Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326307
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2024-03-05
Brief Title:
Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures
Sponsor:
King Abdulaziz University
Organization:
King Abdulaziz University
Study Overview
Official Title:
Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures Randomized Clinical Crossover Trial
Status:
COMPLETED
Status Verified Date:
2024-03
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:
The goal of this RCT is to compare puppet modeling technique vs tell show and do on children undergoing stressful dental procedures
The main questions it aims to answer are
1 To compare the effect of puppet modeling vs tell show and do on the cooperation of children during the administration of local anesthesia
2 To compare the effect of puppet modeling vs tell show and do on the anxiety level of children during the administration of local anesthesia
type of study clinical trial participant populationhealth conditions Healthy
In this randomized crossover clinical trial study subjects were randomly allocated into two groups
Group I Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit 2 weeks later P-TSD
Group II Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit 2 weeks laterTSD-P
The main questions it aims to answer are
1 To compare the effect of puppet modeling vs tell show and do on the cooperation of children during the administration of local anesthesia
2 To compare the effect of puppet modeling vs tell show and do on the anxiety level of children during the administration of local anesthesia
type of study clinical trial participant populationhealth conditions Healthy
In this randomized crossover clinical trial study subjects were randomly allocated into two groups
Group I Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit 2 weeks later P-TSD
Group II Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit 2 weeks laterTSD-P
Detailed Description:
Aim of the Study The aim of this research is to compare the effectiveness of tell show and do TSD vs puppet play therapy on childrens behavior during the administration of local anesthesia
Materials and Methods This was a randomized crossover clinical trail that was conducted at King Abdulaziz University Faculty of Dentistry for a period of 12 months starting from Jan 2023 to Dec 2023 on 41 children aged 3-7 years randomly divided into two groups of Group I 23 children Children who received the TSD behavior guidance during their first visit and puppet play therapy in their second visit 2 weeks later Group II 18 children Children who received puppet play therapy during their first visit and TSD guidance in their second visit 2 weeks later The anxiety level was determined using Facial Index ScaleFIS and Venham anxiety rating scale and pulse rate PR at the beginning middle and the end of each anesthesia administration Patient behavior was also scored using Frankl behavior rating scale FBRS Venham behavior rating scale The FLACC scale was used to assess pain
Materials and Methods This was a randomized crossover clinical trail that was conducted at King Abdulaziz University Faculty of Dentistry for a period of 12 months starting from Jan 2023 to Dec 2023 on 41 children aged 3-7 years randomly divided into two groups of Group I 23 children Children who received the TSD behavior guidance during their first visit and puppet play therapy in their second visit 2 weeks later Group II 18 children Children who received puppet play therapy during their first visit and TSD guidance in their second visit 2 weeks later The anxiety level was determined using Facial Index ScaleFIS and Venham anxiety rating scale and pulse rate PR at the beginning middle and the end of each anesthesia administration Patient behavior was also scored using Frankl behavior rating scale FBRS Venham behavior rating scale The FLACC scale was used to assess pain
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