Anxiety, Pain, Pain, Postoperative
Conditions
Keywords
Virtual Reality, Meditation, Mindfulness Meditation, Guided Mindfulness Meditation, Anxiety, Pain, Postoperative pain
Brief summary
This study aims to investigate the use of virtual reality guided mindfulness meditation to reduce the pre and post-operative anxiety and pain of pediatric surgical patients.
Detailed description
Pre-procedural anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, agitation, sleep disturbances, and negative behavioral changes. Post-procedural pain has been shown to negatively impact future interactions with healthcare personnel. The purpose of this study is to determine the feasibility of using guided mindfulness meditation through a non-invasive device (virtual reality headset) to manage pre-procedure anxiety and post-procedure anxiety and pain.
Interventions
DEVICEVirtual Reality Headset Given
Samsung Gear VR Headset with guided mindfulness meditation app
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Prospective observational study
Eligibility
Sex/Gender
ALL
Age
5 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Have parental consent if under 18 or 18 and older but unable to provide own consent * Can comprehend instructions in English language * Is undergoing surgical procedure requiring general anesthesia at Lucile Packard Children's Hospital * Children that are normally healthy (ASA I) or have a mild systemic disease (ASA II, III)
Exclusion criteria
* Children with significant cognitive impairment or developmental delays per parental report or H&P * Children with ASA IV (severe systemic disease that is a constant threat to life) or ASA V (unstable patients not expected to survive \>24hours or without operation) * Children currently taking psychotropic mediations will be excluded from this study due to the affect emotion modulation * Children with history of seizures related to photosensitivity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Children's Fear Scale | Before and after every use of the app (from date of enrollment to surgical procedure, up to 8 weeks. If patient has not undergone surgical procedure by 8 weeks, participation in study will be concluded and subject censored during data analysis) | The Children's Fear Scale (McMurty et al., 2011) is a self-report scale that uses cartoon depictions of faces to quantify on a 0-4 scale how scared a child is at the given moment. |
| Change in Faces Pain Scale | Before and after every use of the app (from date of enrollment to surgical procedure, up to 8 weeks. If patient has not undergone surgical procedure by 8 weeks, participation in study will be concluded and subject censored during data analysis) | The Faces Pain Scale (Hicks et al., 2001) is a self-report scale that uses cartoon depictions of faces to quantify on a 0-10 scale how much pain a child is experiencing at the given moment. |
| Change in Anxiety Scale | Before and after every use of the app (from date of enrollment to surgical procedure, up to 8 weeks. If patient has not undergone surgical procedure by 8 weeks, participation in study will be concluded and subject censored during data analysis) | A self-report question on a 1-5 scale will be asked to assess how much anxiety a child is experiencing at the given moment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient and Parent Satisfaction Surveys | Satisfaction surveys will be administered at the time of study completion (when the patient has completed his/her surgical procedure and is ready for hospital discharge/or 30 days post-procedure, whichever occurs first) | Parents, and patients will be given self-report survey questions asking about their satisfaction with the technology, the patients' immersion with the technology, and desire for use in future procedures. Questions will be answered on a 1-5 scale . |
| Clinician Satisfaction Surveys | Satisfaction survey will be administered to physicians within 48 hours of procedure completion. Physicians may return surveys up to one month post-procedure. | Surgeons and anesthesiologists will be given self-report survey questions asking about their satisfaction with the technology, the patients' immersion with the technology, and desire for use in future procedures. Questions will be answered on a 1-5 scale . |
Countries
United States
Outcome results
None listed