AnxietyNCT04424810
Effect of High-quality Pre-operative Videos on Patient Anxiety Levels Prior to Ambulatory Hand Surgery
A study testing High-quality, physician created video in people with Anxiety and Carpal Tunnel Syndrome, run by Northwell Health at 1 site in United States.
Trial summary
Previous research has shown that YouTube is a poor source of high-quality medical information. This is likely because there is no regulation of the content on YouTube and relatively little of the content is posted by qualified medical professionals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Carpal Tunnel Syndrome, Trigger Finger
- What is being tested?
- High-quality, physician created video
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 1 Jul 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergoing a primary routine elective hand procedure (Carpal tunnel release, trigger finger release)
- age > 18 years
Who cannot join
- revision procedure
- prior debilitating upper extremity injury
- surgery not being performed on ambulatory basis
- special populations (pregnant patients, prisoners or other institutionalized patients, cognitive impairment)
- non-english speaking patients (videos only available in english language)
- age < 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore University Hospital, Schwartz Ambulatory Surgery Center
Manhasset, New York, 11030
About this study
Previous research has shown that YouTube is a poor source of high-quality medical information. This is likely because there is no regulation of the content on YouTube and relatively little of the content is posted by qualified medical professionals. It is known that up to 30% of patients use the internet to research the procedure they will be having and given the increasing popularity of YouTube we suspect many patients are using YouTube or similar sites as a source of information prior to elective surgery. There are likely a number of patient factors that contribute to patients seeking out videos as a source of pre-operative medical information. Patient age, which is generally inversely correlated to computer literacy, may have a role. Patient anxiety and pre-operative worrying may cause a patient to turn to the internet to search for information, and the poor overall quality of the content available may worsen pre-operative anxiety.
The primary objective of this study is to determine if providing patients with a reliable, high-quality video about their condition and operation prior to surgery reduces pre-operative anxiety. Secondary aims are to determine the percentage of patients that independently seek out videos online as a source of medical information prior to elective hand surgery, identify patient attributes that are associated with this behavior, and understand if introducing high quality pre-surgical videos has an impact on post-operative patient outcomes and/or patient engagement. The investigators hypothesize that providing patients with high-quality pre-operative videos will reduce pre-operative anxiety. Its is also expected that patients who seek out videos on their own for pre-operative medical information will be younger and have higher anxiety levels and pain catastrophizing scores. Additionally, the investigators hypothesize that patients who watch high-quality pre-operative videos may have better short term post-operative outcomes and greater engagement in their care than their counterparts that did not watch videos or who sought out videos on their own.
- Conditions
- Anxiety, Carpal Tunnel Syndrome, Trigger Finger, Engagement, Patient, Pain
- Being tested
- High-quality, physician created video, Standard of care
- Medical subject headings
- Anxiety Disorders, Carpal Tunnel Syndrome, Trigger Finger Disorder, Patient Participation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-quality, physician created videoOther
The intervention group will watch a short (2-5 minute) video prior to surgery that will provide them with information about their condition and the procedure they are about to undergo (either carpal tunnel release or trigger finger release).
Standard of careOther
Patients in the control group will not be asked to do anything differently prior to their surgery
| Study group | Role | What they receive |
|---|---|---|
| Video group | Experimental | Patients selected to be in the intervention group will be asked to watch a high-quality, physician created video describing their condition and the operative treatment they are about to undergo. Receives: Other: High-quality, physician created video |
| Control group | Placebo comparator | Patients selected to be in the control group will not be asked to watch a video prior to surgery. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative anxiety
We will measure pre-operative anxiety using the State-Trait Anxiety Inventory (STAI) 6-item short form (minimum score: 20, maximum score: 80, higher scores indicate more anxiety)
Measured: Immediately prior to surgery
Secondary outcomes (5)
Percentage of patients who sought out pre-operative videos before surgery
We plan to determine the percentage of patients who sought out pre-operative videos before surgery on websites such as YouTube as a part of our "video questionnaire"
Measured: Immediately before surgery
Pain catastrophizing
As determined by the pain catastrophizing scale (PCS); (minimum score: 0, maximum score: 100, higher scores indicate more anxiety)
Measured: Immediately before surgery
Patient engagement
To determine patient levels of engagement in their care as assessed by the Patient Activation Measure (PAM)-13 (minimum score: 0, maximum score: 100, higher scores indicate higher levels of activation/engagement in care)
Measured: Immediately before surgery
Pain scores
Assessed by Visual Analog Scale (VAS) pain scores (minimum: 0, maximum: 10, higher scores indicate greater levels of pain)
Measured: At 48-72 hour post-operatively and 2 weeks post-operatively
Functional outcomes
Assessed by the Quick Disabilities of the Arm, Shoulder and Hand (qDASH) questionnaire (minimum: 0, maximum: 100, greater scores indicate a greater level of disability)
Measured: At 48-72 hour post-operatively and 2 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jul 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, 2 groups, 1:1 randomization
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Larsen, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424810
- Sponsor's protocol ID
- 20-0516
- Status last verified
- Sep 2021
- First submitted
- 3 Jun 2020
- Last updated
- 5 Sep 2021
- 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 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-quality Pre-operative Videos on Patient Anxiety Levels Prior to Ambulatory Hand Surgery
- ClinicalTrials.gov ID
- NCT04424810
- Acronym / sponsor ID
- 20-0516
- Conditions
- Anxiety, Carpal Tunnel Syndrome, Trigger Finger, Engagement, Patient, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 11 Jun 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.
Previous research has shown that YouTube is a poor source of high-quality medical information. This is likely because there is no regulation of the content on YouTube and relatively little of the content is posted by qualified medical professionals. It is known that up to 30% of patients use the internet to research the procedure they will be having and given the increasing popularity of YouTube we suspect many patients are using YouTube or similar sites as a source of information prior to elective surgery. There are likely a number of patient factors that contribute to patients seeking out videos as a source of pre-operative medical information. Patient age, which is generally inversely correlated to computer literacy, may have a role. Patient anxiety and pre-operative worrying may cause a patient to turn to the internet to search for information, and the poor overall quality of the content available may worsen pre-operative anxiety.
The primary objective of this study is to determine if providing patients with a reliable, high-quality video about their condition and operation prior to surgery reduces pre-operative anxiety. Secondary aims are to determine the percentage of patients that independently seek out videos online as a source of medical information prior to elective hand surgery, identify patient attributes that are associated with this behavior, and understand if introducing high quality pre-surgical videos has an impact on post-operative patient outcomes and/or patient engagement. The investigators hypothesize that providing patients with high-quality pre-operative videos will reduce pre-operative anxiety. Its is also expected that patients who seek out videos on their own for pre-operative medical information will be younger and have higher anxiety levels and pain catastrophizing scores. Additionally, the investigators hypothesize that patients who watch high-quality pre-operative videos may have better short term post-operative outcomes and greater engagement in their care than their counterparts that did not watch videos or who sought out videos on their own.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel, 2 groups, 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Video group | Experimental | Other: High-quality, physician created videoPatients selected to be in the intervention group will be asked to watch a high-quality, physician created video describing their condition and the operative treatment they are about to undergo. |
| Control group | Placebo comparator | Other: Standard of carePatients selected to be in the control group will not be asked to watch a video prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- undergoing a primary routine elective hand procedure (Carpal tunnel release, trigger finger release)
- age > 18 years
Key exclusion criteria (6 listed)
- revision procedure
- prior debilitating upper extremity injury
- surgery not being performed on ambulatory basis
- special populations (pregnant patients, prisoners or other institutionalized patients, cognitive impairment)
- non-english speaking patients (videos only available in english language)
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 |
|---|---|---|
| High-quality, physician created videoThe intervention group will watch a short (2-5 minute) video prior to surgery that will provide them with information about their condition and the procedure they are about to undergo (either carpal tunnel release or trigger finger release). | Other | Video group |
| Standard of carePatients in the control group will not be asked to do anything differently prior to their surgery | Other | Control group |
Primary outcome
Pre-operative anxiety
Time frame: Immediately prior to surgery
We will measure pre-operative anxiety using the State-Trait Anxiety Inventory (STAI) 6-item short form (minimum score: 20, maximum score: 80, higher scores indicate more anxiety)
5 secondary outcomes
Percentage of patients who sought out pre-operative videos before surgery
Time frame: Immediately before surgery
Pain catastrophizing
Time frame: Immediately before surgery
Patient engagement
Time frame: Immediately before surgery
Pain scores
Time frame: At 48-72 hour post-operatively and 2 weeks post-operatively
Functional outcomes
Time frame: At 48-72 hour post-operatively and 2 weeks post-operatively
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 5 Sep 2021.
- 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 High-quality, physician created video in people with Anxiety and Carpal Tunnel Syndrome, run by Northwell Health at 1 site in United States.
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 2 inclusion and 6 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 5 Sep 2021. 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 United States. 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 anxiety (time frame: Immediately prior to surgery). 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 5 Sep 2021.