Anxiety, Pain
Conditions
Keywords
Virtual reality
Brief summary
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.
Interventions
BEHAVIORALControl
This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention.
DEVICEVirtual Reality (VR)
The child who is undergoing a procedure uses VR as a distraction during the intervention
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for pediatric patient: * Undergoing cast removal, pin removal, or suture removal in study affiliated clinic * Less than 17 years old
Exclusion criteria
for pediatric patient: * History of seizures * Pregnant, have preexisting binocular vision abnormalities or psychiatric disorders, or suffer from a heart condition or other serious medical condition * Patients can't have implanted medical devices including cardiac pacemakers, hearing aids and defibrillators There is no minimum or maximum age for the Caretakers/Parents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Pain Score | Up to 24 hours following procedure | 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. |
| Child Anxiety (7 Years Old and Older) | Up to 24 hours following procedure | 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. |
| Child Anxiety (Younger Than 7 Years Old) | Up to 24 hours following procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Anxiety | Up to 24 hours following procedure | 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). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| Virtual Reality (VR) Virtual Reality (VR): The child who is undergoing a procedure uses VR as a distraction during the intervention | 35 |
| Total | 63 |
Baseline characteristics
| Characteristic | Control | Virtual Reality (VR) | Total |
|---|---|---|---|
| Age, Customized Age <7 | 8 Participants | 7 Participants | 15 Participants |
| Age, Customized Age >=7 | 20 Participants | 28 Participants | 48 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 28 participants | 35 participants | 63 participants |
| Sex: Female, Male Female | 14 Participants | 16 Participants | 30 Participants |
| Sex: Female, Male Male | 14 Participants | 19 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 35 |
| other Total, other adverse events | 0 / 28 | 0 / 35 |
| serious Total, serious adverse events | 0 / 28 | 0 / 35 |
Outcome results
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.
Time frame: Up to 24 hours following procedure
Population: Note: This data is only for participants 7 and older, as also shown in baseline characteristics.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control | Child Anxiety (7 Years Old and Older) | Pre-Intervention | 28.55 units on a scale |
| Control | Child Anxiety (7 Years Old and Older) | Post-Intervention | 26.35 units on a scale |
| Virtual Reality (VR) | Child Anxiety (7 Years Old and Older) | Pre-Intervention | 32.88 units on a scale |
| Virtual Reality (VR) | Child Anxiety (7 Years Old and Older) | Post-Intervention | 27.96 units on a scale |
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.
Time frame: Up to 24 hours following procedure
Population: Note: This data is only for participants younger than 7 years old, as also shown in baseline characteristics.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control | Child Anxiety (Younger Than 7 Years Old) | Pre-Intervention | 1.375 units on a scale |
| Control | Child Anxiety (Younger Than 7 Years Old) | Post-Intervention | .75 units on a scale |
| Virtual Reality (VR) | Child Anxiety (Younger Than 7 Years Old) | Pre-Intervention | 1.5 units on a scale |
| Virtual Reality (VR) | Child Anxiety (Younger Than 7 Years Old) | Post-Intervention | 0.875 units on a scale |
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.
Time frame: Up to 24 hours following procedure
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control | Child Pain Score | Pre-Intervention | .5 units on a scale |
| Control | Child Pain Score | Post-Intervention | 1.07 units on a scale |
| Virtual Reality (VR) | Child Pain Score | Pre-Intervention | 1.2 units on a scale |
| Virtual Reality (VR) | Child Pain Score | Post-Intervention | .97 units on a scale |
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).
Time frame: Up to 24 hours following procedure
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Parental Anxiety | 46.61 score on a scale |
| Virtual Reality (VR) | Parental Anxiety | 46.91 score on a scale |