Clinical trial NCT06243705: Effectiveness of Robot-pets in Reducing Dental Anxiety in Children
Official title: Assessing the Effectiveness of Robot-pets in Reducing Dental Anxiety in Children: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Keywords: Behaviour management
Robot pet
Dental anxiety
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 72
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Assesment of Heart Rate and Oxygen Saturations
timeFrame: Before Treatment, During Fissure Sealant Application-Surface Cleaning Phase, During Fissure Sealant Application-Isolation Phase, During Fissure Sealant Application-Washing Phase, Immediately After Treatment
measure: Assesment of Behaviour- Frankl Behaviour Rating Scale
timeFrame: Before Treatment, Immediately After Treatment
measure: Assesment Of Behaviour- Modified Houpt Behaviour Rating Scale
timeFrame: During Fissure Sealant Application-Surface Cleaning Phase, During Fissure Sealant Application-Isolation Phase, During Fissure Sealant Application-Washing Phase
measure: Assesment of Dental Anxiety- Children's Fear Survey Schedule-Dental Subscale
timeFrame: Before Treatment, Immediately After Treatment
measure: Assesment of Dental Anxiety- Facial Image Scale
timeFrame: Before Treatment, Immediately After Treatment
Secondary outcomes:
measure: Evaluate the Child's Perspectives on the Use of Robot-Pet
timeFrame: Immediately After Treatment
measure: Assesment of Parents' Perspectives on the Use of Robot-Pet
timeFrame: Immediately After Treatment
measure: Evaluate the Child's Perspectives on the Use of Virtual Reality Glasses
timeFrame: Immediately After Treatment
measure: Assesment of Parents' Perspectives on the use Virtual Reality Glasses
timeFrame: Immediately After Treatment
Other outcomes:
Locations:
city: Aydin
country: Turkey
facility: Melis AKYILDIZ
state: Efeler
Study officials:
affiliation: Aydin Adnan Menderes University
name: Melis AKYILDIZ, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.