Usability Evaluation of a Mindfulness-based Serious Game

NCT ID: NCT06522425

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-02
• Study Completion Date: 2024-06-17

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.

Detailed Description

Background : Pain management is a critical aspect of treatment for pediatric and adolescent patients, especially those undergoing long-term or chronic disease management. Traditional pain management strategies often include pharmacological interventions, which may not be sufficient on their own and can have undesirable side effects. Consequently, there is a growing interest in complementary approaches that can enhance pain management and provide holistic care.

Mindfulness-based interventions have been shown to be effective in managing chronic pain by helping individuals develop a greater awareness of their physical and emotional states, thereby reducing the perception of pain. Serious games, which incorporate elements of play and interaction, offer a novel and engaging way to deliver mindfulness training. These games can be particularly appealing to younger patients, making it easier to integrate mindfulness practices into their daily routines.

Objective : The purpose of this study was to evaluate the usability of a mindfulness-based serious game developed for pediatric and adolescent patients who require pain management during their disease treatment.

Design: mixed-methods design Setting: In the emergency department at Samsung Medical Center Enrollment : 9 professionals (e.g., medical staff, child development specialists, and psychologists) and 10 pediatric and adolescent patients.

Intervention : Both professional and pediatric and adolescent patient groups experience a mindfulness-based functional game developed for pain management through a tablet.

Scoring : Usability is measured using the MARS (Mobile Application Rating Scale) and uMARS (user version of the Mobile Application Rating Scale) in a group of professionals and pediatric and adolescent patients. (Full score of MARS: 145, Full score of uMARS: 130).

Study period : For 1 hour after study enrollment, Usability survey : After experiencing a mindfulness-based functional game

Conditions

Pain, Chronic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

professionals

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.

Group Type: EXPERIMENTAL

mindfulness-based serious games

Intervention Type: 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)

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.

Group Type: EXPERIMENTAL

mindfulness-based serious games

Intervention Type: 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.

Interventions

mindfulness-based serious games

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Pediatric patients aged 5-17 years.

2. Currently taking adjuvant analgesics or narcotic/non-narcotic analgesics for pain control.

3. Able to provide voluntary assent and have parental/guardian consent.

1. Medical staff specializing in pediatric care or individuals with a doctoral degree in child development or psychology

2. Able to provide voluntary informed consent.

Exclusion Criteria

1. Diagnosed with a psychiatric disorder characterized by psychotic features.

2. Have visual or auditory impairments that would make it difficult to understand and play the game.

2. Professionals

1. Have visual or auditory impairments that would make it difficult to understand and play the game.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meong hi Son

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Centre

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2023-08-073

Identifier Type: -

Identifier Source: org_study_id