Dental AnxietyNCT06243705
Effectiveness of Robot-pets in Reducing Dental Anxiety in Children
A study testing Robot-Pet and Virtual Reality Glasses in people with Dental Anxiety, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Robot-Pet and Virtual Reality Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2023to 17 May 2024
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Anxiety
- Being tested
- Robot-Pet, Virtual Reality Glasses
- Keywords
- Behaviour management, Robot pet, Dental anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-PetDevice
The robot-pet makes sounds like a real cat and responds to touch and petting
Virtual Reality GlassesDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Robot-Pet Group | Experimental | 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). Receives: Device: Robot-Pet |
| Virtual Reality Glasses Group | Active comparator | 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). Receives: Device: Virtual Reality Glasses |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Assesment of Heart Rate and Oxygen Saturations
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.
Measured: 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
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))
Measured: Before Treatment, Immediately After Treatment
Assesment Of Behaviour- Modified Houpt Behaviour Rating Scale
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
Measured: 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
The Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) is a specific tool designed to assess dental anxiety and fear in children.
- Dentists
- Doctors
- Injections
- Having somebody examine your mouth
- Having to open your mouth
- Having a stranger touch you
- Having somebody look at you
- The dentist drilling.
- The sight of the dentist drilling
- The noise of the dentist drilling
- Having somebody put instruments in your mouth
- Choking
- Having to go to the hospital
- People in white uniforms
- 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).
Measured: Before Treatment, Immediately After Treatment
Assesment of Dental Anxiety- Facial Image Scale
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).
Measured: Before Treatment, Immediately After Treatment
Secondary outcomes (4)
Evaluate the Child's Perspectives on the Use of Robot-Pet
A questionnaire will be carried out through an interview with children to determine what their perception of robot-pet.
- I liked having a robot cat on my lap.
- It felt good to be treated with a robot cat on my lap.
- Dental treatments are easier when I have a robot cat on my lap.
- I will tell my friends that I have been treated with a robot cat.
- 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.
Measured: Immediately After Treatment
Assesment of Parents' Perspectives on the Use of Robot-Pet
A questionnaire will be carried out through an interview with parents to determine what their perception of robot-pet.
- Treatment with robot cat helped my child cope with dental anxiety.
- 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.
Measured: Immediately After Treatment
Evaluate the Child's Perspectives on the Use of Virtual Reality Glasses
A questionnaire will be carried out through an interview with children to determine what their perception of virtual reality glasses.
- I liked watching cartoons with glasses.
- It felt good to be treated while watching cartoons with glasses.
- Dental treatment will be easier when I watch cartoons with glasses.
- I will tell my friends that I was treated by watching cartoons with glasses.
- 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.
Measured: Immediately After Treatment
Assesment of Parents' Perspectives on the use Virtual Reality Glasses
A questionnaire will be carried out through an interview with parents to determine what their perception of virtual reality glasses.
- Treatment with virtual reality glasses helped my child cope with dental anxiety.
- 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.
Measured: Immediately After Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start2 Oct 2023
- Primary completion3 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be used a parallel-group randomized controlled trial design. Children fulfilling the inclusion criteria will be randomized to three group. Fissure sealants will be applied to the children using the distraction technique determined by randomisation.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melis AKYILDIZ, Aydin Adnan Menderes University
- Investigators
- Melis AKYILDIZ, PhD, Study director, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243705
- Sponsor's protocol ID
- ADUDHF-2023/23
- Status last verified
- Aug 2024
- First submitted
- 25 Jan 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gilchrist F, Campbell C. Communication and the Use of Language. In: Dental Fear and Anxiety in Pediatric Patients. Cham: Springer International Publishing; 2017. p. 117-36.
Gilchrist F, Marshman Z, Deery C, Rodd HD. The impact of dental caries on children and young people: what they have to say? Int J Paediatr Dent. 2015 Sep;25(5):327-38. doi: 10.1111/ipd.12186. Epub 2015 Jul 8.
PubMed 26153526Alsadat FA, El-Housseiny AA, Alamoudi NM, Elderwi DA, Ainosa AM, Dardeer FM. Dental fear in primary school children and its relation to dental caries. Niger J Clin Pract. 2018 Nov;21(11):1454-1460. doi: 10.4103/njcp.njcp_160_18.
PubMed 30417844Akbay Oba A, Dulgergil CT, Sonmez IS. Prevalence of dental anxiety in 7- to 11-year-old children and its relationship to dental caries. Med Princ Pract. 2009;18(6):453-7. doi: 10.1159/000235894. Epub 2009 Sep 30.
PubMed 19797921Wigen TI, Skaret E, Wang NJ. Dental avoidance behaviour in parent and child as risk indicators for caries in 5-year-old children. Int J Paediatr Dent. 2009 Nov;19(6):431-7. doi: 10.1111/j.1365-263X.2009.01014.x. Epub 2009 Aug 25.
PubMed 19708863Shim YS, Kim AH, Jeon EY, An SY. Dental fear & anxiety and dental pain in children and adolescents; a systemic review. J Dent Anesth Pain Med. 2015 Jun;15(2):53-61. doi: 10.17245/jdapm.2015.15.2.53. Epub 2015 Jun 30.
PubMed 28879259American Academy of Pediatric Dentistry. Behavior guidance for the pediatric dental patient. The Reference Manual of Pediatric Dentistry. Chicago, Ill.: American Academy of Pediatric Dentistry; 2023:359-77.
Liu Y, Gu Z, Wang Y, Wu Q, Chen V, Xu X, Zhou X. Effect of audiovisual distraction on the management of dental anxiety in children: A systematic review. Int J Paediatr Dent. 2019 Jan;29(1):14-21. doi: 10.1111/ipd.12430. Epub 2018 Oct 26.
PubMed 30362187Charowski M, Wells MH, Dormois L, Fernandez JA, Scarbecz M, Maclin M. A Randomized Controlled Pilot Study Examining Effects of Animal Assisted Therapy in Children Undergoing Sealant Placement. Pediatr Dent. 2021 Jan 15;43(1):10-16.
PubMed 33662243
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Robot-pets in Reducing Dental Anxiety in Children: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06243705
- Acronym / sponsor ID
- ADUDHF-2023/23
- Conditions
- Dental Anxiety
- Keywords
- Behaviour management, Robot pet, Dental anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study will be used a parallel-group randomized controlled trial design. Children fulfilling the inclusion criteria will be randomized to three group. Fissure sealants will be applied to the children using the distraction technique determined by randomisation.
| Arm | Type | Receives |
|---|---|---|
| Robot-Pet Group | Experimental | Device: Robot-PetThe 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). |
| Virtual Reality Glasses Group | Active comparator | Device: Virtual Reality GlassesDuring 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). |
| Control Group | No intervention | –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). |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-PetThe robot-pet makes sounds like a real cat and responds to touch and petting | Device | Robot-Pet Group |
| Virtual Reality GlassesVR 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 | Device | Virtual Reality Glasses Group |
Primary outcome
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.
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))
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
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).
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).
4 secondary outcomes
Evaluate the Child's Perspectives on the Use of Robot-Pet
Time frame: Immediately After Treatment
Assesment of Parents' Perspectives on the Use of Robot-Pet
Time frame: Immediately After Treatment
Evaluate the Child's Perspectives on the Use of Virtual Reality Glasses
Time frame: Immediately After Treatment
Assesment of Parents' Perspectives on the use Virtual Reality Glasses
Time frame: Immediately After Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- BackgroundGilchrist F, Campbell C. Communication and the Use of Language. In: Dental Fear and Anxiety in Pediatric Patients. Cham: Springer International Publishing; 2017. p. 117-36.
- Background: PubMed 26153526Gilchrist F, Marshman Z, Deery C, Rodd HD. The impact of dental caries on children and young people: what they have to say? Int J Paediatr Dent. 2015 Sep;25(5):327-38. doi: 10.1111/ipd.12186. Epub 2015 Jul 8.
- Background: PubMed 30417844Alsadat FA, El-Housseiny AA, Alamoudi NM, Elderwi DA, Ainosa AM, Dardeer FM. Dental fear in primary school children and its relation to dental caries. Niger J Clin Pract. 2018 Nov;21(11):1454-1460. doi: 10.4103/njcp.njcp_160_18.
- Background: PubMed 19797921Akbay Oba A, Dulgergil CT, Sonmez IS. Prevalence of dental anxiety in 7- to 11-year-old children and its relationship to dental caries. Med Princ Pract. 2009;18(6):453-7. doi: 10.1159/000235894. Epub 2009 Sep 30.
- Background: PubMed 19708863Wigen TI, Skaret E, Wang NJ. Dental avoidance behaviour in parent and child as risk indicators for caries in 5-year-old children. Int J Paediatr Dent. 2009 Nov;19(6):431-7. doi: 10.1111/j.1365-263X.2009.01014.x. Epub 2009 Aug 25.
- Background: PubMed 28879259Shim YS, Kim AH, Jeon EY, An SY. Dental fear & anxiety and dental pain in children and adolescents; a systemic review. J Dent Anesth Pain Med. 2015 Jun;15(2):53-61. doi: 10.17245/jdapm.2015.15.2.53. Epub 2015 Jun 30.
- BackgroundAmerican Academy of Pediatric Dentistry. Behavior guidance for the pediatric dental patient. The Reference Manual of Pediatric Dentistry. Chicago, Ill.: American Academy of Pediatric Dentistry; 2023:359-77.
- Background: PubMed 30362187Liu Y, Gu Z, Wang Y, Wu Q, Chen V, Xu X, Zhou X. Effect of audiovisual distraction on the management of dental anxiety in children: A systematic review. Int J Paediatr Dent. 2019 Jan;29(1):14-21. doi: 10.1111/ipd.12430. Epub 2018 Oct 26.
- Background: PubMed 33662243Charowski M, Wells MH, Dormois L, Fernandez JA, Scarbecz M, Maclin M. A Randomized Controlled Pilot Study Examining Effects of Animal Assisted Therapy in Children Undergoing Sealant Placement. Pediatr Dent. 2021 Jan 15;43(1):10-16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melis AKYILDIZ, PhD study director
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Pet and Virtual Reality Glasses in people with Dental Anxiety, run by Aydin Adnan Menderes 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?
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 7 Aug 2024. 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. 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?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06243705, which also lists 9 linked publications.
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 7 Aug 2024.