Effectiveness of Robot-pets in Reducing Dental Anxiety in Children

NCT06243705 | Completed DMC

• 1 other identifier: ADUDHF-2023/23
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Anxiety

Keywords

Behaviour management; Robot pet; Dental anxiety

Outcome Measures

Primary Outcomes (5)

• 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.

  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))

  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

  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. 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

  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 Outcomes (4)

• Evaluate the Child's Perspectives on the Use of Robot-Pet

  Immediately After Treatment

• Assesment of Parents' Perspectives on the Use of Robot-Pet

  Immediately After Treatment

• Evaluate the Child's Perspectives on the Use of Virtual Reality Glasses

  Immediately After Treatment

• Assesment of Parents' Perspectives on the use Virtual Reality Glasses

  Immediately After Treatment

Study Arms (3)

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).

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).

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).

Interventions

Robot-Pet DEVICE

The robot-pet makes sounds like a real cat and responds to touch and petting

Robot-Pet Group

Virtual Reality Glasses DEVICE

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

Virtual Reality Glasses Group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify 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

You may not qualify 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)

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Melis AKYILDIZ

Aydin, Efeler, 09100, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  BACKGROUND

• 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.

  PMID: 26153526 BACKGROUND

• Alsadat 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.

  PMID: 30417844 BACKGROUND

• Akbay 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.

  PMID: 19797921 BACKGROUND

• Wigen 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.

  PMID: 19708863 BACKGROUND

• Shim 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.

  PMID: 28879259 BACKGROUND

• American 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

• 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.

  PMID: 30362187 BACKGROUND

• Charowski 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.

  PMID: 33662243 BACKGROUND

Study Officials

• Melis AKYILDIZ, PhD

  Aydin Adnan Menderes University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Doctoral Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 6, 2024
• Study Start: October 2, 2023
• Primary Completion: May 3, 2024
• Study Completion: May 17, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

TU (1)