Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-05-04 @ 2:20 PM
Study NCT ID:
NCT07398105
Status:
COMPLETED
Last Update Posted:
2026-02-09
First Post:
2026-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Virtual Reality and Mixed Reality Head-Mounted Displays for Dental Anxiety Control During Local Anesthesia in Children
Sponsor:
Selcuk University
Organization:
Study Overview
Official Title:
A Clinical Study Comparing Virtual Reality and Mixed Reality Head-Mounted Displays for Dental Anxiety and Pain Control During Local Anesthesia in Children
Status:
COMPLETED
Status Verified Date:
2026-02
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 common problem in children and may negatively affect cooperation, pain perception, and treatment success during dental procedures. Distraction techniques are widely used to reduce anxiety during dental treatment. In recent years, virtual reality (VR) and mixed reality (MR) technologies have been introduced as innovative audiovisual distraction methods in pediatric dentistry.
The aim of this randomized clinical study is to compare the effects of virtual reality and mixed reality head-mounted displays on dental anxiety and pain perception in children during local anesthesia administration. A total of 142 systemically healthy children aged 6 to 12 years who required dental treatment under local anesthesia were included. Participants were randomly assigned to either a VR group or an MR group.
Dental anxiety and pain levels were assessed using validated scales before and during local anesthesia administration. Behavioral responses and physiological parameters were also recorded. The results of this study will help determine whether VR or MR provides superior anxiety control during pediatric dental procedures.
The aim of this randomized clinical study is to compare the effects of virtual reality and mixed reality head-mounted displays on dental anxiety and pain perception in children during local anesthesia administration. A total of 142 systemically healthy children aged 6 to 12 years who required dental treatment under local anesthesia were included. Participants were randomly assigned to either a VR group or an MR group.
Dental anxiety and pain levels were assessed using validated scales before and during local anesthesia administration. Behavioral responses and physiological parameters were also recorded. The results of this study will help determine whether VR or MR provides superior anxiety control during pediatric dental procedures.
Detailed Description:
Dental anxiety in children is associated with increased pain perception, behavioral problems, and reduced treatment compliance. Managing anxiety during dental procedures is therefore a critical component of pediatric dental care. Conventional behavior guidance techniques may not always be sufficient, particularly during invasive procedures such as local anesthesia administration.
This randomized, parallel-group clinical trial was conducted to compare the effects of virtual reality (VR) and mixed reality (MR) head-mounted displays on dental anxiety and pain perception in pediatric patients. The study included 142 systemically healthy children aged between 6 and 12 years who required dental treatment under local anesthesia. Only children with positive or definitely positive behavior according to the Frankl Behavior Rating Scale were included.
Participants were randomly allocated into two groups: a VR group and an MR group. During local anesthesia administration, children in the VR group were exposed to a fully immersive virtual environment, while children in the MR group interacted with virtual content while maintaining partial awareness of the clinical environment.
Dental anxiety was evaluated using the Children's Fear Survey Schedule-Dental Subscale, and pain perception was assessed using the Wong-Baker FACES Pain Rating Scale. Behavioral pain responses during local anesthesia were scored using the FLACC scale by two independent observers. Heart rate measurements were recorded as a physiological indicator of anxiety. Interobserver reliability for behavioral assessments was also evaluated.
The primary outcome of the study was the change in dental anxiety levels during local anesthesia administration. Secondary outcomes included pain perception, behavioral responses, and physiological changes. The findings of this study aim to provide evidence regarding the effectiveness of VR and MR technologies as distraction tools for anxiety management in pediatric dentistry.
This randomized, parallel-group clinical trial was conducted to compare the effects of virtual reality (VR) and mixed reality (MR) head-mounted displays on dental anxiety and pain perception in pediatric patients. The study included 142 systemically healthy children aged between 6 and 12 years who required dental treatment under local anesthesia. Only children with positive or definitely positive behavior according to the Frankl Behavior Rating Scale were included.
Participants were randomly allocated into two groups: a VR group and an MR group. During local anesthesia administration, children in the VR group were exposed to a fully immersive virtual environment, while children in the MR group interacted with virtual content while maintaining partial awareness of the clinical environment.
Dental anxiety was evaluated using the Children's Fear Survey Schedule-Dental Subscale, and pain perception was assessed using the Wong-Baker FACES Pain Rating Scale. Behavioral pain responses during local anesthesia were scored using the FLACC scale by two independent observers. Heart rate measurements were recorded as a physiological indicator of anxiety. Interobserver reliability for behavioral assessments was also evaluated.
The primary outcome of the study was the change in dental anxiety levels during local anesthesia administration. Secondary outcomes included pain perception, behavioral responses, and physiological changes. The findings of this study aim to provide evidence regarding the effectiveness of VR and MR technologies as distraction tools for anxiety management in pediatric dentistry.
Study Oversight
Has Oversight DMC:
False
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?: