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Behavior, ChildNCT05238246

Effect of a Humanoid Robot on Dental Anxiety in Children

A study testing Behavioral guidance with tell-show-do and Behavioral guidance with robot in people with Behavior, Child, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Behavior, Child
What is being tested?
Behavioral guidance with tell-show-do and Behavioral guidance with robot
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2017to 3 Dec 2018
Phase
Interventional
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 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University, Faculty of Dentistry

    Istanbul

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Behaviour assessment: Frankl's Behaviour Rating Scale (FBRS) were used by the dentist to assess each children's behaviour. The child's behaviour is classified by one of the following: definitely negative, negative, positive and definitely positive. Child's behaviour was evaluated at his/her first visit. Children with FBRS score 1 were excluded from the study. FBRS was repeated at the end of the treatment session.

Physiologic monitoring:

Pulse oximeter were used to measure physiological pulse rate (bpm) before, during and after treatment. Saliva was collected using the 'spitting method'. Each subject rinsed their mouth with water to reduce contamination of saliva with food debris and waited 5 minutes prior to sampling. Whole mouth saliva from the oral cavity was collected by asking the subjects to sit comfortably in an upright position and drop down their heads, let the saliva run naturally to the front of mouth without stimulating flow by oro-facial movements. Saliva that accumulates in the floor of mouth was expectorated into a graduated a polypropylene test tube every 30 s, for a total of 2 min. The amount of collected saliva in mL divided by the duration of the collection period, yielding ml/min was recorded as the mean salivary flow rate. Saliva samples were collected at three time points as follows: First saliva samples of children were collected 5 min before the dental intervention (pre-5, measuring the stress of being at the clinic). The patients then underwent dental procedures which lasted around 30 minutes. Right after dental care and after 10 minutes of resting (post-10), two new saliva samples were collected. Collection of at least 1 ml was required. After collection, the unprocessed samples were stored at -20°C until they were analyzed.

Conditions
Behavior, Child
Being tested
Behavioral guidance with tell-show-do, Behavioral guidance with robot
Keywords
dental anxiety, human computer interaction, robot, salivary amylase
Medical subject headings
Child Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral guidance with tell-show-doBehavioural

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

  • Behavioral guidance with robotBehavioural

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

Study groups in NCT05238246
Study groupRoleWhat they receive
Standard treatment groupSham comparatorDental treatment was carried out with tell-show-do technique as a behavioural guidance technique.
Receives: Behavioral: Behavioral guidance with tell-show-do
Robot groupExperimentalThe robot group (RG) were treated with the robot accompaniment
Receives: Behavioral: Behavioral guidance with robot

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 minutes

Secondary outcomes (3)
  1. Child's behaviour assessment

    • According to the The Frankl Behavior Rating Scale, the child's attitude towards treatment is divided into 4 groups and scored between 1-4 meaning: 1 point absolutely negative (child refuses treatment, strong fear and crying), 2 points negative (reluctant to accept treatment), 3 points positive (child accepts treatment, but is cowardly and timid) 4 points absolutely positive (compatible with pediatric dentist).

    Measured: 30 minutes

  2. Pulse rate

    Significant differences in heart rate was compared between groups

    Measured: 30 minutes

  3. Salivary amylase activity

    Saliva was collected using the 'spitting method'. Each subject rinsed their mouth with water to reduce contamination of saliva with food debris and waited 5 minutes prior to sampling. Whole mouth saliva from the oral cavity was collected by asking the subjects to sit comfortably in an upright position and drop down their heads, let the saliva run naturally to the front of mouth without stimulating flow by oro-facial movements. Saliva that accumulates in the floor of mouth was expectorated into a graduated a polypropylene test tube every 30 s, for a total of 2 min. The amount of collected saliva in mL divided by the duration of the collection period, yielding ml/min was recorded as the mean salivary flow rate.

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2022
  2. Study start1 Feb 2017
  3. Primary completion1 May 2017
  4. Study completion3 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Behavioral: Behavioral guidance Other: Physiological state Other: Dental anxiety assessment
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05238246
Sponsor's protocol ID
2014/461
Status last verified
Feb 2022
First submitted
4 Feb 2022
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral guidance with tell-show-do and Behavioral guidance with robot in people with Behavior, Child, run by Istanbul University at 1 site in Turkey (Türkiye).

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 3 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 29 Nov 2023. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?

Child's anxiety assessment (time frame: 30 minutes). 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 29 Nov 2023.

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