Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04892160
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2021-05-07
Brief Title:
Distracting Through Procedural Pain and Distress
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Comparison of Guided Imagery and Virtual Reality VR Technology on Patient and Parent Coping and Resource Utilization During Unsedated Procedures
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Children with acute and chronic illness undergo frequent painful and distressing procedures This randomized control trial was used to evaluate the effectiveness of guided imagery GI vs virtual reality VR on the procedural pain and state anxiety of children and young adults undergoing un-sedated procedures We explored the role of trait anxiety and pain catastrophizing in intervention response
Detailed Description:
Treatment for pediatric cancer and blood disorders can range from several months to several years During the course of treatment children often undergo several painful andor frightening procedures Common unsedated procedures include needle access of an implanted central venous port ie port access prior to receiving chemotherapy intravenous needle sticks to provide chronic transfusion therapy or treatment for iron overload in patients with sickle cell disease and weekly changing of the bandage dressing around a peripherally inserted central catheter PICC These procedures are often distressing to a pediatric patient As a result there is an emphasis on the use of non-pharmacologic interventions to manage symptoms of patient pain and anxiety for procedures that do not warrant pharmacologic intervention There is also ample evidence to suggest that parental coping is associated with child distress which highlights the need for interventions that have the potential to decrease parental as well as patient distress Interventions that are cost-effective and sustainable are most appealing in the current healthcare environment
Non-immersive distraction such as guided imagery is widely regarded as useful in decreasing pain and anxiety during procedures Guided imagery is a cognitive strategy that typically involves a staff member describing in detail a situation that is incompatible with the experience of pain and is meant to invoke feelings of calm It is a commonly used intervention to address procedural distress and aside from staff time is free of cost However that the more distracting the stimuli the greater the expenditure of cognitive energy and the greater reduction in ones capacity to process pain and feel distressed This leads one to question whether VR an immersive interactive technology that can realistically project three-dimensional images may be more effective than a non-immersive distraction in managing procedure-related pain and distress VR has been used to assist with procedural distress in several contexts over the past 15 years including pediatric pain burn care dental procedures and port access Reviews of VR usage have been generally positive with most studies suggesting that VR is a feasible and efficacious method of distraction that can reduce patient-reported and objective physiological measures of pain and distress Effect sizes in the medium to the large range have been found when comparing VR to standard of care and non-immersive distraction eg videogames have found that subjects using VR distraction for pain showed more improvement than approximately 83 of control subjects Other sources have highlighted positive patient satisfaction and a low incidence of negative side effects eg motion sickness when using VR The cost of VR equipment has decreased over the years although VR headsets still average 300-500 with additional cost for game controllers and smartphonesgame systems For use within a hospital the further cost would need to be incurred to reduce the risk of infection for equipment that is shared
Using a comparative effectiveness model this project will compare a low-cost but widely accepted non-immersive distraction intervention guided imagery to a higher cost but very promising immersive intervention VR in managing patient pain and anxiety as well as parent distress To our knowledge this is the first time these two interventions will be directly compared It is also the first time that parental distress will be measured as an outcome of a VR intervention Hospital resource utilization staff time facility usage will be evaluated as an additional costbenefit aspect of the intervention
Non-immersive distraction such as guided imagery is widely regarded as useful in decreasing pain and anxiety during procedures Guided imagery is a cognitive strategy that typically involves a staff member describing in detail a situation that is incompatible with the experience of pain and is meant to invoke feelings of calm It is a commonly used intervention to address procedural distress and aside from staff time is free of cost However that the more distracting the stimuli the greater the expenditure of cognitive energy and the greater reduction in ones capacity to process pain and feel distressed This leads one to question whether VR an immersive interactive technology that can realistically project three-dimensional images may be more effective than a non-immersive distraction in managing procedure-related pain and distress VR has been used to assist with procedural distress in several contexts over the past 15 years including pediatric pain burn care dental procedures and port access Reviews of VR usage have been generally positive with most studies suggesting that VR is a feasible and efficacious method of distraction that can reduce patient-reported and objective physiological measures of pain and distress Effect sizes in the medium to the large range have been found when comparing VR to standard of care and non-immersive distraction eg videogames have found that subjects using VR distraction for pain showed more improvement than approximately 83 of control subjects Other sources have highlighted positive patient satisfaction and a low incidence of negative side effects eg motion sickness when using VR The cost of VR equipment has decreased over the years although VR headsets still average 300-500 with additional cost for game controllers and smartphonesgame systems For use within a hospital the further cost would need to be incurred to reduce the risk of infection for equipment that is shared
Using a comparative effectiveness model this project will compare a low-cost but widely accepted non-immersive distraction intervention guided imagery to a higher cost but very promising immersive intervention VR in managing patient pain and anxiety as well as parent distress To our knowledge this is the first time these two interventions will be directly compared It is also the first time that parental distress will be measured as an outcome of a VR intervention Hospital resource utilization staff time facility usage will be evaluated as an additional costbenefit aspect of the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None