Social IsolationBUDDY-GUARDNCT06405620
Use of a Social Assistance Robot in a Population of Children Subjected to Prolonged Isolation
A study testing Assistance robot in people with Social Isolation, run by University Hospital, Toulouse at 1 site in France.
Trial summary
During the period of isolation of the hospitalized child, contacts between the child and his family are impaired. Being away from home as well as from the social and family circle can be harmful for the hospitalized child. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Social Isolation
- What is being tested?
- Assistance robot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2024to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children hospitalized in the pediatric hemato-oncology department whose duration of isolation is estimated to be greater than two weeks.
- Children who have accepted the robot and whose parents have accepted its use in their home.
- Agreement of holders of parental authority for the inclusion of the hospitalized child.
Who cannot join
- Patient or two parents who do not have a sufficient level of French for research.
- Cognitive or motor disorders in children, not allowing the use of the robot and/or the carrying out of semi-structured interviews.
- Cognitive disorders in parents and/or siblings that do not allow semi-structured interviews to be carried out.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Children University Hospital of Toulouse
Toulouse
About this study
Official title: Mixed Observational Study Evaluating the Use of a Social Assistance Robot in a Population of Children Subjected to Prolonged Isolation
During the period of isolation of the hospitalized child, contacts between the child and his family are impaired. Being away from home as well as from the social and family circle can be harmful for the hospitalized child. It seems necessary to measure the impact of the use of such an assistance robot both on the user himself and his family. Thus, it seems relevant to scientifically validate the benefit of using such an assistance robot to break iatrogenic social isolation and to measure the impact of this use.
- Conditions
- Social Isolation
- Being tested
- Assistance robot
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assistance robotOther
the child controls the robot at his parent's home from his room
| Study group | Role | What they receive |
|---|---|---|
| Robot intervention | Experimental | the child uses the assistance robot Receives: Other: Assistance robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the use of a social assistance robot with children hospitalized in the hemato-oncology department and subjected to prolonged isolation
number of activations of the robot and duration of the activations
Measured: 1 month
Secondary outcomes (2)
Psychological impact of the use of a social assistance robot on the child, his parents and his siblings
psychological effects measured by semi-directive interviews of the parents and the brothers and sisters
Measured: Visit 1 between Day 10 and Day 20 et visit 2 between Day 21 and Day 45
Psychological effect of the use of a social assistance robot on the practice of nursing professionals in the service
The effects will be explored through semi-structured interviews of nursing professionnals.
Measured: Visit 2 between Day 21 and Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jun 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rémi IZOULET, Principal investigator, Toulouse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405620
- Sponsor's protocol ID
- RC31/23/0168
- Acronym
- BUDDY-GUARD
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed Observational Study Evaluating the Use of a Social Assistance Robot in a Population of Children Subjected to Prolonged Isolation
- ClinicalTrials.gov ID
- NCT06405620
- Acronym / sponsor ID
- BUDDY-GUARD / RC31/23/0168
- Conditions
- Social Isolation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 8 May 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.
During the period of isolation of the hospitalized child, contacts between the child and his family are impaired. Being away from home as well as from the social and family circle can be harmful for the hospitalized child. It seems necessary to measure the impact of the use of such an assistance robot both on the user himself and his family. Thus, it seems relevant to scientifically validate the benefit of using such an assistance robot to break iatrogenic social isolation and to measure the impact of this use.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot intervention | Experimental | Other: Assistance robotthe child uses the assistance robot |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children hospitalized in the pediatric hemato-oncology department whose duration of isolation is estimated to be greater than two weeks.
- Children who have accepted the robot and whose parents have accepted its use in their home.
- Agreement of holders of parental authority for the inclusion of the hospitalized child.
Key exclusion criteria (3 listed)
- Patient or two parents who do not have a sufficient level of French for research.
- Cognitive or motor disorders in children, not allowing the use of the robot and/or the carrying out of semi-structured interviews.
- Cognitive disorders in parents and/or siblings that do not allow semi-structured interviews to be carried out.
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 |
|---|---|---|
| Assistance robotthe child controls the robot at his parent's home from his room | Other | Robot intervention |
Primary outcome
Evaluate the use of a social assistance robot with children hospitalized in the hemato-oncology department and subjected to prolonged isolation
Time frame: 1 month
number of activations of the robot and duration of the activations
2 secondary outcomes
Psychological impact of the use of a social assistance robot on the child, his parents and his siblings
Time frame: Visit 1 between Day 10 and Day 20 et visit 2 between Day 21 and Day 45
Psychological effect of the use of a social assistance robot on the practice of nursing professionals in the service
Time frame: Visit 2 between Day 21 and Day 45
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Social Isolation
Not yet recruiting
A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement
Memory Disorders, Mild Cognitive Impairment
Recruiting
Does Attachment Anxiety Moderate the Influence of Social Rejection on Alcohol Use Among Young Adults?
Social Rejection, Attachement Style
Active, not recruiting
Multimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone
Social Isolation in Older Adults, Poverty
Recruiting
Social Connection Collective for Older Adults in Subsidized Housing
Social Isolation in Older Adults, Social Isolation or Loneliness
Not yet recruiting
Improving Diet Quality of Community-Dwelling Seniors Using a Community-Based Participatory Approach
Diet Quality, Social Isolation in Older Adults
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.
Rémi IZOULET principal investigator
Toulouse Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assistance robot in people with Social Isolation, run by University Hospital, Toulouse at 1 site in France.
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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadege ALGANS (0561777204, algans.n@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the use of a social assistance robot with children hospitalized in the hemato-oncology department and subjected to prolonged isolation (time frame: 1 month). 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 21 Sep 2026.