NCT03677453

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

September 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

2.1 years

First QC Date

September 17, 2018

Last Update Submit

February 2, 2021

Conditions

Tonsillar HypertrophyAdenoid HypertrophyCryptorchidismHypospadiasHydrocele

Outcome Measures

Primary Outcomes (1)

  • 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).

    Immediately prior to discharge

Secondary Outcomes (1)

  • Anxiety level

    Baseline

Study Arms (2)

IPTP

ACTIVE COMPARATOR

Patients will have access to the web-based interactive teaching tool.

Other: Interactive Perioperative Teaching Platform

Non-IPTP

NO INTERVENTION

Patients will not have access to the web-based interactive teaching tool.

Interventions

Interactive Perioperative Teaching PlatformOTHER

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.

Also known as: IPTP
IPTP

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Patients will be excluded if they have previously undergone surgery or require a translator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

CryptorchidismHypospadiasTesticular Hydrocele

Condition Hierarchy (Ancestors)

Testicular DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrogenital AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsPenile Diseases

Study Design

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

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 19, 2018

Study Start

October 10, 2018

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

February 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)