Pediatric CancerNCT06763042
Usability and Utility of Mindfulness-based Life Management Social Robots for Children and Adolescents in the Long-term Treatment
A study testing Mindfulness-based Life Management Social Robots in people with Pediatric Cancer and Psychology, Child, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to apply social robot-based mindfulness-based life management content to pediatric and adolescent patients in the long-term disease treatment process and to assess usability and effectiveness of the social robot-based mindfulness-based life management content. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pediatric Cancer, Psychology, Child
- What is being tested?
- Mindfulness-based Life Management Social Robots
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Sep 2023to 31 Jan 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 6 to 12 years old who is being treated after the diagnosis of a severe or chronic disease
- Pediatric patients who need hospital treatment, including inpatient or outpatient treatment, for more than 3 months
- Pediatric patients with a level of communication that can be understood and agreed to in this study
Who cannot join
- Those who disagree with this study
- Pediatric patients who are judged to be difficult to interact with robots due to communication difficulties
- Pediatric patients who has been diagnosed with or is being treated for mental illness with psychotic characteristics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Usability and Utility of Mindfulness-based Life Management Social Robots for Children and Adolescents in the Long-term Treatment Process
The purpose of this study is to apply social robot-based mindfulness-based life management content to pediatric and adolescent patients in the long-term disease treatment process and to assess usability and effectiveness of the social robot-based mindfulness-based life management content.
[Question 1] Effectiveness: Was the content on social robots effective in psychological adaptation of pediatric and adolescent patients?
Read more
[Question 2] Usability: Is there any difficulty in interacting through social robots applied in the hospital environment?
The participants conduct a preliminary survey and use robot content at least 10 times for the two weeks. Afterwards, follow-up surveys and in-depth interviews will be conducted.
Read the detailed description
The purpose of this study is to apply social robot-based mindfulness-based life management content to pediatric and adolescent patients in the long-term disease treatment process and to assess usability and effectiveness of the social robot-based mindfulness-based life management content.
[Intervention]
- Intervention period: 15-20 minutes or more per day for 14 days (at least 10 times in 2 weeks)
- Content: Life management content for mindfulness play and disease understanding
- Method of provision: Robot interaction using chatbot and remote conversation (mindfulness-based living management content and remote content will be provided for a total of 15 to 20 minutes)
[Question 1] Effectiveness: Was the content on social robots effective in psychological adaptation of pediatric and adolescent patients?
(Measure) Pre-post comparison of survey result values
- Child Emotional and Behavioral Disorder Assessment Scale (Korea-Child Behavior Checklist: K-CBCL) ② Child and Youth Mindfulness Scale (Korean Child and Adolescent Mindfulness Measure: K-CAMM) ③ Child and Youth Optimism Scale (The Children's Life Orientation Test: C-LOT)
[Question 2] Usability: Is there any difficulty in interacting through social robots applied in the hospital environment?
(Measure) User Experience Questionnaire(UEQ), In-depth Interview
- Conditions
- Pediatric Cancer, Psychology, Child
- Being tested
- Mindfulness-based Life Management Social Robots
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Life Management Social RobotsDevice
Mindfulness-based life management contents for pediatric patients operated by Social Robots
| Study group | Role | What they receive |
|---|---|---|
| Groups that use the Mindfulness-based Life Management Social Robots | Experimental | Intervention period: 15-20 minutes or more per day for 14 days (at least 10 times in 2 weeks)
Content: Life management content for mindfulness play and disease understanding
Method of provision: Robot interaction using chatbot and remote conversation (mindfulness-based living management content and remote content will be provided for a total of 15 to 20 minutes) Receives: Device: Mindfulness-based Life Management Social Robots |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation Scale of Child Emotional and Behavioral Disorders
Measure and compare the score of Korea-Child Behavior Checklist (K-CBCL) before and after intervention. Change in psychological adaptation scores among pediatric and adolescent patients as measured by a validated psychological adaptation questionnaire. The questionnaire includes subscales for emotional regulation, coping mechanisms, and social engagement. Results will be reported as mean changes in scores from baseline to 14 days.
Measured: 14 days
Measurement of Mindfulness Scale for Children and Adolescents
Measure and compare the score of Korean Child and Adolescent Mindfulness Measure (K-CAMM) before and after intervention. Change in psychological adaptation scores among pediatric and adolescent patients as measured by a validated psychological adaptation questionnaire. The questionnaire includes subscales for emotional regulation, coping mechanisms, and social engagement. Results will be reported as mean changes in scores from baseline to 14 days.
Measured: 14 days
Measurement of optimism in children and adolescents
Measure and compare the score of The Children's Life Orientation Test (CLOT) before and after intervention. Change in psychological adaptation scores among pediatric and adolescent patients as measured by a validated psychological adaptation questionnaire. The questionnaire includes subscales for emotional regulation, coping mechanisms, and social engagement. Results will be reported as mean changes in scores from baseline to 14 days.
Measured: 14 days
Secondary outcomes (2)
Measurement of Measurement User Experience Questionnaire Short Version (UEQs)
Measurement of Measurement User Experience Questionnaire Short Version (UEQs) after intervention. Number of reported difficulties in interacting with the social robot, as assessed by a semi-structured usability survey. The survey includes items on ease of interaction, clarity of instructions, and overall user satisfaction. Responses will be quantified on a Likert scale (1 = very difficult, 5 = very easy).
Measured: 14 days
In-depth interview
Interviews with study subjects based on the overall contents of the study
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start20 Sep 2023
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical trials with a single arm
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT06763042
- Sponsor's protocol ID
- 2023-03-057-006
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2023
- Last updated
- 8 Jan 2025
- 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Usability and Utility of Mindfulness-based Life Management Social Robots for Children and Adolescents in the Long-term Treatment Process
- ClinicalTrials.gov ID
- NCT06763042
- Acronym / sponsor ID
- 2023-03-057-006
- Conditions
- Pediatric Cancer, Psychology, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 8 Jan 2025 (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 apply social robot-based mindfulness-based life management content to pediatric and adolescent patients in the long-term disease treatment process and to assess usability and effectiveness of the social robot-based mindfulness-based life management content.
[Question 1] Effectiveness: Was the content on social robots effective in psychological adaptation of pediatric and adolescent patients?
[Question 2] Usability: Is there any difficulty in interacting through social robots applied in the hospital environment?
The participants conduct a preliminary survey and use robot content at least 10 times for the two weeks. Afterwards, follow-up surveys and in-depth interviews will be conducted.
Detailed description
The purpose of this study is to apply social robot-based mindfulness-based life management content to pediatric and adolescent patients in the long-term disease treatment process and to assess usability and effectiveness of the social robot-based mindfulness-based life management content.
[Intervention]
- Intervention period: 15-20 minutes or more per day for 14 days (at least 10 times in 2 weeks)
- Content: Life management content for mindfulness play and disease understanding
- Method of provision: Robot interaction using chatbot and remote conversation (mindfulness-based living management content and remote content will be provided for a total of 15 to 20 minutes)
[Question 1] Effectiveness: Was the content on social robots effective in psychological adaptation of pediatric and adolescent patients?
(Measure) Pre-post comparison of survey result values
- Child Emotional and Behavioral Disorder Assessment Scale (Korea-Child Behavior Checklist: K-CBCL) ② Child and Youth Mindfulness Scale (Korean Child and Adolescent Mindfulness Measure: K-CAMM) ③ Child and Youth Optimism Scale (The Children's Life Orientation Test: C-LOT)
[Question 2] Usability: Is there any difficulty in interacting through social robots applied in the hospital environment?
(Measure) User Experience Questionnaire(UEQ), In-depth Interview
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical trials with a single arm
| Arm | Type | Receives |
|---|---|---|
| Groups that use the Mindfulness-based Life Management Social Robots | Experimental | Device: Mindfulness-based Life Management Social RobotsIntervention period: 15-20 minutes or more per day for 14 days (at least 10 times in 2 weeks) Content: Life management content for mindfulness play and disease understanding Method of provision: Robot interaction using chatbot and remote conversation (mindfulness-based living management content and remote content will be provided for a total of 15 to 20 minutes) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients aged 6 to 12 years old who is being treated after the diagnosis of a severe or chronic disease
- Pediatric patients who need hospital treatment, including inpatient or outpatient treatment, for more than 3 months
- Pediatric patients with a level of communication that can be understood and agreed to in this study
Key exclusion criteria (3 listed)
- Those who disagree with this study
- Pediatric patients who are judged to be difficult to interact with robots due to communication difficulties
- Pediatric patients who has been diagnosed with or is being treated for mental illness with psychotic characteristics
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 Life Management Social RobotsMindfulness-based life management contents for pediatric patients operated by Social Robots | Device | Groups that use the Mindfulness-based Life Management Social Robots |
Primary outcome
Evaluation Scale of Child Emotional and Behavioral Disorders
Time frame: 14 days
Measure and compare the score of Korea-Child Behavior Checklist (K-CBCL) before and after intervention. Change in psychological adaptation scores among pediatric and adolescent patients as measured by a validated psychological adaptation questionnaire. The questionnaire includes subscales for emotional regulation, coping mechanisms, and social engagement. Results will be reported as mean changes in scores from baseline to 14 days.
Measurement of Mindfulness Scale for Children and Adolescents
Time frame: 14 days
Measure and compare the score of Korean Child and Adolescent Mindfulness Measure (K-CAMM) before and after intervention. Change in psychological adaptation scores among pediatric and adolescent patients as measured by a validated psychological adaptation questionnaire. The questionnaire includes subscales for emotional regulation, coping mechanisms, and social engagement. Results will be reported as mean changes in scores from baseline to 14 days.
Measurement of optimism in children and adolescents
Time frame: 14 days
Measure and compare the score of The Children's Life Orientation Test (CLOT) before and after intervention. Change in psychological adaptation scores among pediatric and adolescent patients as measured by a validated psychological adaptation questionnaire. The questionnaire includes subscales for emotional regulation, coping mechanisms, and social engagement. Results will be reported as mean changes in scores from baseline to 14 days.
2 secondary outcomes
Measurement of Measurement User Experience Questionnaire Short Version (UEQs)
Time frame: 14 days
In-depth interview
Time frame: 14 days
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 8 Jan 2025.
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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 Life Management Social Robots in people with Pediatric Cancer and Psychology, Child, 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 3 inclusion and 3 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 8 Jan 2025. 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?
Evaluation Scale of Child Emotional and Behavioral Disorders (time frame: 14 days). The study lists 3 primary outcomes in all. 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 8 Jan 2025.