Back to resultsInteractive Perioperative Teaching Platform (IPTP)
Primary Purpose
Tonsillar Hypertrophy, Adenoid Hypertrophy, Cryptorchidism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interactive Perioperative Teaching Platform
Sponsored by
About this trial
This is an interventional other trial for Tonsillar Hypertrophy
Eligibility Criteria
Inclusion Criteria:
- Children aged 0-18 years
- Undergoing adenotonsillectomy or orchiopexy, hydrocele or hypospadias repair
- Only patients booked for ambulatory surgery in the main operating room (OR)
Exclusion Criteria:
- Patients will be excluded if they have previously undergone surgery or require a translator
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
IPTP
Non-IPTP
Arm Description
Patients will have access to the web-based interactive teaching tool.
Patients will not have access to the web-based interactive teaching tool.
Outcomes
Primary Outcome Measures
Patient family satisfaction
Family satisfaction will be assessed by a member of the research team using an adaptation of the English version of the Leiden Perioperative Patient Satisfaction questionnaire (LPPSq) recommended for research on satisfaction with surgeries involving anesthesia. The English version assesses 4 domains of satisfaction: information provision, professional competence, patient-staff relationship, and service with a total of 24 questions on these topics. It is scored on a 1-5 Likert scale (from completely dissatisfied to completely satisfied).
Secondary Outcome Measures
Anxiety level
Anxiety will be measured using the short-form State-Trait Anxiety Inventory 10 with scores ranging from 6-24 (least to most anxious).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03677453
Brief Title
Interactive Perioperative Teaching Platform (IPTP)
Official Title
Interactive Perioperative Teaching Platform (IPTP)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vidya Raman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed study will assess whether an interactive perioperative teaching platform (IPTP) provided to families of patients undergoing ambulatory pediatric surgery will reduce families' anxiety, and improve satisfaction and understanding, relative to current practice. The IPTP will educate patient families on the continuum of their child's surgical experience, from arriving at the hospital through registration, the operating room (OR), and the hospital floor. An active video format will be used to provide instructions for navigating the hospital; describe induction of anesthesia and the surgical procedure; and provide post-surgery and post-discharge instructions for pain management. A comparison cohort of patients undergoing surgery without access to the IPTP will be recruited to assess the benefits of the IPTP for improving metrics of family satisfaction, preoperative anxiety, and postoperative understanding of discharge instructions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillar Hypertrophy, Adenoid Hypertrophy, Cryptorchidism, Hypospadias, Hydrocele
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IPTP
Arm Type
Active Comparator
Arm Description
Patients will have access to the web-based interactive teaching tool.
Arm Title
Non-IPTP
Arm Type
No Intervention
Arm Description
Patients will not have access to the web-based interactive teaching tool.
Intervention Type
Other
Intervention Name(s)
Interactive Perioperative Teaching Platform
Other Intervention Name(s)
IPTP
Intervention Description
An active video format will be used to provide instructions for navigating the hospital; describe induction of anesthesia and the surgical procedure; and provide post-surgery and post-discharge instructions for pain management.
Primary Outcome Measure Information:
Title
Patient family satisfaction
Description
Family satisfaction will be assessed by a member of the research team using an adaptation of the English version of the Leiden Perioperative Patient Satisfaction questionnaire (LPPSq) recommended for research on satisfaction with surgeries involving anesthesia. The English version assesses 4 domains of satisfaction: information provision, professional competence, patient-staff relationship, and service with a total of 24 questions on these topics. It is scored on a 1-5 Likert scale (from completely dissatisfied to completely satisfied).
Time Frame
Immediately prior to discharge
Secondary Outcome Measure Information:
Title
Anxiety level
Description
Anxiety will be measured using the short-form State-Trait Anxiety Inventory 10 with scores ranging from 6-24 (least to most anxious).
Time Frame
Baseline
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 0-18 years
Undergoing adenotonsillectomy or orchiopexy, hydrocele or hypospadias repair
Only patients booked for ambulatory surgery in the main operating room (OR)
Exclusion Criteria:
Patients will be excluded if they have previously undergone surgery or require a translator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interactive Perioperative Teaching Platform (IPTP)
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