- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02517658
Adenotonsillectomy Postoperative Parental Teaching Tool
February 12, 2019 updated by: Sarah Khan
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parent or caregiver of any child having either adenotonsillectomy or tonsillectomy.
Exclusion Criteria:
- Non-english speaking families that require an interpreter.
- Any parent/family/caregiver that declines to be part of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard Discharge Teaching
Parents will receive standard discharge teaching from the nurse prior to discharge.
|
Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge.
|
|
Experimental: Video w/ post exam immediately after video
Parents will watch the video and then take the post test immediately after watching the video.
|
Watching a YouTube video containing post tonsillectomy discharge instructions.
|
|
Experimental: Video w/ post exam after discharge teaching
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.
|
Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge.
Watching a YouTube video containing post tonsillectomy discharge instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
approx. 1 - 2 hrs post-op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah Khan, MD, Nationwide Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
August 5, 2015
First Submitted That Met QC Criteria
August 6, 2015
First Posted (Estimate)
August 7, 2015
Study Record Updates
Last Update Posted (Actual)
February 19, 2019
Last Update Submitted That Met QC Criteria
February 12, 2019
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- IRB15-00063
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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