with the study video, assessed using a questionnaire. The questionnaire contains seven statements regarding the acceptability of the study video, with responses on a 5-point Likert scale from "highly agree" to "highly disagree." Only participants in the experimental group complete the satisfaction questionnaire.
1 week after surgery.
Participant satisfaction at 6 weeks
Time Frame: 6 weeks after surgery.
Participants' satisfaction with the study video, assessed using a questionnaire. The questionnaire contains seven statements regarding the acceptability of the study video, with responses on a 5-point Likert scale from "highly agree" to "highly disagree." Only participants in the experimental group complete the satisfaction questionnaire.
6 weeks after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5218

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings