SIMDiscovery: The Benefits of Utilizing a Simulation Preparation Program for Spinal Fusion Surgery

NCT ID: NCT03835390

Last Updated: 2020-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-22

Study Completion Date

2019-10-01

Brief Summary

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This is a pilot study aiming to examine preliminary effectiveness of a preparation program which includes simulation (SIMDiscovery) in reducing anxiety and increasing feelings of preparedness among parents and their children who will undergo spinal fusion surgery. SIMDiscovery is an experiential learning preparation program which aims to educate children and families about different medical procedures through simulation play.

Detailed Description

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Conditions

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Scoliosis Idiopathic Adolescent

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Participants who agree to participate in the SIMDiscovery program will be asked if they would like to participate in the research. If they consent, they will fill out pre- and post-questionnaires concerning quality of life, anxiety levels concerning the surgery, and a knowledge assessment.

Group Type EXPERIMENTAL

SIMDiscovery

Intervention Type BEHAVIORAL

The SIMDiscovery program consists of nine stations that were designed to mirror the different stages of the perioperative process. The stations mirror the different stages of the surgical process and provide patients and their families with education regarding what they can anticipate during each aspect of the intervention.

Interventions

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SIMDiscovery

The SIMDiscovery program consists of nine stations that were designed to mirror the different stages of the perioperative process. The stations mirror the different stages of the surgical process and provide patients and their families with education regarding what they can anticipate during each aspect of the intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children and adolescents with adolescent idiopathic scoliosis and their parent(s)
* Spinal fusion surgery scheduled
* Developmental Age range (10+; no upper age range)
* Males and females of all races and ethnicities
* English-speaking families (although English need not be their primary language)
* Both patient and caregiver (when patient is under 18 years of age) are able to attend SIMDiscovery program

Exclusion Criteria

* \- Other significant chronic medical conditions (e.g., spina bifida, muscular dystrophy)
* Anterior surgical access
* ICU stay expected post-op
* Cognitive functioning level below 10yo
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Daniel Hedequist

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Hedequist, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Lauren Potthoff, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-P00030717

Identifier Type: -

Identifier Source: org_study_id

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