Clinical trial NCT06468111: Dog-Assisted Therapy in Children During Blood or Dental Extraction.
Official title: Efficacy Study of Dog-Assisted Therapy in Children During Blood or Dental Extraction: Extra-can Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotional Stress
Keywords: Animal-assisted Intervention
Children
Primary Healthcare Centre
Venipuncture
Dental fear
Distraction emotional support animals
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Public Health Service of Cataluña
First posted: 2024-06-21
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, open-label, two-arm clinical trial.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Observation Scale of Behavioral Distress (OSBD) registered at baseline, during and immediately after the intervention
timeFrame: This scale registered behaviors in continuous 15-second intervals at baseline, during and immediately after the intervention
Secondary outcomes:
measure: State-Trait Anxiety Inventory Questionnaire (STAI) registered at baseline and immediately after the intervention
timeFrame: This questionnaire will be administered at baseline and immediately after the intervention, post-extraction.
measure: Wong-Baker Faces Scale registered at baseline and immediately after the intervention
timeFrame: This scale will be administered at baseline and immediately after the intervention, post-extraction.
Other outcomes:
measure: Evaluation questionnaire for health professionals administered immediately after the intervention
timeFrame: This questionnaire will be administered immediately after the intervention, post-extraction
measure: Parent satisfaction questionnaire administered immediately after the intervention
timeFrame: This questionnaire will be administered immediately after the intervention, post-extraction
Locations:
city: Lleida
country: Spain
facility: Centre d'Atenció Primària Primer de Maig
Study officials:
affiliation: IDIAP JORDI GOL
name: Marta Ortega Bravo, PhD
role: STUDY_DIRECTOR
References: