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Clinical Trials/NCT05238246
NCT05238246CompletedNot Applicable

The Impact of a Humanoid Robot on Children's Dental Anxiety, Behavior and Salivary Amylase Levels

Istanbul University1 site in 1 country102 target enrollmentStarted: February 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
102
Locations
1
Primary Endpoint
Child's anxiety assessment

Study Overview

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.

Detailed Description

Selection and description of participants: 115 healthy children aged between 4 and 10 years, having their first dental visit and requiring a pulpotomy for a primary molar were selected from Istanbul University, Department of Pediatric Dentistry. The children accepting to response questionnaires and informed consent, were accompanied by at least one parent was obtained. Children having any history of systemic diseases or medically compromised were not included to the study. The study protocol was approved by the Ethical Committee of Istanbul University (2014/461).

Inclusion criteria were (a) healthy children, (b) no previous dental experience, (c) need pulpotomy in at least one mandibular primary molar. Exclusion criteria were (a) children showing definitely negative behaviour (Frankl 1) during dental prophylaxis at the first visit.

Randomization: A total of 115 patients who met the inclusion criteria were examined. Six children didn't want to participate for the treatment and five children couldn't spit enough for saliva collection. From the eligible 104 children were randomly selected and equally allocated into two groups.

Treatment procedure: The study protocol was explained to parents and their and written consent was obtained. Pre-treatment questionnaires were asked to the participants. All children were treated under local anaesthesia. The treatments were performed by the same dentist (YK). The robot group (RG) were treated with the robot accompaniment (n=50). The control group (CG) were treated with positive reinforcement and tell-show-do (n=52). Treatments were completed in the same session. One calibrated pediatric dentist [intra-class correlation coefficient (ICC) score = 0.87] performed pulpotomy treatment with inferior alveolar block. In the robot group, distraction and tell-show-do techniques were used by the humanoid robot. The robot used in experiments is NAO, manufactured by Softbank Robotics. NAO is a 58-cm tall robot allowing it to perform the targeted motor tasks. The robot was programmed to perform the same series of instructions for every patient to guarantee that all children had the same experience with the robot. The movements of the robot can be controlled wirelessly from a computer by using Choregraphe software. The investigators prepared the transactions to let the operator run the corresponding commands for each period of the treatment in real time to create sequences of behaviours. After each task is defined individually, it is assigned to a keyboard event. Some combinations of robot movements are achieved by pressing a single key. With this keyboard interface, the learning time of the operator has been minimized. At the same time, the effort to control the robot has been simplified and mistakes have been reduced.

Anxiety status: A series of questionnaires measuring anxiety were administered to each child, before treatment and after treatment. Facial Image Scale (FIS) is a commonly used scale to determine the dental anxiety levels of children. Children were asked to point at FIS before treatment. It consists five faces numbered from 1 to 5 and ranging between "very happy" and "very unhappy". Each child is asked to point to the face that they feel most closely, according to their feelings at that moment. The questionnaire was repeated after treatment. The Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) is 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. After the dental intervention, the children were asked would participants like to see the NAO again in their next appointment, who participated in robot group.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
4 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Robot group

Experimental

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

Intervention: Behavioral guidance with robot (Behavioral)

Standard treatment group

Sham Comparator

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

Intervention: Behavioral guidance with tell-show-do (Behavioral)

Outcomes

Primary Outcomes

Child's anxiety assessment

Time Frame: 30 minutes

• 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.

Secondary Outcomes

  • Salivary amylase activity(30 minutes)
  • Pulse rate(30 minutes)
  • Child's behaviour assessment(30 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yelda Kasımoğlu

Assoc. Prof.

Istanbul University

Study Sites (1)

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