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

NCT06427148 | Not Yet Recruiting

• 1 other identifier: EU
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pediatric Population

Outcome Measures

Primary Outcomes (4)

• Pain-Wong-Baker Pain Assessment Scale

  It is used to evaluate pain in children. The scale consists of six facial expressions. Facial expressions range from 0 points, "no pain-very happy" to 10 points, "unbearable pain-crying." (Wong-Baker Foundation. Home - wong-baker FACES foundation, 9.3.20. https://wongbakerfaces.org/)

  immediately after the intervention

• Fear- Child Fear Scale

  The scale consists of five facial expressions. In facial expressions, 0 indicates no fear, and 4 indicates severe fear (McKinley et al., 2008). The Turkish validity and reliability of the Child Fear Scale were conducted by Gerçeker and her colleagues (Özalp Gerçeker et al., 2018).

  baseline and immediately after the intervention

• GoldenBreath Evaluation Form

  The form created by researchers using the literature to get feedback from children about GoldenBreath consists of eight questions. It includes questions such as: Did you think the game was easy to play? Was the game suitable in terms of content? Was the sound level in the game appropriate? Was it easy for you to follow the instructions in the game? Was the use of the game sufficient in terms of time throughout the process? Is there a feature you would like to add to the game? Have you ever felt uncomfortable while playing the game?

  During the development phase of the game

• Mobile Application Usability Scale

  The scale was created by Hoehle (Hoehle, Aljafari, \& Venkatesh, 2016), and its Turkish adaptation was made by Güler in 2019 (Güler, 2019). This tool provides information about the colors, text styles, font sizes, transitivity, application management, etc., used in the mobile application. It is used to evaluate the properties. The scale is a 7-point Likert-type measurement tool and consists of a total of 40 questions. In our study, it was used to obtain expert opinions.

  During the development phase of the game

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Other: The biofeedback-assisted VR game "Golden Breath"

Interventions

The biofeedback-assisted VR game "Golden Breath" 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

Intervention

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Koç University: lead

Central Study Contacts

Eyşan Savaş

CONTACT

5068418841; eysansavas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 23, 2024
• Study Start: May 20, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share