Dog-Assisted Therapy in Children During Blood or Dental Extraction.
NCT Number: NCT06468111
Acronym: Extra-can
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emotional Stress
Interventions: BEHAVIORAL: Animal Assisted Therapy
Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators: Public Health Service of Cataluña
Sex: ALL
Age: CHILD
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2022-01-01
Completion Date: 2025-06-30
Locations: Centre d'Atenció Primària Primer de Maig, Lleida, 25000, Spain

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.

Primary Outcome Measures: 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, This scale registered behaviors in continuous 15-second intervals at baseline, during and immediately after the intervention
Secondary Outcome Measures: 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., 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., This scale will be administered at baseline and immediately after the intervention, post-extraction.
Other Outcome Measures: 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), 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), This questionnaire will be administered immediately after the intervention, post-extraction