An interventional study of Animal Assisted Therapy in Emotional Stress, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Recruiting at 1 site in Spain. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Health services research
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.
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.
844 studies on the registry are indexed under Stress, Psychological; 136 are open to participants now.
This study's planned enrollment of 120 is above the median of 84 across 688 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 161 studies on the registry; 21 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The control group underwent a blood and dental extraction will be performed according to the usual protocol of the health center.
Behavioral: 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.
Behavioral: Animal Assisted Therapy
Blood and dental extraction will be performed according to the usual protocol of the health center in both groups; with the additional assistance of the therapy dog in experimental group.
Also known as: Dog Assisted Therapy
Observation Scale of Behavioral Distress (OSBD) registered 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
Time frame: This scale registered behaviors in continuous 15-second intervals at baseline, during and immediately after the intervention
State-Trait Anxiety Inventory Questionnaire (STAI) registered at baseline and immediately after the intervention
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.
Time frame: This questionnaire will be administered at baseline and immediately after the intervention, post-extraction.
Wong-Baker Faces Scale registered at baseline and immediately after the intervention
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.
Time frame: This scale will be administered at baseline and immediately after the intervention, post-extraction.
Evaluation questionnaire for health professionals administered immediately after the intervention
This is a questionnaire that will be completed by the professionals (nursing or dentist) at the end of the intervention. Using a Likert scale from 0 to 10 (0= Not at all and 10= A lot). It contains the following questions: * Did you find it stressful to do the extraction? (CG+EG) * How relaxed you have seen the child? (CG+EG) * How calm have you seen the parents? (CG+EG) * Did the presence of the dog make the extraction easier? (EG) * Do you consider that the dog reduces the risk of accidents during extraction? (EG) * Has the presence of the dog interfered with your work? (EG)
Time frame: This questionnaire will be administered immediately after the intervention, post-extraction
Parent satisfaction questionnaire administered immediately after the intervention
The following questions will be asked in writing and answered by parents.Using a Likert scale from 0 to 10 (0= Not at all and 10= A lot). It contains the following questions: * Have you experienced this procedure (extraction) in a stressful way? (CG+EG) * How relaxed have you seen the child? (CG+EG) * In terms of satisfaction, how would you rate this procedure? (CG+EG) * Has the presence of the dog made the child feel calmer? (EG) * Has the presence of the dog made you feel calmer? (EG) * Do you think that the child has experienced the extraction as a less aggressive activity because of the presence of the dog? (EG) * Would you recommend this experience to other parents to do with their children? (EG)
Time frame: This questionnaire will be administered immediately after the intervention, post-extraction
Plan to share: No
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