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

Primary Purpose

Scoliosis Idiopathic Adolescent

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SIMDiscovery
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis Idiopathic Adolescent focused on measuring Anxiety, Preparedness, Spinal Fusion

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from Parent's and Adolescent's Baseline Anxiety at 1 month using the State/Trait Anxiety Inventory
Parent and adolescent anxiety will be measured at baseline utilizing the State/Trait Anxiety Inventory (STAI) (Spielberger et al., 1983). The STAI consists of 40 items total-20 items assessing trait anxiety (general proneness to anxious behavior) and 20 items assessing state anxiety (a current emotional state). All items are scored using a four-point scale (e.g., ranging from "Almost Never" to "Almost Always"). Scores can range from 20 to 80 with higher scores indicating greater anxiety. This measure has been validated for use with individuals ages 15 and above (Julian, 2011). If a patient is 15 years of age or above, they will complete the STAI, rather than the STAIC (see below).
Change from Child's Baseline Anxiety at 1 month using the State/Trait Anxiety Inventory for Children
Child anxiety will be assessed utilizing the State/Trait Anxiety Inventory for Children (STAIC) (Spielberger & Edwards, 1973). Similar to the STAI, the STAIC consists of 20 items assessing state anxiety and 20 items assessing trait anxiety. Items are scored using a four-point scale and higher scores indicate greater anxiety. The STAIC has been validated for use with children up to age 15 years (Spielberger & Edwards, 1973).
Change from Parent's Baseline Feelings of Preparedness at 1 month using Caregiver Preparedness Scale
Parent preparedness will be measured using the Caregiver Preparedness Scale (CPS) (Archbold, et al., 1990). This scale has been validated for use with adult caregivers (Petruzzo et al., 2017; Pucciarelli et al., 2014). The CPS includes eight items assessing caregiver preparedness to care for a patient's physical and emotional needs, setting up services, coping with the stress of caregiving, making caregiving activities pleasant for the caregiver and patient, responding and managing emergencies, obtaining assistance from the health care system, and overall preparedness. Each item is rated from 0 (not at all prepared) to 4 (Very well prepared). Items are summed for a total score that ranges from 0 to 32, with higher scores indicating feeling better prepared for the caregiving role.
Change from Child's Baseline Feelings of Preparedness at 1 month using a modified Caregiver Preparedness Scale
In order to examine themes similar to parent preparedness but from the patient's perspective, we will administer a measure similar to the CPS (above) for children and adolescent patients. This measure has not been validated; rather, based on the validity of the CPS used to assess parent preparedness, we modified the measure to assess patients' perception of their ability to care for or advocate for themselves regarding their physical and emotional needs prior to the surgery. (Archbold, et al., 1990). All patients will complete this measure. This measure consists of six questions and similar to the CPS, each item is rated from 0 (not at all prepared) to 4 (Very well prepared). Items are summed for a total score that ranges from 0 to 24, with higher scores indicating more feelings of preparedness for the surgery.

Secondary Outcome Measures

Knowledge of Perioperative Procedures measured by Spinal Fusion Knowledge Assessment
Facts that patients learn through the preoperative appointment and the SIMDiscovery program measured by the Spine Fusion Knowledge Assessment developed by our team

Full Information

First Posted
February 5, 2019
Last Updated
September 3, 2020
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03835390
Brief Title
SIMDiscovery: The Benefits of Utilizing a Simulation Preparation Program for Spinal Fusion Surgery
Official Title
SIMDiscovery: The Benefits of Utilizing a Preparation Program With Simulation in Reducing Anxiety and Increasing Preparedness Among Parents and Their Children Undergoing Spinal Fusion Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
September 9, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic Adolescent
Keywords
Anxiety, Preparedness, Spinal Fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SIMDiscovery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Parent's and Adolescent's Baseline Anxiety at 1 month using the State/Trait Anxiety Inventory
Description
Parent and adolescent anxiety will be measured at baseline utilizing the State/Trait Anxiety Inventory (STAI) (Spielberger et al., 1983). The STAI consists of 40 items total-20 items assessing trait anxiety (general proneness to anxious behavior) and 20 items assessing state anxiety (a current emotional state). All items are scored using a four-point scale (e.g., ranging from "Almost Never" to "Almost Always"). Scores can range from 20 to 80 with higher scores indicating greater anxiety. This measure has been validated for use with individuals ages 15 and above (Julian, 2011). If a patient is 15 years of age or above, they will complete the STAI, rather than the STAIC (see below).
Time Frame
Baseline, 1 month
Title
Change from Child's Baseline Anxiety at 1 month using the State/Trait Anxiety Inventory for Children
Description
Child anxiety will be assessed utilizing the State/Trait Anxiety Inventory for Children (STAIC) (Spielberger & Edwards, 1973). Similar to the STAI, the STAIC consists of 20 items assessing state anxiety and 20 items assessing trait anxiety. Items are scored using a four-point scale and higher scores indicate greater anxiety. The STAIC has been validated for use with children up to age 15 years (Spielberger & Edwards, 1973).
Time Frame
Baseline, 1 month
Title
Change from Parent's Baseline Feelings of Preparedness at 1 month using Caregiver Preparedness Scale
Description
Parent preparedness will be measured using the Caregiver Preparedness Scale (CPS) (Archbold, et al., 1990). This scale has been validated for use with adult caregivers (Petruzzo et al., 2017; Pucciarelli et al., 2014). The CPS includes eight items assessing caregiver preparedness to care for a patient's physical and emotional needs, setting up services, coping with the stress of caregiving, making caregiving activities pleasant for the caregiver and patient, responding and managing emergencies, obtaining assistance from the health care system, and overall preparedness. Each item is rated from 0 (not at all prepared) to 4 (Very well prepared). Items are summed for a total score that ranges from 0 to 32, with higher scores indicating feeling better prepared for the caregiving role.
Time Frame
Baseline, 1 month
Title
Change from Child's Baseline Feelings of Preparedness at 1 month using a modified Caregiver Preparedness Scale
Description
In order to examine themes similar to parent preparedness but from the patient's perspective, we will administer a measure similar to the CPS (above) for children and adolescent patients. This measure has not been validated; rather, based on the validity of the CPS used to assess parent preparedness, we modified the measure to assess patients' perception of their ability to care for or advocate for themselves regarding their physical and emotional needs prior to the surgery. (Archbold, et al., 1990). All patients will complete this measure. This measure consists of six questions and similar to the CPS, each item is rated from 0 (not at all prepared) to 4 (Very well prepared). Items are summed for a total score that ranges from 0 to 24, with higher scores indicating more feelings of preparedness for the surgery.
Time Frame
Baseline, 1 month
Secondary Outcome Measure Information:
Title
Knowledge of Perioperative Procedures measured by Spinal Fusion Knowledge Assessment
Description
Facts that patients learn through the preoperative appointment and the SIMDiscovery program measured by the Spine Fusion Knowledge Assessment developed by our team
Time Frame
Baseline, 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Hedequist, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lauren Potthoff, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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