NCT02517658

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 19, 2019

Completed
Last Updated

February 19, 2019

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

August 5, 2015

Results QC Date

September 28, 2017

Last Update Submit

February 12, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    approx. 1 - 2 hrs post-op

Study Arms (3)

Standard Discharge Teaching

ACTIVE COMPARATOR

Parents will receive standard discharge teaching from the nurse prior to discharge.

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.

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.

Other: VideoOther: Standard discharge teaching

Interventions

VideoOTHER

Watching a YouTube video containing post tonsillectomy discharge instructions.

Video w/ post exam after discharge teachingVideo w/ post exam immediately after video

Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge.

Standard Discharge TeachingVideo w/ post exam after discharge teaching

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parent or caregiver of any child having either adenotonsillectomy or tonsillectomy.

You may not qualify if:

  • Non-english speaking families that require an interpreter.
  • Any parent/family/caregiver that declines to be part of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Results Point of Contact

Title
Clinical Research Coordinator
Organization
Nationwide Children's Hospital

Study Officials

  • Sarah Khan, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 7, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 19, 2019

Results First Posted

February 19, 2019

Record last verified: 2018-08

Locations