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Behavioural Acceptability of PARO in Paediatric Dentistry : a Descriptive Observational Study

Behavioural Acceptability of the PARO Therapeutic Robot During Dental Treatment in Children With Cooperation Difficulties Following Unsuccessful Conventional Care: a Descriptive Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07824063
Enrollment
62
Registered
2026-09-17
Start date
2026-03-03
Completion date
2026-05-27
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety

Brief 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 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."

Interventions

DEVICEPARO socially assistive therapeutic robot

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.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Known fear of animals.

Design outcomes

Primary

MeasureTime frameDescription
Behavioural acceptability of PARO based on voluntary physical contactDuring 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.

Secondary

MeasureTime frameDescription
Clinical behaviour assessed using the Venham scale modified by VeerkampAt 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.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.
Perceptions of PARO by childrenAt the end of the dental visit.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.
Perceptions of PARO by carersAt the inclusionCarers' 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.
Perceptions of PARO by dental practitionersAt the inclusionDental 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026