Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06243705
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2024-01-25
Brief Title:
Effectiveness of Robot-pets in Reducing Dental Anxiety in Children
Sponsor:
Aydin Adnan Menderes University
Organization:
Aydin Adnan Menderes University
Study Overview
Official Title:
Assessing the Effectiveness of Robot-pets in Reducing Dental Anxiety in Children A Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childrens perceptions regarding the use of a robot-pet
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 childrens 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 childrens 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 childs 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 childrens 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 catdog 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 childrens 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-2Virtual 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 Childrens 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 PostoperativeT3 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 scalesFBRSMHS 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 techniqueT3
Statistical Analyses
The IBM SPSS Statistics for Windows Version 250 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 Dunnetts T3 method for pairwise comparisonsAll hypothesis tests will be conducted at a significance level of 005
Basic behavior management strategies are commonly employed in dental offices to shape a childs 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 childrens 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 catdog 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 childrens 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-2Virtual 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 Childrens 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 PostoperativeT3 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 scalesFBRSMHS 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 techniqueT3
Statistical Analyses
The IBM SPSS Statistics for Windows Version 250 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 Dunnetts T3 method for pairwise comparisonsAll hypothesis tests will be conducted at a significance level of 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None