Carpal Tunnel SyndromeNCT06582550
Effectiveness of Audiovisual Versus Written Postoperative Instructions for Patients Undergoing Minor Hand Procedures
A study testing Minor Hand Procedure in people with Carpal Tunnel Syndrome and Hand Cyst Ganglion, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
Trial summary
The utility and effectiveness of video-based instructions (VBI) versus standard written instructions was not previously investigated in hand surgery; thus, the objective of this study is to evaluate the effectiveness of audiovisual instruction as compared to regular verbal instructions given to patients undergoing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome, Hand Cyst Ganglion, Trigger Finger
- What is being tested?
- Minor Hand Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 19 Sep 2024to 2 Jan 2026
- 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
- Please ensure that ALL items below are satisfied to be included in the study.
- Patient undergoing hand and/or upper extremity surgery with Dr. Thibaudeau
- Patient ≥ 18 years old
- Patient who comprehends instructions provided in English and/or French
- Patient who can navigate the internet to complete an online post-operative questionnaire
Who cannot join
- Please ensure that NONE of the following items are selected to be included in the study.
- Patient presenting with intra-articular, open, or pathological fractures
- Patient presenting with associated tendon or nerve injuries
- Patient receiving definitive surgery ≥21 days after injury
- Patient with previous surgeries/deformity in the hand
- Patient with pre-existing severe joint disease (rheumatoid arthritis, finger joint stiffness, or non-union)
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- Patient with medical contraindications to surgery
- Patient who is unable to comply with rehabilitation
- Patient who is unwilling to be followed up
- Patient with dementia
- Patient with significant mental illness
- Patient who is unable to provide informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Audiovisual Versus Written Postoperative Instructions for Patients Undergoing Minor Hand Procedures: a Prospective Controlled Trial
The utility and effectiveness of video-based instructions (VBI) versus standard written instructions was not previously investigated in hand surgery; thus, the objective of this study is to evaluate the effectiveness of audiovisual instruction as compared to regular verbal instructions given to patients undergoing common hand procedures, including instruction recall and compliance, patient education, patient satisfaction with the information given, patient satisfaction with operative experience.
Read the detailed description
Outcomes of hand surgery are greatly dependent on factors outside the operating theater as well. These include patient compliance to preoperative instructions that consist of proper surgical site care, proper positioning, and following occupational therapy protocols. Previous studies have shown that video-based information provide greater patient satisfaction than verbal instructions. Visual information was also reported to decrease patient anxiety regarding the procedure and increases patient education in terms of procedure risks and benefits(1-5). The utility and effectiveness of video-based instructions (VBI) versus standard written instructions was not previously investigated in hand surgery; thus, the objective of this study is to evaluate the effectiveness of audiovisual instruction as compared to regular verbal instructions given to patients undergoing common hand procedures, including instruction recall and compliance, patient education, patient satisfaction with the information given, patient satisfaction with operative experience. The secondary objective is to evaluate if VBI result in better outcomes than standard written instructions.
- Conditions
- Carpal Tunnel Syndrome, Hand Cyst Ganglion, Trigger Finger
- Being tested
- Minor Hand Procedure
- Medical subject headings
- Carpal Tunnel Syndrome, Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minor Hand ProcedureProcedure or surgery
Unilateral minor hand procedure (carpal tunnel release, trigger finger A1 pulley release, lesion excision)
| Study group | Role | What they receive |
|---|---|---|
| Audiovisual Instruction Group | Experimental | Patients who require a hand surgery presenting to the clinic will be divided randomly; each participant is assigned by opening a prepared envelope with a dedicated group randomly, if the patient is assigned to group 1, they will receive standard printed instructions regarding their expected postoperative care, but if the patient is assigned to group 2, they will be provided with a barcode to scan to view audiovisual instructions regarding their post-operative course Receives: Procedure: Minor Hand Procedure |
| Written Instruction Group | Active comparator | Patients who require a hand surgery presenting to the clinic will be divided randomly; each participant is assigned by opening a prepared envelope with a dedicated group randomly, if the patient is assigned to group 1, they will receive standard printed instructions regarding their expected postoperative care, but if the patient is assigned to group 2, they will be provided with a barcode to scan to view audiovisual instructions regarding their post-operative course Receives: Procedure: Minor Hand Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction with the operative experience
Questionnaire to assess patient satisfaction with the operative experience will be distributed within a week in post operative visit
Measured: within 1 week
patient instruction recall
Questionnaire to assess patient instruction recall will be distributed within a week in post operative visit. It consists of 9 questions, the maximum score is 9 and indicates excellent recall.
Measured: within 1 week
patient satisfaction with the information given
Questionnaire to assess patient satisfaction with the information givenwill be distributed within a week in post operative visit
Overall, are you satisfied with the provided post-operative instructions for your hand surgery? Likert-scale 1-10 (with smile face) Overall, were the provided post-operative instructions for your hand surgery easy to understand? Likert-scale 1-10 (with smile face) Overall, did the provided post-operative instructions for your hand surgery had the appropriate amount of information? Likert-scale 1-10 (with smile face)
Measured: within 1 week
patient compliance
Questionnaire to assess patient instruction compliance will be distributed within a week in post operative visit. It consists of 13 questions, each with a score, with 13 being thre maximum patient compliance.
Measured: within 1 week
Secondary outcomes (2)
Nursing staff patient experience
Nursing staff will be asked to present which patients reached out to clinic number/email with questions and if the instrutions decreased the incidence of such
Assessed as binomial outcome
Have you called your surgeon's office post-operatively regarding any unexpected post-operative course? Yes No Unsure
Measured: within 3 months
Dash Scores
Questionnaire to assess patient outcome will be distributed within a week in post operative visit
Quick dash score
QuickDASH DISABILITY/SYMPTOM SCORE= (sum of n responses) - 1 x 25, wherenis equal to the number of completed responses.
Measured: within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start19 Sep 2024 (estimated)
- Primary completion19 Sep 2025 (estimated)
- Study completion2 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Note that the surgical intervention is the same in both study arms. The comparison is in regards to the post-operative instructions with the aim of quality improvement.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Thibaudeau, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582550
- Sponsor's protocol ID
- 2025-10990
- Other IDs
- 2025
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Audiovisual Versus Written Postoperative Instructions for Patients Undergoing Minor Hand Procedures: a Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT06582550
- Acronym / sponsor ID
- 2025-10990
- Conditions
- Carpal Tunnel Syndrome, Hand Cyst Ganglion, Trigger Finger
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 19 Sep 2024 (estimated)
- Primary completion
- 19 Sep 2025 (estimated)
- Study completion
- 2 Jan 2026 (estimated)
- First posted
- 3 Sep 2024 (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.
The utility and effectiveness of video-based instructions (VBI) versus standard written instructions was not previously investigated in hand surgery; thus, the objective of this study is to evaluate the effectiveness of audiovisual instruction as compared to regular verbal instructions given to patients undergoing common hand procedures, including instruction recall and compliance, patient education, patient satisfaction with the information given, patient satisfaction with operative experience.
Detailed description
Outcomes of hand surgery are greatly dependent on factors outside the operating theater as well. These include patient compliance to preoperative instructions that consist of proper surgical site care, proper positioning, and following occupational therapy protocols. Previous studies have shown that video-based information provide greater patient satisfaction than verbal instructions. Visual information was also reported to decrease patient anxiety regarding the procedure and increases patient education in terms of procedure risks and benefits(1-5). The utility and effectiveness of video-based instructions (VBI) versus standard written instructions was not previously investigated in hand surgery; thus, the objective of this study is to evaluate the effectiveness of audiovisual instruction as compared to regular verbal instructions given to patients undergoing common hand procedures, including instruction recall and compliance, patient education, patient satisfaction with the information given, patient satisfaction with operative experience. The secondary objective is to evaluate if VBI result in better outcomes than standard written instructions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Note that the surgical intervention is the same in both study arms. The comparison is in regards to the post-operative instructions with the aim of quality improvement.
| Arm | Type | Receives |
|---|---|---|
| Audiovisual Instruction Group | Experimental | Procedure: Minor Hand ProcedurePatients who require a hand surgery presenting to the clinic will be divided randomly; each participant is assigned by opening a prepared envelope with a dedicated group randomly, if the patient is assigned to group 1, they will receive standard printed instructions regarding their expected postoperative care, but if the patient is assigned to group 2, they will be provided with a barcode to scan to view audiovisual instructions regarding their post-operative course |
| Written Instruction Group | Active comparator | Procedure: Minor Hand ProcedurePatients who require a hand surgery presenting to the clinic will be divided randomly; each participant is assigned by opening a prepared envelope with a dedicated group randomly, if the patient is assigned to group 1, they will receive standard printed instructions regarding their expected postoperative care, but if the patient is assigned to group 2, they will be provided with a barcode to scan to view audiovisual instructions regarding their post-operative course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Please ensure that ALL items below are satisfied to be included in the study.
- Patient undergoing hand and/or upper extremity surgery with Dr. Thibaudeau
- Patient ≥ 18 years old
- Patient who comprehends instructions provided in English and/or French
- Patient who can navigate the internet to complete an online post-operative questionnaire
Key exclusion criteria (12 listed)
- Please ensure that NONE of the following items are selected to be included in the study.
- Patient presenting with intra-articular, open, or pathological fractures
- Patient presenting with associated tendon or nerve injuries
- Patient receiving definitive surgery ≥21 days after injury
- Patient with previous surgeries/deformity in the hand
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 |
|---|---|---|
| Minor Hand ProcedureUnilateral minor hand procedure (carpal tunnel release, trigger finger A1 pulley release, lesion excision) | Procedure or surgery | Audiovisual Instruction Group, Written Instruction Group |
Primary outcome
patient satisfaction with the operative experience
Time frame: within 1 week
Questionnaire to assess patient satisfaction with the operative experience will be distributed within a week in post operative visit
patient instruction recall
Time frame: within 1 week
Questionnaire to assess patient instruction recall will be distributed within a week in post operative visit. It consists of 9 questions, the maximum score is 9 and indicates excellent recall.
patient satisfaction with the information given
Time frame: within 1 week
Questionnaire to assess patient satisfaction with the information givenwill be distributed within a week in post operative visit Overall, are you satisfied with the provided post-operative instructions for your hand surgery? Likert-scale 1-10 (with smile face) Overall, were the provided post-operative instructions for your hand surgery easy to understand? Likert-scale 1-10 (with smile face) Overall, did the provided post-operative instructions for your hand surgery had the appropriate amount of information? Likert-scale 1-10 (with smile face)
patient compliance
Time frame: within 1 week
Questionnaire to assess patient instruction compliance will be distributed within a week in post operative visit. It consists of 13 questions, each with a score, with 13 being thre maximum patient compliance.
2 secondary outcomes
Nursing staff patient experience
Time frame: within 3 months
Dash Scores
Time frame: within 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Minor Hand Procedure in people with Carpal Tunnel Syndrome and Hand Cyst Ganglion, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
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: status not confirmed, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rawan ElAbd, MD MSc (514-934-8025, plastic.surgery@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction with the operative experience (time frame: within 1 week). The study lists 4 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 Sep 2024.