Ignite Creation Date:
2024-07-17 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468111
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-09
Brief Title:
Dog-Assisted Therapy in Children During Blood or Dental Extraction
Sponsor:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Study Overview
Official Title:
Efficacy Study of Dog-Assisted Therapy in Children During Blood or Dental Extraction Extra-can Project
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Extra-can
Brief Summary:
The purpose of the present study is to evaluate the efficacy of Animal Assisted Therapy AAT during blood extraction or dental procedures in a Primary Care Pediatric Service Determine the improvement in facilitating the task of venipuncture or dental extraction for nursing or dental professionals Estimate the reduction in the childs emotional stress during these procedures with the support of a therapy dog Evaluate the emotional stress in the accompanying family member These objectives will be accomplished through a randomized open label two-arm controlled study of AAT for children who need a blood or dental extraction
Detailed Description:
INTRODUCTION Venous puncture for routine blood sampling can be distressing for many children leading to heightened anxiety both before and during the procedure Dental anxiety affects around 9 of European children and adolescents potentially persisting into adulthood and resulting in dental avoidance behaviors Animal-assisted therapy AAT is viewed as a distraction technique that could play a vital role in managing pain and distress for children AAT is a planned structured therapeutic intervention with specific goals facilitated by healthcare professionals
OBJECTIVES Evaluate the efficacy of AAT during blood or dental extraction in a Primary Care Pediatric Service Determine the improvement in facilitating the task of venipuncture or dental extraction for nursing or dental professionals Estimate the reduction in the childs emotional stress during these procedures with the support of a therapy dog Evaluate the emotional stress in the accompanying family member
METHODOLOGY Randomized two-arm clinical trial control group and intervention group involving children aged 3 to 8 requiring blood analysis or dental extraction in a Primary Health Care Center Patients will be randomly assigned to the control and intervention groups Sample size calculations suggest 60 patients in each group to detect statistically significant differences The control group follows standard protocols while the intervention group includes AAT with 10 minutes of pre-procedure interaction with the therapy dog extraction performed with the therapy dog and 5 minutes of post-procedure interaction Personnel includes nurses or dentists a pediatrician and an AAT technician Response variables include various scales measuring anxiety and distress while control variables encompass age gender pathologies extraction type and pet ownership
EXPECTED RESULTS The implementation of AAT as an emotional support intervention utilizing a therapy dog for distraction is anticipated to improve symptomatology in the intervention group by reducing fear and anxiety post-procedure
OBJECTIVES Evaluate the efficacy of AAT during blood or dental extraction in a Primary Care Pediatric Service Determine the improvement in facilitating the task of venipuncture or dental extraction for nursing or dental professionals Estimate the reduction in the childs emotional stress during these procedures with the support of a therapy dog Evaluate the emotional stress in the accompanying family member
METHODOLOGY Randomized two-arm clinical trial control group and intervention group involving children aged 3 to 8 requiring blood analysis or dental extraction in a Primary Health Care Center Patients will be randomly assigned to the control and intervention groups Sample size calculations suggest 60 patients in each group to detect statistically significant differences The control group follows standard protocols while the intervention group includes AAT with 10 minutes of pre-procedure interaction with the therapy dog extraction performed with the therapy dog and 5 minutes of post-procedure interaction Personnel includes nurses or dentists a pediatrician and an AAT technician Response variables include various scales measuring anxiety and distress while control variables encompass age gender pathologies extraction type and pet ownership
EXPECTED RESULTS The implementation of AAT as an emotional support intervention utilizing a therapy dog for distraction is anticipated to improve symptomatology in the intervention group by reducing fear and anxiety post-procedure
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