Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427148
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-15
Brief Title:
Feasibility and Acceptability of Biofeedback-based Virtual Reality Game for Children
Sponsor:
Koç University
Organization:
Koç University
Study Overview
Official Title:
Golden Breath Feasibility and Acceptability of Biofeedback-based Virtual Reality Game for Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
The biofeedback-assisted VR game Golden Breath that investigators presented in this study was designed to meet childrens healthcare needs quickly and efficiently while reducing pain and fear during medical procedures in the pediatric population Golden Breath utilizes biofeedback techniques in a VR environment to ensure the active participation of children By encouraging the practice of breathing techniques throughout the game the game aims to reduce negative emotions associated with medical procedures Through this innovative approach investigators aim to provide new evidence supporting the effectiveness of VR and biofeedback interventions in pediatric clinical settings and ultimately improve childrens overall experience during medical interventions
Detailed Description:
Childrens increasing interest in phones tablets and computer games has led to the integration of technological interventions in pediatric healthcare services Innovations such as telemedicine telerehabilitation mobile health applications virtual reality VR and mobile games provide easy and accessible ways to meet childrens health needs VR in particular has gained popularity as a technological intervention with numerous studies evaluating its effectiveness during childrens medical procedures Research has shown that VR use during procedures like port catheter needle insertion significantly reduces pain and fear Similarly VR during venipuncture has been found to positively affect childrens pain fear and anxiety levels
In addition to VR integrating biofeedback technologies into VR experiences has shown positive effects on childrens psychosocial outcomes Studies on biofeedback-based VR games highlight their anxiety-reducing effects For instance a biofeedback-based VR game was found to reduce anxiety in children and a neurofeedback video game MindLight significantly lowered anxiety levels Another study found that a biofeedback-based video game during venipuncture helped distract children from the painful procedure reducing their pain levels
Combining VR and biofeedback technologies is believed to enhance intervention outcomes Biofeedback alone may provide overly abstract or complex visual feedback while the increased interactivity of VR boosts user engagement Effective attention capture and active participation are crucial for developing skills and ensuring consistency through these technologies Biofeedback in VR helps users control their physiological parameters which is particularly beneficial for children who can be difficult to engage effectively These technologies can serve as effective methods for distracting children during medical procedures
Pediatric medical procedures often cause pain fear and anxiety which can persist long after the procedure and complicate treatment adherence Therefore controlling pain fear and anxiety is extremely important Recent analyses highlight the potential of VR and biofeedback-assisted interventions to alleviate emotional distress in children Moreover the rise in digital engagement encourages healthcare professionals to develop new approaches to support child health in clinical settings
In addition to VR integrating biofeedback technologies into VR experiences has shown positive effects on childrens psychosocial outcomes Studies on biofeedback-based VR games highlight their anxiety-reducing effects For instance a biofeedback-based VR game was found to reduce anxiety in children and a neurofeedback video game MindLight significantly lowered anxiety levels Another study found that a biofeedback-based video game during venipuncture helped distract children from the painful procedure reducing their pain levels
Combining VR and biofeedback technologies is believed to enhance intervention outcomes Biofeedback alone may provide overly abstract or complex visual feedback while the increased interactivity of VR boosts user engagement Effective attention capture and active participation are crucial for developing skills and ensuring consistency through these technologies Biofeedback in VR helps users control their physiological parameters which is particularly beneficial for children who can be difficult to engage effectively These technologies can serve as effective methods for distracting children during medical procedures
Pediatric medical procedures often cause pain fear and anxiety which can persist long after the procedure and complicate treatment adherence Therefore controlling pain fear and anxiety is extremely important Recent analyses highlight the potential of VR and biofeedback-assisted interventions to alleviate emotional distress in children Moreover the rise in digital engagement encourages healthcare professionals to develop new approaches to support child health in clinical settings
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