Feasibility and Acceptability of Biofeedback-based Virtual Reality Game for Children

NCT ID: NCT06427148

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-20
• Study Completion Date: 2024-05-31

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.

Conditions

Pediatric Population

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

To evaluate the feasibility and safety of the GoldenBreath before and after the procedure, the researchers asked the children to report their fears about the procedure. In addition, the children were asked to indicate the pain level they experienced, especially during the needle procedure. Possible missing data, withdrawal from the trial, and intervention fidelity were monitored during this process. Also, the children were monitored for fifteen minutes to see if they experienced any side effects related to the intervention.

Group Type: EXPERIMENTAL

The biofeedback-assisted VR game "Golden Breath"

Intervention Type: OTHER

The biofeedback-assisted VR game "Golden Breath" that we 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" u

Interventions

The biofeedback-assisted VR game "Golden Breath"

The biofeedback-assisted VR game "Golden Breath" that we 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" u

Intervention Type: OTHER

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Koç University

OTHER

Sponsor Role: lead

Responsible Party

Eysan Hanzade Umac

Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Eyşan Savaş

Role: CONTACT

eysansavas@gmail.com

5068418841

Other Identifiers

EU

Identifier Type: -

Identifier Source: org_study_id