AnxietyNCT02546180
Improving Patient Understanding of the Surgical Hospital Experience: Use of YouTube Video Playlist
A study testing Viewing YouTube videos and Standard preoperative education in people with Anxiety, run by Mayo Clinic.
Trial summary
This prospective randomized pilot clinical trial studied the effect on preoperative anxiety of watching a series of YouTube videos designed to create a virtual hospital experience for patients undergoing primary total hip and knee arthroplasty as compared to routine preoperative education. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Viewing YouTube videos and Standard preoperative education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to May 2014
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing primary total hip or total knee arthroplasty at Mayo Clinic in Florida
- Patients must be able to give consent to the study
- Patients must agree to watch the videos prior to scheduled surgery
- Patients must agree to complete the questionnaire in the office and again prior to surgery on the day of surgery
Who cannot join
- No internet access at home
- Visual or auditory conditions which limit a patient's ability to view the You Tube videos at home
About this study
This prospective randomized pilot clinical trial studied the effect on preoperative anxiety of watching a series of YouTube videos designed to create a virtual hospital experience for patients undergoing primary total hip and knee arthroplasty as compared to routine preoperative education.
Hypothesis: Preoperative anxiety related to hip and knee replacement surgeries can be reduced by patient exposure to a virtual hospital inpatient experience delivered by a series of YouTube videos.
Read the detailed description
As high patient anxiety prior to surgery has been linked to more severe and persistent pain after joint replacement surgery, the Orthopedic Surgery Department at Mayo Clinic in Florida created a playlist of 16 YouTube videos aimed at creating a virtual hospital experience for primary total hip and knee joint replacement patients. A pilot study was then performed to evaluate the potential impact of viewing this playlist on preoperative anxiety.
Methods: Each patient completed a Generalized Anxiety Disorder Score (GAD) assessment at the time of the routine preoperative clinic visit and were then randomized based on their gender, type of surgery, and initial GAD score to either the control group of standard education (education at face-to-face clinical visits as well as printed educational materials) or the treatment group of standard education plus access to the YouTube playlist. On the morning of the patient's surgery the same survey was repeated.
- Conditions
- Anxiety
- Being tested
- Viewing YouTube videos, Standard preoperative education
- Keywords
- Patient education, Preoperative anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viewing YouTube videosOther
The on-line patient education program will highlight postoperative care.
Standard preoperative educationOther
Standard preoperative education will be provided by the surgeon, physician extender and paramedical staff in the clinic.
| Study group | Role | What they receive |
|---|---|---|
| YouTube Video Viewers | Experimental | Subjects in this arm were randomized to viewing YouTube videos. Receives: Other: Viewing YouTube videos |
| Standard Education | Active comparator | Subjects in this arm were randomized to standard preoperative education. Receives: Other: Standard preoperative education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Generalized Anxiety Disorder (GAD) Score
Measured: Baseline, approximately 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary O'Connor, Mayo Clinic
- Investigators
- Mary O'Connor, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546180
- Sponsor's protocol ID
- IRB # 14-000084
- Status last verified
- Sep 2015
- First submitted
- 8 Sep 2015
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Connor MI, Brennan K, Kazmerchak S, Pratt J. YouTube Videos to Create a "Virtual Hospital Experience" for Hip and Knee Replacement Patients to Decrease Preoperative Anxiety: A Randomized Trial. Interact J Med Res. 2016 Apr 18;5(2):e10. doi: 10.2196/ijmr.4295.
PubMed 27091674
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Understanding of the Surgical Hospital Experience: Use of YouTube Video Playlist
- ClinicalTrials.gov ID
- NCT02546180
- Acronym / sponsor ID
- IRB # 14-000084
- Conditions
- Anxiety
- Keywords
- Patient education, Preoperative anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Sep 2015 (estimated)
- 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.
This prospective randomized pilot clinical trial studied the effect on preoperative anxiety of watching a series of YouTube videos designed to create a virtual hospital experience for patients undergoing primary total hip and knee arthroplasty as compared to routine preoperative education.
Hypothesis: Preoperative anxiety related to hip and knee replacement surgeries can be reduced by patient exposure to a virtual hospital inpatient experience delivered by a series of YouTube videos.
Detailed description
As high patient anxiety prior to surgery has been linked to more severe and persistent pain after joint replacement surgery, the Orthopedic Surgery Department at Mayo Clinic in Florida created a playlist of 16 YouTube videos aimed at creating a virtual hospital experience for primary total hip and knee joint replacement patients. A pilot study was then performed to evaluate the potential impact of viewing this playlist on preoperative anxiety.
Methods: Each patient completed a Generalized Anxiety Disorder Score (GAD) assessment at the time of the routine preoperative clinic visit and were then randomized based on their gender, type of surgery, and initial GAD score to either the control group of standard education (education at face-to-face clinical visits as well as printed educational materials) or the treatment group of standard education plus access to the YouTube playlist. On the morning of the patient's surgery the same survey was repeated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YouTube Video Viewers | Experimental | Other: Viewing YouTube videosSubjects in this arm were randomized to viewing YouTube videos. |
| Standard Education | Active comparator | Other: Standard preoperative educationSubjects in this arm were randomized to standard preoperative education. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing primary total hip or total knee arthroplasty at Mayo Clinic in Florida
- Patients must be able to give consent to the study
- Patients must agree to watch the videos prior to scheduled surgery
- Patients must agree to complete the questionnaire in the office and again prior to surgery on the day of surgery
Key exclusion criteria (2 listed)
- No internet access at home
- Visual or auditory conditions which limit a patient's ability to view the You Tube videos at home
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 |
|---|---|---|
| Viewing YouTube videosThe on-line patient education program will highlight postoperative care. | Other | YouTube Video Viewers |
| Standard preoperative educationStandard preoperative education will be provided by the surgeon, physician extender and paramedical staff in the clinic. | Other | Standard Education |
Primary outcome
Change in Generalized Anxiety Disorder (GAD) Score
Time frame: Baseline, approximately 2-3 weeks
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 10 Sep 2015.
- Derived from this study: PubMed 27091674O'Connor MI, Brennan K, Kazmerchak S, Pratt J. YouTube Videos to Create a "Virtual Hospital Experience" for Hip and Knee Replacement Patients to Decrease Preoperative Anxiety: A Randomized Trial. Interact J Med Res. 2016 Apr 18;5(2):e10. doi: 10.2196/ijmr.4295.
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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.
Mary O'Connor, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Viewing YouTube videos and Standard preoperative education in people with Anxiety, run by Mayo Clinic.
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 4 inclusion and 2 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 10 Sep 2015. 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?
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?
Change in Generalized Anxiety Disorder (GAD) Score (time frame: Baseline, approximately 2-3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02546180, which also lists 1 linked publication.
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 10 Sep 2015.