TonsillectomyNCT02517658
Adenotonsillectomy Postoperative Parental Teaching Tool
A study testing Video and Standard discharge teaching in people with Tonsillectomy, run by Sarah Khan at 1 site in United States.
Trial summary
The study will involve parents filling out a survey before \& after watching a teaching tool video (https://www.youtube.com/watch?v=rIH63jqvlio) in addition to standard post-op teaching. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- Video and Standard discharge teaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parent or caregiver of any child having either adenotonsillectomy or tonsillectomy.
Who cannot join
- Non-english speaking families that require an interpreter.
- Any parent/family/caregiver that declines to be part of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
The study will involve parents filling out a survey before \& after watching a teaching tool video (https://www.youtube.com/watch?v=rIH63jqvlio) in addition to standard post-op teaching. The parents randomized to the video arms will watch the video while their child is in the OR and then either take the post survey immediately after or wait to take the survey until just prior to discharge. Parents not in the video arms of the study will also be asked to complete a survey pre and post standard pain management teaching.
- Conditions
- Tonsillectomy
- Being tested
- Video, Standard discharge teaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoOther
Watching a YouTube video containing post tonsillectomy discharge instructions.
Standard discharge teachingOther
Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge.
| Study group | Role | What they receive |
|---|---|---|
| Standard Discharge Teaching | Active comparator | Parents will receive standard discharge teaching from the nurse prior to discharge. Receives: Other: Standard discharge teaching |
| Video w/ post exam immediately after video | Experimental | Parents will watch the video and then take the post test immediately after watching the video. Receives: Other: Video |
| Video w/ post exam after discharge teaching | Experimental | Parents will watch the video but wait to take the post exam until after the discharge instructions are given by the nurse prior to discharge. Receives: Other: Video; Other: Standard discharge teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Answers to Pre & Post Teaching Questionnaires
Assessing the difference in how parents answered the questionnaire before receiving any discharge instructions and the questionnaire after watching the video or receiving standard discharge instructions by the nurse. Parents completed pre-instruction and post-instruction assessments of their knowledge of post-operative pain management, with responses scored on a 0-8 scale by assigning 1 point to each correct response out of 8 multiple-choice questions. Higher difference score means that the parents answered more questions correctly after the teaching/video.
Measured: approx. 1 - 2 hrs post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TonsillectomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Khan, Nationwide Children's Hospital
- Investigators
- Sarah Khan, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517658
- Sponsor's protocol ID
- IRB15-00063
- Status last verified
- Aug 2018
- First submitted
- 5 Aug 2015
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenotonsillectomy Postoperative Parental Teaching Tool
- ClinicalTrials.gov ID
- NCT02517658
- Acronym / sponsor ID
- IRB15-00063
- Conditions
- Tonsillectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Sarah KhanUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Posted 19 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will involve parents filling out a survey before \& after watching a teaching tool video (https://www.youtube.com/watch?v=rIH63jqvlio) in addition to standard post-op teaching. The parents randomized to the video arms will watch the video while their child is in the OR and then either take the post survey immediately after or wait to take the survey until just prior to discharge. Parents not in the video arms of the study will also be asked to complete a survey pre and post standard pain management teaching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Discharge Teaching | Active comparator | Other: Standard discharge teachingParents will receive standard discharge teaching from the nurse prior to discharge. |
| Video w/ post exam immediately after video | Experimental | Other: VideoParents will watch the video and then take the post test immediately after watching the video. |
| Video w/ post exam after discharge teaching | Experimental | Other: Video, Other: Standard discharge teachingParents will watch the video but wait to take the post exam until after the discharge instructions are given by the nurse prior to discharge. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parent or caregiver of any child having either adenotonsillectomy or tonsillectomy.
Key exclusion criteria (2 listed)
- Non-english speaking families that require an interpreter.
- Any parent/family/caregiver that declines to be part of the study.
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 |
|---|---|---|
| VideoWatching a YouTube video containing post tonsillectomy discharge instructions. | Other | Video w/ post exam after discharge teaching, Video w/ post exam immediately after video |
| Standard discharge teachingReceiving standard post tonsillectomy discharge instructions from the nurse prior to discharge. | Other | Standard Discharge Teaching, Video w/ post exam after discharge teaching |
Primary outcome
Difference in Answers to Pre & Post Teaching Questionnaires
Time frame: approx. 1 - 2 hrs post-op
Assessing the difference in how parents answered the questionnaire before receiving any discharge instructions and the questionnaire after watching the video or receiving standard discharge instructions by the nurse. Parents completed pre-instruction and post-instruction assessments of their knowledge of post-operative pain management, with responses scored on a 0-8 scale by assigning 1 point to each correct response out of 8 multiple-choice questions. Higher difference score means that the parents answered more questions correctly after the teaching/video.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sarah Khan, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video and Standard discharge teaching in people with Tonsillectomy, run by Sarah Khan 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 1 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 19 Feb 2019. 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. 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?
Yes. Results are posted in the registry (first posted 19 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Answers to Pre & Post Teaching Questionnaires (time frame: approx. 1 - 2 hrs post-op). 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 19 Feb 2019.