Effectiveness of Robot-pets in Reducing Dental Anxiety in Children

August 6, 2024 updated by: Melis AKYILDIZ, Aydin Adnan Menderes University

Assessing the Effectiveness of Robot-pets in Reducing Dental Anxiety in Children: A Randomized Controlled Clinical Trial

Dental anxiety is a psychological condition marked by fear and worry about potential negative experiences during dental treatment, often accompanied by a feeling of loss of control. Dental anxiety is common in children and adolescents and is associated with a lower quality of life related to oral health. Furthermore, it correlates with an increased incidence of untreated caries. Using behavioral management techniques can help children cope with dental anxiety, making it easier for them to undergo treatment in a positive and healthy way.

Primarily aim of this study is to evaluate the effectiveness of using a robot-pet to reduce dental anxiety in children. Additionally, the research aims to compare the efficacy of this technique with the audiovisual distraction technique and to evaluate children's perceptions regarding the use of a robot-pet.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dental anxiety is a universal phenomenon that affects people of all ages in different countries. This condition negatively affects the quality of life related to oral health in children and adults. Dental anxiety has a negative impact on children's oral and dental health. Studies have reported that children with dental anxiety have poorer oral hygiene and untreated dental caries.

Basic behavior management strategies are commonly employed in dental offices to shape a child's behavior, teach coping skills, instill positive attitudes, build trust, and enable effective and efficient treatment. These strategies include traditional techniques such as tell-show-do and voice control, as well as contemporary techniques such as cognitive behavioral therapy and audio-visual distraction.

Tell-Show-Do (TSD) is a well-known basic behavioral technique. This technique involves verbally explaining dental procedures or instruments to the child using developmentally appropriate language. The visual, auditory, olfactory, and tactile aspects of the procedure are then demonstrated to the patient in a carefully defined, non-threatening environment. Finally, the procedure is performed without deviating from the initial explanation and demonstration.

Audiovisual distraction is a technique that combines visual and auditory components. It involves a spectacle system that consists of a head-mounted display and in-ear headphones. The aim is to reduce visual and auditory interference from the sounds and images of the dental working environment. This technique is intended to distract children during dental treatment by immersing them in a two- or three-dimensional world. According to some suggestions, this application may be more effective than traditional distraction methods due to its technological and engaging nature.

Animal-assisted therapy is a targeted intervention that uses a trained animal in a healthcare setting to improve patient interactions or reduce anxiety, pain, or distress. Appointments for animal-assisted therapy are scheduled for a specific time and duration, and the animals used have undergone temperament testing, rigorous training, and certification. According to a report, animals used during dental visits can help patients overcome communication barriers and reduce stress related to treatment by establishing a safe and relaxing relationship with the dentist. Animal-assisted therapies can increase children's compliance in the clinic and distract their attention. However, due to clinical hygiene conditions, it may pose risks to both trained animals and dental personnel. If necessary, precautions are taken, it can be applied. To eliminate the mentioned risks and difficulties, robots in cat/dog form can be used to apply this useful technique. In this context, it is important to keep up with developments in behavior management and assess their suitability for clinical practice. It is believed that using a robot-pet can enhance children's cooperation during dental procedures. This study provides guidance for clinicians on an alternative method of behavior management.

Methods:

A total of 72 children aged 6-10 years with no previous dental experience, needs fissure sealant treatment will be included in this study. Children will be randomly assigned to three groups according to received distraction technique during fissure sealant application; each group having 24 patients as follows: Group-1: Robot-Pet, Group-2:Virtual Reality Glasses, and Group 3: Tell-Show-Do (Control). Anxiety levels and behaviors will be assessed at different timepoints. Preoperative (T1) baseline levels of dental anxiety will be measured using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) and the Facial Image Scale (FIS), and behavior rating will be measured using the Frankl Behavior Rating Scale (FBRS). Intraoperative (T2) cooperation level will be recorded using the Modified Houpt Scale (MHS) during the surface cleaning (T2A), isolation (T2B) and washing (T2C) phases of fissure sealant application. Postoperative(T3) anxiety level and behavior rating measurements (CFSS-DS, FIS, FBRS) will be repeated. Physiological markers for dental anxiety, such as heart rate and oxygen saturation, will be measured at all time points (T1, T2A-B-C, T3). An independent evaluator, who will have been formally trained regarding the two behavior scales(FBRS,MHS), will observe and record all data. Children and parents in the Group 1 and 2 will received a questionnaire for their perception about the use of their distraction technique(T3).

Statistical Analyses:

The IBM SPSS Statistics for Windows, Version 25.0 (Released 2017, Armonk, NY: IBM Corp.) package program will be used for statistical analyses. Numeric variables without an issue of normal distribution fit will be compared among three groups using the One-Way Analysis of Variance (ANOVA) method. In cases where homogeneity is not established, the Welch Test will be employed for multiple comparisons, and Dunnett's T3 method for pairwise comparisons.All hypothesis tests will be conducted at a significance level of 0.05.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Efeler
      • Aydin, Efeler, Turkey, 09100
        • Melis AKYILDIZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: : Children are eligible for inclusion if;

  • They are 6 to 10 years old
  • They have no previous dental treatment
  • They have at least one of the permanent first molars is fully erupted

Exclusion Criteria: Children will be excluded from the study if;

  • They do not have a parental agreement to participate
  • They need emergency care, such as dental trauma or pain
  • They have incomplete eruption of all permanent first molars
  • They have special health care needs, intellectual disabilities or autism spectrum disorders
  • They have phobia of animals such as cats or dogs
  • If their Frankl Behaviour Rating Score is 1 (Strongly Negative)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Robot-Pet Group
The robot-pet sits on the child's lap while the fissure sealant is applied. Preoperative (T1) baseline levels of dental anxiety will be measured using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) and the Facial Image Scale (FIS), and behavior rating will be measured using the Frankl Behavior Rating Scale (FBRS). Intraoperative (T2) cooperation level will be recorded using the Modified Houpt Scale (MHS) during the surface cleaning (T2A), isolation (T2B) and washing (T2C) phases of fissure sealant application. Postoperative(T3) anxiety level and behavior rating measurements (CFSS-DS, FIS, FBRS) will be repeated. Physiological markers for dental anxiety, such as heart rate and oxygen saturation, will be measured at all time points (T1, T2A-B-C, T3). Children and parents in this group will received a questionnaire for their perception about the use of their distraction technique(T3).
Device: Robot-Pet
The robot-pet makes sounds like a real cat and responds to touch and petting
Active Comparator: Virtual Reality Glasses Group
During the application of fissure sealant, the child watches a cartoon through virtual reality glasses. Preoperative (T1) baseline levels of dental anxiety will be measured using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) and the Facial Image Scale (FIS), and behavior rating will be measured using the Frankl Behavior Rating Scale (FBRS). Intraoperative (T2) cooperation level will be recorded using the Modified Houpt Scale (MHS) during the surface cleaning (T2A), isolation (T2B) and washing (T2C) phases of fissure sealant application. Postoperative(T3) anxiety level and behavior rating measurements (CFSS-DS, FIS, FBRS) will be repeated. Physiological markers for dental anxiety, such as heart rate and oxygen saturation, will be measured at all time points (T1, T2A-B-C, T3). Children and parents in this group will received a questionnaire for their perception about the use of their distraction technique(T3).
Device: Virtual Reality Glasses
VR glasses allow you to see videos and films projected on the screen more realistic. With its filtering feature, it combines two different images in the brain and provides the perception of depth in the image and creates a 3D space environment
No Intervention: Control Group
Tell-Show-Do technique will be used to apply the fissure sealant. No additional distraction will be applied. Preoperative (T1) baseline levels of dental anxiety will be measured using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) and the Facial Image Scale (FIS), and behavior rating will be measured using the Frankl Behavior Rating Scale (FBRS). Intraoperative (T2) cooperation level will be recorded using the Modified Houpt Scale (MHS) during the surface cleaning (T2A), isolation (T2B) and washing (T2C) phases of fissure sealant application. Postoperative(T3) anxiety level and behavior rating measurements (CFSS-DS, FIS, FBRS) will be repeated. Physiological markers for dental anxiety, such as heart rate and oxygen saturation, will be measured at all time points (T1, T2A-B-C, T3).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assesment of Heart Rate and Oxygen Saturations
Time Frame: Before Treatment, During Fissure Sealant Application-Surface Cleaning Phase, During Fissure Sealant Application-Isolation Phase, During Fissure Sealant Application-Washing Phase, Immediately After Treatment
Evaluation of the physiological parameters heart rate and oxygen saturation shows the interaction between the autonomic nervous system and dental anxiety. These values provide information about the children's cardiovascular and respiratory responses during treatment.
Before Treatment, During Fissure Sealant Application-Surface Cleaning Phase, During Fissure Sealant Application-Isolation Phase, During Fissure Sealant Application-Washing Phase, Immediately After Treatment
Assesment of Behaviour- Frankl Behaviour Rating Scale
Time Frame: Before Treatment, Immediately After Treatment
Dental professionals uses this scale to systematically assess and record information about child's behaviour in the dental clinic environment.The behaviour is rated from 1 to 4 (strongly negative (1), negative (2), positive (3), strongly positive (4))
Before Treatment, Immediately After Treatment
Assesment Of Behaviour- Modified Houpt Behaviour Rating Scale
Time Frame: During Fissure Sealant Application-Surface Cleaning Phase, During Fissure Sealant Application-Isolation Phase, During Fissure Sealant Application-Washing Phase

This is a three-stage scale designed to assess the child's compliance and cooperative behaviour during dental treatment. It is a scale in which the child is assessed by the dental practitioner on three different parameters relating to movement, crying and overall behaviour and scored from 1 to 4 according to their behaviour.

Movement: 1=no movement 2= Controllable movement 3=Continuous movement 4=Violent movement Crying: 1= No crying 2= Intermittent mild crying 3= Continuous persistent crying 4= Hysterical crying Overall Behaviour: 1= Excellent, treatment completed 2= air, treatment interrupted, but eventually all completed 3= oor, treatment interrupted, only partial treatment completed 4= Aborted, no treatment rendered
During Fissure Sealant Application-Surface Cleaning Phase, During Fissure Sealant Application-Isolation Phase, During Fissure Sealant Application-Washing Phase
Assesment of Dental Anxiety- Children's Fear Survey Schedule-Dental Subscale
Time Frame: Before Treatment, Immediately After Treatment

The Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) is a specific tool designed to assess dental anxiety and fear in children.

  1. Dentists
  2. Doctors
  3. Injections
  4. Having somebody examine your mouth
  5. Having to open your mouth
  6. Having a stranger touch you
  7. Having somebody look at you
  8. The dentist drilling.
  9. The sight of the dentist drilling
  10. The noise of the dentist drilling
  11. Having somebody put instruments in your mouth
  12. Choking
  13. Having to go to the hospital
  14. People in white uniforms
  15. Having the dentist clean your teeth Each item was scored between 1-5 according to the answer given (Scoring is as follows: 1= Not afraid at all, 2= A little afraid, 3= Moderately afraid, 4= Quite afraid, 5= Very afraid).
Before Treatment, Immediately After Treatment
Assesment of Dental Anxiety- Facial Image Scale
Time Frame: Before Treatment, Immediately After Treatment
The Facial Image Scale consists of a series of five faces ranging from very happy to very unhappy. Children were asked to point to which face they felt most like at that moment. The scale is scored by rating the face with the most positive affect as 1(Very Happy) and the face with the most negative affect as 5(Very Unhappy).
Before Treatment, Immediately After Treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate the Child's Perspectives on the Use of Robot-Pet
Time Frame: Immediately After Treatment

A questionnaire will be carried out through an interview with children to determine what their perception of robot-pet.

  1. I liked having a robot cat on my lap.
  2. It felt good to be treated with a robot cat on my lap.
  3. Dental treatments are easier when I have a robot cat on my lap.
  4. I will tell my friends that I have been treated with a robot cat.
  5. I would have the treatment even if I did not have a robot cat on my lap. The scale is 1 (strongly agree) 2 (agree) 4 (no opinion) 4 (disagree) 5 (strongly disagree) A higher score indicates a worse outcome.
Immediately After Treatment
Assesment of Parents' Perspectives on the Use of Robot-Pet
Time Frame: Immediately After Treatment

A questionnaire will be carried out through an interview with parents to determine what their perception of robot-pet.

  1. Treatment with robot cat helped my child cope with dental anxiety.
  2. I would recommend treatment with a robot cat to others.. The scale is 1 (strongly agree) 2 (agree) 4 (no opinion) 4 (disagree) 5 (strongly disagree) A higher score indicates a worse outcome.
Immediately After Treatment
Evaluate the Child's Perspectives on the Use of Virtual Reality Glasses
Time Frame: Immediately After Treatment

A questionnaire will be carried out through an interview with children to determine what their perception of virtual reality glasses.

  1. I liked watching cartoons with glasses.
  2. It felt good to be treated while watching cartoons with glasses.
  3. Dental treatment will be easier when I watch cartoons with glasses.
  4. I will tell my friends that I was treated by watching cartoons with glasses.
  5. Even if I didn't watch cartoons with glasses, I would have the treatment. The scale is 1 (strongly agree) 2 (agree) 4 (no opinion) 4 (disagree) 5 (strongly disagree) A higher score indicates a worse outcome.
Immediately After Treatment
Assesment of Parents' Perspectives on the use Virtual Reality Glasses
Time Frame: Immediately After Treatment

A questionnaire will be carried out through an interview with parents to determine what their perception of virtual reality glasses.

  1. Treatment with virtual reality glasses helped my child cope with dental anxiety.
  2. I would recommend treatment with virtual reality glasses to others. The scale is 1 (strongly agree) 2 (agree) 4 (no opinion) 4 (disagree) 5 (strongly disagree) A higher score indicates a worse outcome.
Immediately After Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aydin Adnan Menderes University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Melis AKYILDIZ, PhD, Aydin Adnan Menderes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADUDHF-2023/23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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