Usability Evaluation of a Mindfulness-based Serious Game

NCT06522425 | Completed

• 1 other identifier: 2023-08-073
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the usability of a mindfulness-based serious game developed for pediatric and adolescent patients who require pain management during their disease treatment. We conducted usability evaluations targeting both professional and user groups. Both groups experienced the mindfulness-based serious game and then participated in a usability survey and interview.

Conditions

Pain, Chronic

Keywords

Pain Management, Mindfulness, Serious Game

Outcome Measures

Primary Outcomes (1)

• Usability Evaluation of the Mindfulness-Based Serious Game

  The usability of the mindfulness-based serious game will be measured using the Mobile Application Rating Scale (MARS) and its user version (uMARS). These scales assess the app's engagement, functionality, aesthetics, information, subjective quality and app-specific quality.

  Immediately post-intervention

Secondary Outcomes (1)

• Qualitative Feedback from Interviews

  Immediately post-intervention

Study Arms (2)

professionals

EXPERIMENTAL

This arm includes 9 professionals (including medical staff, child development specialists, and psychologists). All participants will use the mindfulness-based serious game designed for pain management and will complete usability surveys and participate in interviews to provide feedback on their experience.

Other: mindfulness-based serious games

Users(pediatric patients)

EXPERIMENTAL

This arm includes 10 users (pediatric patients aged 5-17 years who are taking adjuvant analgesics or narcotic/non-narcotic analgesics for pain control). All participants will use the mindfulness-based serious game designed for pain management and will complete usability surveys and participate in interviews to provide feedback on their experience.

Other: mindfulness-based serious games

Interventions

mindfulness-based serious games OTHER

The intervention consists of a single session using a digital serious game designed to teach mindfulness techniques for pain management. In addition to explaining mindfulness concepts, the game provides a variety of mindfulness exercises to help users manage and reduce pain perception. For example, it involves relaxation through breathing or becoming aware of the state of one's body and mind. Additionally, it includes various interaction elements such as touch, voice, and motion controls to increase user immersion.

Users(pediatric patients); professionals

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients aged 5-17 years.
• Currently taking adjuvant analgesics or narcotic/non-narcotic analgesics for pain control.
• Able to provide voluntary assent and have parental/guardian consent.

You may not qualify if:

• Diagnosed with a psychiatric disorder characterized by psychotic features.
• Have visual or auditory impairments that would make it difficult to understand and play the game.
• Professionals
• Medical staff specializing in pediatric care or individuals with a doctoral degree in child development or psychology
• Able to provide voluntary informed consent.
• Have visual or auditory impairments that would make it difficult to understand and play the game.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Centre

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Meong hi Son

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: November 2, 2023
• Primary Completion: November 29, 2023
• Study Completion: June 17, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

KR (1)