Patient EmpowermentNCT05202080
Effect of a Pre-operative Internet-based Educational Video on Post Operative Opioid Consumption
A study testing Opioid Counseling and Pain Coping Skills Video in people with Patient Empowerment, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Empowerment
- What is being tested?
- Opioid Counseling and Pain Coping Skills Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2022to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- Significant cognitive impairment.
- Chronic pain, long-term opioid therapy
- Renal replacement therapy
- Standing opioid requirements
- Neuropathic pain
- Fractures requiring emergency surgery
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Patient Empowerment
- Being tested
- Opioid Counseling and Pain Coping Skills Video
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Counseling and Pain Coping Skills VideoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Opioid Counseling and PCS Video Group | Experimental | 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. Receives: Other: Opioid Counseling and Pain Coping Skills Video |
| Standard of Care Group | No intervention | This arm of the study will the conventional information provided to all patients undergoing total joint arthroplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative opioid consumption
Total opioid consumption during the first 72 hours following THA or TKA surgery, measured in oral morphine equivalents.
Measured: From surgery until 72 hours postoperatively.
Secondary outcomes (10)
Postoperative Pain
Using the Visual Analog Scale (VAS) for Pain Assessment from 0 to 10 with 0 being no pain and 10 being extreme pain.
Measured: On postoperative days 1/2/3, and 1- and 6-week follow-up.
Length of hospital stay
Length of Stay from day of hospital admission to day of hospital discharge.
Measured: From day of admission until 72 hours postoperatively.
Time to first opioid demand dose
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.
Measured: In the first 24 hours after surgery.
Post-operative complication rate
The incidence of postoperative complications, including events possibly related to opioid consumption.
Measured: 24 hours after surgery, and 1/6 week follow-ups.
Total opioid consumption at 6-week follow-up
The total opioid consumption, reported at the 6 week follow-up.
Measured: 6 weeks after surgery.
Need for rescue opioid breakthrough therapy
The need for rescue opioid breakthrough therapy in the first 24 hours after surgery, assessed as a binary (yes/no) outcome.
Measured: From surgery until 24 hours postoperatively.
Participant Compliance
Participant compliance, defined as whether or not participants in the experimental group viewed the study video.
Measured: Day of surgery
Participant satisfaction at baseline
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.
Measured: Baseline (up to 1 week before surgery).
Participant satisfaction at 1 week
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.
Measured: 1 week after surgery.
Participant satisfaction at 6 weeks
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.
Measured: 6 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start20 Sep 2022
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EmpowermentStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ahtsham Niazi, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202080
- Sponsor's protocol ID
- 5218
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2022
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Pre-operative Internet-based Educational Video, Providing Both Opioid Counselling and Pain Coping Skills, on Post-operative Opioid Consumption
- ClinicalTrials.gov ID
- NCT05202080
- Acronym / sponsor ID
- 5218
- Conditions
- Patient Empowerment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Jan 2022 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid Counseling and PCS Video Group | Experimental | Other: Opioid Counseling and Pain Coping Skills VideoThis 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. |
| Standard of Care Group | No intervention | –This arm of the study will the conventional information provided to all patients undergoing total joint arthroplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- Significant cognitive impairment.
- Chronic pain, long-term opioid therapy
- Renal replacement therapy
- Standing opioid requirements
- Neuropathic pain
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 |
|---|---|---|
| Opioid Counseling and Pain Coping Skills VideoThe 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. | Other | Opioid Counseling and PCS Video Group |
Primary outcome
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.
10 secondary outcomes
Postoperative Pain
Time frame: 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.
Time to first opioid demand dose
Time frame: In the first 24 hours after surgery.
Post-operative complication rate
Time frame: 24 hours after surgery, and 1/6 week follow-ups.
Total opioid consumption at 6-week follow-up
Time frame: 6 weeks after surgery.
Need for rescue opioid breakthrough therapy
Time frame: From surgery until 24 hours postoperatively.
Participant Compliance
Time frame: Day of surgery
Participant satisfaction at baseline
Time frame: Baseline (up to 1 week before surgery).
Participant satisfaction at 1 week
Time frame: 1 week after surgery.
Participant satisfaction at 6 weeks
Time frame: 6 weeks after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Counseling and Pain Coping Skills Video in people with Patient Empowerment, run by Sunnybrook Health Sciences Centre 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 5 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Post operative opioid consumption (time frame: From surgery until 72 hours postoperatively.). 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 12 Mar 2026.