Usability Evaluation of a Mindfulness-based Serious Game

Not Applicable

Completed

• Conditions: Pain, Chronic
• Interventions: Other: mindfulness-based serious games

• Registration Number: NCT06522425
• Lead Sponsor: Samsung Medical Center

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

Study Timeline

• Study Start: 2023-11-02
• Primary Completion: 2023-11-29
• Study Completion: 2024-06-17
• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Last Update Submitted: 2024-07-22
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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. *

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

   • Inclusion Criteria:

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
professionals	mindfulness-based serious games	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.
Users(pediatric patients)	mindfulness-based serious games	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.

Primary Outcome Measures

Name	Time	Method
Usability Evaluation of the Mindfulness-Based Serious Game	Immediately post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Qualitative Feedback from Interviews	Immediately post-intervention	Qualitative feedback will be collected through interviews conducted immediately after the intervention. These interviews will gather detailed insights into participants' experiences, including the game's usability, perceived benefits, ease of use, and overall satisfaction.

Trial Locations

Locations (1)

Samsung Medical Centre; 🇰🇷 Seoul, Korea, Republic of