Dog-Assisted Therapy in Children During Blood or Dental Extraction. (Extra-can)

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Enrolling

Conditions: Emotional Stress

Treatments: Behavioral: Animal Assisted Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06468111

DMP ID: 2163

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Control group

Active Comparator group

Description:

The control group underwent a blood and dental extraction will be performed according to the usual protocol of the health center.

Treatment:

Behavioral: Animal Assisted Therapy

experimental group

Experimental group

Description:

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.

Treatment:

Behavioral: Animal Assisted Therapy