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Interactive Perioperative Teaching Platform (IPTP)

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ClinicalTrials.gov Identifier: NCT03677453
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Vidya Raman, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Tonsillar Hypertrophy Adenoid Hypertrophy Cryptorchidism Hypospadias Hydrocele Other: Interactive Perioperative Teaching Platform Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Interactive Perioperative Teaching Platform (IPTP)
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: IPTP
Patients will have access to the web-based interactive teaching tool.
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.
Other Name: IPTP

No Intervention: Non-IPTP
Patients will not have access to the web-based interactive teaching tool.



Primary Outcome Measures :
  1. Patient family satisfaction [ Time Frame: Immediately prior to discharge ]
    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 :
  1. Anxiety level [ Time Frame: Baseline ]
    Anxiety will be measured using the short-form State-Trait Anxiety Inventory 10 with scores ranging from 6-24 (least to most anxious).



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677453


Contacts
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Contact: Julie Rice-Weimer, RN 6143553142 julie.rice-weimer@nationwidechildrens.org

Locations
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United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Julie Rice-Weimer, RN    614-355-3142    julie.rice-weimer@nationwidechildrens.org   
Sponsors and Collaborators
Vidya Raman

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Responsible Party: Vidya Raman, Clinical Associate Professor of Anesthesiology, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03677453     History of Changes
Other Study ID Numbers: IRB17-01340
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypospadias
Cryptorchidism
Hypertrophy
Pathological Conditions, Anatomical
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Testicular Diseases
Gonadal Disorders
Endocrine System Diseases