Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05727527
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2023-02-05
Brief Title:
Effect of a Candy Flavoring Before Local Anesthesia on Anxiety and Pain Perception in Children
Sponsor:
King Abdullah University Hospital
Organization:
King Abdullah University Hospital
Study Overview
Official Title:
The Effect of Using a Sugar-free Candy Flavoring Before Local Anesthesia Injection on Anxiety and Pain Perception in Children a Split-mouth Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-05
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:
This is a randomized clinical trial that aimed to test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception when compared to a negative control group Applying the flavor before injecting local anesthesia helped in distracting the child and reduced the associated pain
Detailed Description:
Background Distraction techniques can be very useful in managing children on the dental chair and to guide their attention away from a painful stimulus No studies so far have used a sugar-free solution as a distraction method
Aim To test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception and anxiety when compared to negative control group using a split-mouth randomized study design
Methods A total of 84 children aged 4-9 years with no previous dental experience and require the same treatment on the upper primary first or second molars bilaterally were included in this study Each child received two injections The children were randomly allocated into two groups group 1 received the first injection after applying a flavor and group 2 received the first injection after applying sterile water The children received the first injection either on the right or left side and switched sides on the next visit resulting in n168 total injections The observed pain perception was assessed using the SEM scale Wong-Baker Faces pain rating scale will be used to assess the pain reported by the child Pulse rate BMI and sweet taste preference were also recorded by an independent observer to ensure blinding
Results Using a sugar-free candy flavor before injecting local anesthesia helps in reducing pain accompanying local anesthesia
Aim To test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception and anxiety when compared to negative control group using a split-mouth randomized study design
Methods A total of 84 children aged 4-9 years with no previous dental experience and require the same treatment on the upper primary first or second molars bilaterally were included in this study Each child received two injections The children were randomly allocated into two groups group 1 received the first injection after applying a flavor and group 2 received the first injection after applying sterile water The children received the first injection either on the right or left side and switched sides on the next visit resulting in n168 total injections The observed pain perception was assessed using the SEM scale Wong-Baker Faces pain rating scale will be used to assess the pain reported by the child Pulse rate BMI and sweet taste preference were also recorded by an independent observer to ensure blinding
Results Using a sugar-free candy flavor before injecting local anesthesia helps in reducing pain accompanying local anesthesia
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