Dog-Assisted Therapy in Children During Blood or Dental Extraction.
- Conditions
- Emotional Stress
- Interventions
- Behavioral: Animal Assisted Therapy
- Registration Number
- NCT06468111
- Lead Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- 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 child's 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 child's 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Age between 3 and 12 years old.
- Need a blood or dental extraction.
- Willing to participate in the study on a voluntary basis.
- Delivery of the information sheet and signature the informed consent.
- If in the initial interview they declared having allergy or fear of dogs.
- Have aggression disorder towards dogs.
- Not want to participate in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Animal Assisted Therapy The control group underwent a blood and dental extraction will be performed according to the usual protocol of the health center. experimental group Animal Assisted Therapy The experimental group underwent a blood and dental extraction will be performed according to the usual protocol of the health center, the same as control group, and in addition dog-assisted therapy will be performed. Intervention (with the additional assistance of the therapy dog). 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.
- Primary Outcome Measures
Name Time Method Observation Scale of Behavioral Distress (OSBD) registered at baseline, during and immediately after the intervention This scale registered behaviors in continuous 15-second intervals at baseline, during and immediately after the intervention Is an instrument for measuring children's distress during painful medical procedures, assessed by an external observer. It is a 4-point Likert-type scale instrument (where the numerical values are weighted from 0 (not at all) to 3 (very much)) that evaluates 11 different behaviors
- Secondary Outcome Measures
Name Time Method State-Trait Anxiety Inventory Questionnaire (STAI) registered at baseline and immediately after the intervention This questionnaire will be administered at baseline and immediately after the intervention, post-extraction. Is a self-administered questionnaire that assesses the levels of clinical anxiety (both trait anxiety ("most of the time") and state anxiety ("at the present moment")). The total score on each of the subscales ranges from 0 to 60 points.
Wong-Baker Faces Scale registered at baseline and immediately after the intervention This scale will be administered at baseline and immediately after the intervention, post-extraction. Is a tool that uses a combination of faces, numbers, and words to help a person effectively communicate the severity of their physical pain. A 0 point 'happy face' represents the absence or lack of pain. A 10 point 'crying face' represents the worst possible or most excruciating pain. All the faces in between represent a scoring of 2, 4, 6, or 8, respectively, based on the pain severity facial image chosen.
Trial Locations
- Locations (1)
Centre d'Atenció Primària Primer de Maig
🇪🇸Lleida, Spain