Anxiety, Pain, Pain, Postoperative
Conditions
Brief summary
To determine the feasibility and acceptability of using immersive virtual reality technologies to impact clinical outcomes (e.g., pain and anxiety) and medication utilization (e.g., narcotics) in pediatric patients with acute and chronic pain.
Interventions
OTHERVR - Distraction
Participants will be instructed to use any application.
OTHERVR - Biofeedback
Participants will be instructed to use the Mindful Aurora application.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Ages 7to 21 years * Able to read, understand, and speak English * Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service (acute postoperative pain cohort); patients presenting in Same Day Surgery for peripheral IV placement or patients in the CBDI clinic presenting for peripheral IV placement or Port accessing (vascular access cohort); or patients admitted to CCHMC on the Medical Pain Service (chronic pain cohort), or sickle cell patients not on the MPS list. * Patients who have undergone bone marrow transplantation or receiving chemotherapy experiencing pain from mucositis
Exclusion criteria
* Outside the age range (\< 7 or \> 21 years) * History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting) * History of vertigo, dizziness, and/or seizure disorder * Conditions that would preclude the application of the VR glasses, such as surgeries of the head and neck
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of VR-Distraction on anxiety | Immediately after 10 minute VR session. | Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety |
| Effect of VR-Biofeedback on anxiety | Before 10 minute VR session. | Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety |
| Effect of VR-Biofeedback on pain | Before 10 minute VR session | Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain |
| Effect of VR-distraction on anxiety | Before 10 minute VR session. | Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety |
| Effect of VR-Distraction on pain | Before 10 minute VR session. | Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Role of pain catastrophizing | One time prior to study visit | Participants will complete a questionnaire regarding pain |
| Role of anxiety on changes in pain | One time prior to study visit | Participants will complete a questionnaire regarding anxiety |
Countries
United States
Outcome results
None listed