Dental AnxietyNCT07824063
Behavioural Acceptability of PARO in Paediatric Dentistry : a Descriptive Observational Study
An observational study of Dental Anxiety, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Socially assistive robots are increasingly being studied as tools to support children during healthcare procedures. This observational study aimed to assess the behavioural acceptability of the PARO therapeutic zoomorphic robot, designed in the form of a baby seal, during dental treatment in children aged 4 to 15… Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- PARO socially assistive therapeutic robot
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2026to 27 May 2026
- Phase
- Observational
- 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 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children referred to the specialised paediatric dentistry unit at Nice University Hospital after unsuccessful conventional dental management because the planned dental treatment could not be completed due to anxiety or cooperation difficulties.
Who may be able to join
- Children aged 4 to 15 years referred following unsuccessful conventional dental management, defined as the inability to carry out the planned dental treatment because of anxiety or cooperation difficulties.
Who cannot join
- Known fear of animals.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioural Acceptability of the PARO Therapeutic Robot During Dental Treatment in Children With Cooperation Difficulties Following Unsuccessful Conventional Care: a Descriptive Observational Study
Socially assistive robots are increasingly being studied as tools to support children during healthcare procedures. This observational study aimed to assess the behavioural acceptability of the PARO therapeutic zoomorphic robot, designed in the form of a baby seal, during dental treatment in children aged 4 to 15 years with cooperation difficulties following unsuccessful conventional behavioural management. Behavioural acceptability was assessed by measuring the proportion of the dental treatment session during which the child voluntarily maintained physical contact with PARO. High behavioural acceptability was defined as voluntary physical contact maintained for at least 75% of the treatment time. The study also assessed changes in the children's behaviour during the dental appointment, their spontaneous reactions to PARO, and the perceptions of the children, their carers and the dental practitioners."
- Conditions
- Dental Anxiety
- Being tested
- PARO socially assistive therapeutic robot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARO socially assistive therapeutic robotDevice
PARO is a socially assistive zoomorphic therapeutic robot designed in the form of a baby seal. It was introduced to the child before dental treatment. After a familiarisation period, the child was free to interact with PARO and to keep or remove the robot during the treatment session. Dental treatment was provided according to usual clinical needs.
| Study group | Role | What they receive |
|---|---|---|
| Children Exposed to PARO | PARO is a socially assistive zoomorphic therapeutic robot designed in the form of a baby seal. It was introduced to the child before dental treatment. After a familiarisation period, the child was free to interact with PARO and to keep or remove the robot during the treatment session. Dental treatment was provided according to usual clinical needs. Receives: Device: PARO socially assistive therapeutic robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural acceptability of PARO based on voluntary physical contact
Behavioural acceptability was measured as the percentage of dental treatment time during which the child voluntarily maintained physical contact with PARO. Values ranged from 0% to 100%, with higher percentages indicating greater behavioural acceptability. High behavioural acceptability was predefined as voluntary physical contact maintained for at least 75% of the treatment time.
Measured: During the dental treatment session at inclusion, from the start to the end of dental treatment.
Secondary outcomes (4)
Clinical behaviour assessed using the Venham scale modified by Veerkamp
The child's clinical behaviour, including observable manifestations of anxiety and cooperation, was assessed by the dental practitioner using the Venham scale modified by Veerkamp, ranging from 0 to 5, with higher scores indicating greater anxiety and poorer cooperation.
Measured: At four time points during the dental treatment session: before PARO introduction, immediately after PARO introduction, throughout dental treatment, and at the end of the session.
Perceptions of PARO by children
Children's perception of PARO was assessed at the end of the dental visit using one item from a study-specific structured questionnaire, rated on a six-point pictorial facial scale. The first face corresponded to the most favourable perception and the last face to the least favourable perception of PARO.
Measured: At the end of the dental visit.
Perceptions of PARO by carers
Carers' overall perception of PARO was assessed at the end of the dental visit using one item from a study-specific structured questionnaire. Responses were recorded using five categories: positive, rather positive, rather negative, negative, or no opinion. Positive and rather positive responses were considered favourable perceptions.
Measured: At the inclusion
Perceptions of PARO by dental practitioners
Dental practitioners' overall perception of PARO's impact on the child was assessed at the end of the dental visit using one item from a study-specific structured questionnaire. Responses were recorded using five categories: positive, rather positive, rather negative, negative, or no opinion. Positive and rather positive responses were considered favourable perceptions.
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start3 Mar 2026
- Primary completion27 May 2026
- Study completion27 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824063
- Sponsor's protocol ID
- 26Odonto01
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Acceptability of the PARO Therapeutic Robot During Dental Treatment in Children With Cooperation Difficulties Following Unsuccessful Conventional Care: a Descriptive Observational Study
- ClinicalTrials.gov ID
- NCT07824063
- Acronym / sponsor ID
- 26Odonto01
- Conditions
- Dental Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 27 May 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 17 Sep 2026 (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.
Socially assistive robots are increasingly being studied as tools to support children during healthcare procedures. This observational study aimed to assess the behavioural acceptability of the PARO therapeutic zoomorphic robot, designed in the form of a baby seal, during dental treatment in children aged 4 to 15 years with cooperation difficulties following unsuccessful conventional behavioural management. Behavioural acceptability was assessed by measuring the proportion of the dental treatment session during which the child voluntarily maintained physical contact with PARO. High behavioural acceptability was defined as voluntary physical contact maintained for at least 75% of the treatment time. The study also assessed changes in the children's behaviour during the dental appointment, their spontaneous reactions to PARO, and the perceptions of the children, their carers and the dental practitioners."
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children Exposed to PARO | – | Device: PARO socially assistive therapeutic robotPARO is a socially assistive zoomorphic therapeutic robot designed in the form of a baby seal. It was introduced to the child before dental treatment. After a familiarisation period, the child was free to interact with PARO and to keep or remove the robot during the treatment session. Dental treatment was provided according to usual clinical needs. |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children referred to the specialised paediatric dentistry unit at Nice University Hospital after unsuccessful conventional dental management because the planned dental treatment could not be completed due to anxiety or cooperation difficulties.
Key inclusion criteria (1 listed)
- Children aged 4 to 15 years referred following unsuccessful conventional dental management, defined as the inability to carry out the planned dental treatment because of anxiety or cooperation difficulties.
Key exclusion criteria (1 listed)
- Known fear of animals.
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 |
|---|---|---|
| PARO socially assistive therapeutic robotPARO is a socially assistive zoomorphic therapeutic robot designed in the form of a baby seal. It was introduced to the child before dental treatment. After a familiarisation period, the child was free to interact with PARO and to keep or remove the robot during the treatment session. Dental treatment was provided according to usual clinical needs. | Device | Children Exposed to PARO |
Primary outcome
Behavioural acceptability of PARO based on voluntary physical contact
Time frame: During the dental treatment session at inclusion, from the start to the end of dental treatment.
Behavioural acceptability was measured as the percentage of dental treatment time during which the child voluntarily maintained physical contact with PARO. Values ranged from 0% to 100%, with higher percentages indicating greater behavioural acceptability. High behavioural acceptability was predefined as voluntary physical contact maintained for at least 75% of the treatment time.
4 secondary outcomes
Clinical behaviour assessed using the Venham scale modified by Veerkamp
Time frame: At four time points during the dental treatment session: before PARO introduction, immediately after PARO introduction, throughout dental treatment, and at the end of the session.
Perceptions of PARO by children
Time frame: At the end of the dental visit.
Perceptions of PARO by carers
Time frame: At the inclusion
Perceptions of PARO by dental practitioners
Time frame: At the inclusion
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 17 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Anxiety, run by Centre Hospitalier Universitaire de Nice 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 1 inclusion and 1 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 17 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?
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?
Behavioural acceptability of PARO based on voluntary physical contact (time frame: During the dental treatment session at inclusion, from the start to the end of dental treatment.). 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 17 Sep 2026.