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Completed

NCT Number: NCT07824063

Behavioural Acceptability of PARO in Paediatric Dentistry : 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."

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Key information

Conditions

Dental Anxiety

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nice

Nice, Alpes Maritimes, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PARO socially assistive therapeutic robot

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. Perceptions of PARO by children

    Time frame: At 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.

  3. Perceptions of PARO by carers

    Time frame: At the inclusion

    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.

  4. Perceptions of PARO by dental practitioners

    Time frame: At the inclusion

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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