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Preliminary findings showed no significant difference between virtual reality and distraction techniques.
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The purpose of this study is to demonstrate that the use of a virtual reality experience can decrease child and caregiver anxiety and pain for simple orthopaedic office procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Standard comfort given |
|
| Virtual Reality (VR) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Behavioral | This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Child Pain Score | Assessed by Wong-Baker Children's Faces Pain Scale: The scale shows a series of faces ranging from a happy face at 0 which represents "no hurt" to a crying face at 10 which represents "hurts worst." Based on the faces and descriptions, the patient chooses the face that best describes their level of pain. | Up to 24 hours following procedure |
| Child Anxiety (7 Years Old and Older) | Assessed by State-Trait Anxiety Inventory for Children (STAIC): 20 questions with 3 answer options for each question. Scores range from 20 to 60 with 60 being the higher (more or worse) anxiety on self-assessment. | Up to 24 hours following procedure |
| Child Anxiety (Younger Than 7 Years Old) | Assessed by Children's Fear Scale: The Children's Fear Scale (CFS) is used to measure the anxiety or fear level of the children. The one-item scale consists of a row of five sex neutral faces ranging from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. Thus, the scale is 1-5 with 1 being least fear and 5 being greatest fear and anxiety. | Up to 24 hours following procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Parental Anxiety | Assessed by State-Trait Anxiety Inventory (STAI): a 20 question inventory where each question is on a Likert scale 1-4. The total range of the inventory is 20-80 with higher scores indicating more anxiety (please note that some questions are reverse coded). | Up to 24 hours following procedure |
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Inclusion Criteria for pediatric patient:
Exclusion Criteria for pediatric patient:
There is no minimum or maximum age for the Caretakers/Parents.
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| Name | Affiliation | Role |
|---|---|---|
| Noelle Whyte, MD | University of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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Of 66 participants listed in the registration, three participants' data became unusable during the study, and therefore cannot be a part of the record. Parents of the children enrolled were asked to respond to a survey on a voluntary basis, but were not enrolled in the study as participants, did not contribute baseline data, and were not required to respond to the survey as part of their child's participation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Standard comfort given Control: This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention. |
| FG001 | Virtual Reality (VR) | Virtual Reality (VR): The child who is undergoing a procedure uses VR as a distraction during the intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Standard comfort given Control: This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention. |
| BG001 | Virtual Reality (VR) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Child Pain Score | Assessed by Wong-Baker Children's Faces Pain Scale: The scale shows a series of faces ranging from a happy face at 0 which represents "no hurt" to a crying face at 10 which represents "hurts worst." Based on the faces and descriptions, the patient chooses the face that best describes their level of pain. | Posted | Mean | Full Range | units on a scale | Up to 24 hours following procedure |
|
Up to 24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Standard comfort given Control: This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Noelle Whyte | University of Michigan | 734 936-5780 | whyteno@umich.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2023 | Jan 23, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Virtual Reality (VR) | Device | The child who is undergoing a procedure uses VR as a distraction during the intervention |
|
Virtual Reality (VR): The child who is undergoing a procedure uses VR as a distraction during the intervention
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Child Anxiety (7 Years Old and Older) | Assessed by State-Trait Anxiety Inventory for Children (STAIC): 20 questions with 3 answer options for each question. Scores range from 20 to 60 with 60 being the higher (more or worse) anxiety on self-assessment. | Note: This data is only for participants 7 and older, as also shown in baseline characteristics. | Posted | Mean | Full Range | units on a scale | Up to 24 hours following procedure |
|
|
|
| Primary | Child Anxiety (Younger Than 7 Years Old) | Assessed by Children's Fear Scale: The Children's Fear Scale (CFS) is used to measure the anxiety or fear level of the children. The one-item scale consists of a row of five sex neutral faces ranging from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. Thus, the scale is 1-5 with 1 being least fear and 5 being greatest fear and anxiety. | Note: This data is only for participants younger than 7 years old, as also shown in baseline characteristics. | Posted | Mean | Full Range | units on a scale | Up to 24 hours following procedure |
|
|
|
| Secondary | Parental Anxiety | Assessed by State-Trait Anxiety Inventory (STAI): a 20 question inventory where each question is on a Likert scale 1-4. The total range of the inventory is 20-80 with higher scores indicating more anxiety (please note that some questions are reverse coded). | Data was volunteered by 63 parents or caretakers of the participants. They were not consented separately from the children who were the focus of the study. | Posted | Mean | Full Range | score on a scale | Up to 24 hours following procedure |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Virtual Reality (VR) | Virtual Reality (VR): The child who is undergoing a procedure uses VR as a distraction during the intervention | 0 | 35 | 0 | 35 | 0 | 35 |
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