Effect of a Humanoid Robot on Dental Anxiety in Children

NCT05238246 | Completed DMC

• 1 other identifier: 2014/461
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Dental anxiety causes unwanted distresses in children. The present study is aimed to analyze using both technological and psychological distraction in children aged 4-10 with a humanoid robot. Materials and Methods: One hundred and two children (fifty two girls, fifty boys; mean age: 6.71±1.43 years) were included. Fifty children were participated in robot group and fifty two children were participated in control. Salivary alpha amylase were analyzed before, after, and 10 min after treatment. Frankl Behaviour Rating Scale (FBRS), Facial Image Scale (FIS), salivary amylase levels, and physiological pulse rate were used to assess the stress related changes. Statistical tests were used with p value fixed at 0.05.

Conditions

Behavior, Child

Keywords

dental anxiety; human computer interaction; robot; salivary amylase

Outcome Measures

Primary Outcomes (1)

• Child's anxiety assessment

  • The Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) was used in the assessment of dental anxiety in children. It consists of 15 questions. Children are asked to give scores from 1 (not afraid) to 5 (very afraid) for each question. The total score is between 15 and 75 points. Children with CFSS-DS ≥38 were defined as dentally anxious.

  30 minutes

Secondary Outcomes (3)

• Child's behaviour assessment

  30 minutes

• Pulse rate

  30 minutes

• Salivary amylase activity

  30 minutes

Study Arms (2)

Standard treatment group

SHAM COMPARATOR

Dental treatment was carried out with tell-show-do technique as a behavioural guidance technique.

Behavioral: Behavioral guidance with tell-show-do

Robot group

EXPERIMENTAL

The robot group (RG) were treated with the robot accompaniment

Behavioral: Behavioral guidance with robot

Interventions

Behavioral guidance with tell-show-do BEHAVIORAL

The effect of tell-show-do technique during dental treatment on behavior in pediatric patients was evaluated and compared.

Standard treatment group

Behavioral guidance with robot BEHAVIORAL

The effect of the tell-show-do and distraction technique during dental treatment on behavior in pediatric patients was evaluated and compared.

Robot group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy children
• no previous dental experience
• need pulpotomy in at least one mandibular primary molar

You may not qualify if:

• Children showing definitely negative behaviour (Frankl 1) during dental prophylaxis at the first visit.

Sponsors & Collaborators

• Istanbul University: lead
• Istanbul Technical University: collaborator

Study Sites (1)

Istanbul University, Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Behavioral: Behavioral guidance Other: Physiological state Other: Dental anxiety assessment

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 14, 2022
• Study Start: February 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: December 3, 2018
• Last Updated: November 29, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)