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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03677453
Other study ID # IRB17-01340
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2018
Est. completion date November 30, 2020

Study information

Verified date February 2021
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 151
Est. completion date November 30, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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

Study Design


Intervention

Other:
Interactive Perioperative Teaching Platform
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.

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Vidya Raman

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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). Baseline
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