Clinical trial NCT06427148: Feasibility and Acceptability of Biofeedback-based Virtual Reality Game for Children
Official title: Golden Breath: Feasibility and Acceptability of Biofeedback-based Virtual Reality Game for Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Population
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 15
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feedback was gathered from 10 pediatricians and nurses. Additionally, 5 inpatient children at Koç University Hospital provided their opinions on GoldenBreath, assessing ease of use, clarity, content appropriateness, sound volume, instruction clarity, game duration, and improvement suggestions. Based on feedback from 2 children suggesting more gold coins and longer game duration, options were added to adjust these elements in the game's menu.

Stage 2: Following expert and child evaluations, a preliminary trial was conducted with 13 children at Koç University Hospital's pediatric outpatient clinic. The researcher met with children and parents ten minutes before the procedure. Children tried the game, using VR headsets and earphones during the procedure while receiving routine care.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The biofeedback-assisted VR game "Golden Breath" that investigators presented in this study was designed to meet children's 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 children's overall experience during medical interventions.

Detailed description: Children's 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 children's health needs. VR, in particular, has gained popularity as a technological intervention, with numerous studies evaluating its effectiveness during children's 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 children's pain, fear, and anxiety levels.

In addition to VR, integrating biofeedback technologies into VR experiences has shown positive effects on children's 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.

Eligibility criteria: Inclusion Criteria:

* Patients aged 4-12
* Applied to Koç University Hospital Pediatrics Outpatient Clinic

Exclusion Criteria:

* Children with a pain score \<2 before the procedure
* Participants with previous experience with respiratory biofeedback in VR

Primary outcomes:
measure: Pain-Wong-Baker Pain Assessment Scale
timeFrame: immediately after the intervention
measure: Fear- Child Fear Scale
timeFrame: baseline and immediately after the intervention
measure: GoldenBreath Evaluation Form
timeFrame: During the development phase of the game
measure: Mobile Application Usability Scale
timeFrame: During the development phase of the game
Secondary outcomes:
Other outcomes:
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