Pain, ChronicNCT06522425
Usability Evaluation of a Mindfulness-based Serious Game
A study testing mindfulness-based serious games in people with Pain, Chronic, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- mindfulness-based serious games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Nov 2023to 17 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Medical staff specializing in pediatric care or individuals with a doctoral degree in child development or psychology
- Able to provide voluntary informed consent.
Who cannot join
- 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
- Have visual or auditory impairments that would make it difficult to understand and play the game.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Usability of Mindfulness-based Serious Games for Pediatric Patient Who Need Pain Control
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.
Read the 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
- Being tested
- mindfulness-based serious games
- Keywords
- Pain Management, Mindfulness, Serious Game
- Medical subject headings
- Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based serious gamesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: mindfulness-based serious games |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately post-intervention
Secondary outcomes (1)
Qualitative Feedback from Interviews
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.
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start2 Nov 2023
- Primary completion29 Nov 2023
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meong hi Son, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522425
- Sponsor's protocol ID
- 2023-08-073
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Usability of Mindfulness-based Serious Games for Pediatric Patient Who Need Pain Control
- ClinicalTrials.gov ID
- NCT06522425
- Acronym / sponsor ID
- 2023-08-073
- Conditions
- Pain, Chronic
- Keywords
- Pain Management, Mindfulness, Serious Game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| professionals | Experimental | Other: mindfulness-based serious gamesThis 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) | Experimental | Other: mindfulness-based serious gamesThis 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
Key exclusion criteria (4 listed)
- Professionals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness-based serious gamesThe 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. | Other | Users(pediatric patients), professionals |
Primary outcome
Usability Evaluation of the Mindfulness-Based Serious Game
Time frame: 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.
1 secondary outcome
Qualitative Feedback from Interviews
Time frame: Immediately post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meong hi Son principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based serious games in people with Pain, Chronic, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability Evaluation of the Mindfulness-Based Serious Game (time frame: Immediately post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.