About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Parallel
Treatments tested in this trial
Animal Assisted Therapy
BehavioralBlood 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
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.
Other outcomes
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)
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)
Sponsors and contacts
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead sponsor
Public Health Service of Cataluña
Collaborator