Clinical trial NCT06522425: Usability Evaluation of a Mindfulness-based Serious Game
Official title: Evaluation of the Usability of Mindfulness-based Serious Games for Pediatric Patient Who Need Pain Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Keywords: Pain Management, Mindfulness, Serious Game
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 19
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 1. Users(Pediatric Patients)

   * 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.

Primary outcomes:
measure: Usability Evaluation of the Mindfulness-Based Serious Game
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: Qualitative Feedback from Interviews
timeFrame: Immediately post-intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Centre
Study officials:
affiliation: Samsung Medical Center
name: Meong hi Son
role: PRINCIPAL_INVESTIGATOR
References: