Scoliosis Idiopathic AdolescentNCT03835390
SIMDiscovery: The Benefits of Utilizing a Simulation Preparation Program for Spinal Fusion Surgery
A study testing SIMDiscovery in people with Scoliosis Idiopathic Adolescent, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic Adolescent
- What is being tested?
- SIMDiscovery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2019to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- - Other significant chronic medical conditions (e.g., spina bifida, muscular dystrophy)
- Anterior surgical access
- ICU stay expected post-op
- Cognitive functioning level below 10yo
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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
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.
- Conditions
- Scoliosis Idiopathic Adolescent
- Being tested
- SIMDiscovery
- Keywords
- Anxiety, Preparedness, Spinal Fusion
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIMDiscoveryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: SIMDiscovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 1 month
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).
Measured: Baseline, 1 month
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.
Measured: Baseline, 1 month
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.
Measured: Baseline, 1 month
Secondary outcomes (1)
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
Measured: Baseline, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start22 Feb 2019
- Primary completion9 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis Idiopathic AdolescentStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Hedequist, Boston Children's Hospital
- Investigators
- Daniel Hedequist, MD, Principal investigator, Boston Children's HospitalLauren Potthoff, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835390
- Sponsor's protocol ID
- IRB-P00030717
- Status last verified
- Sep 2020
- First submitted
- 5 Feb 2019
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03835390
- Acronym / sponsor ID
- IRB-P00030717
- Conditions
- Scoliosis Idiopathic Adolescent
- Keywords
- Anxiety, Preparedness, Spinal Fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: SIMDiscoveryParticipants 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- - Other significant chronic medical conditions (e.g., spina bifida, muscular dystrophy)
- Anterior surgical access
- ICU stay expected post-op
- Cognitive functioning level below 10yo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIMDiscoveryThe 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. | Behavioural | Intervention |
Primary outcome
Change from Parent's and Adolescent's Baseline Anxiety at 1 month using the State/Trait Anxiety Inventory
Time frame: Baseline, 1 month
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
Time frame: Baseline, 1 month
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
Time frame: Baseline, 1 month
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
Time frame: Baseline, 1 month
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.
1 secondary outcome
Knowledge of Perioperative Procedures measured by Spinal Fusion Knowledge Assessment
Time frame: Baseline, 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Hedequist, MD principal investigator
Boston Children's Hospital
Lauren Potthoff, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIMDiscovery in people with Scoliosis Idiopathic Adolescent, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Parent's and Adolescent's Baseline Anxiety at 1 month using the State/Trait Anxiety Inventory (time frame: Baseline, 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.