Dog-Assisted Therapy in Children During Blood or Dental Extraction.

Emotional Stress Clinical Trial

— Extra-can  

Official title:

Efficacy Study of Dog-Assisted Therapy in Children During Blood or Dental Extraction: Extra-can Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06468111
• Other study ID #: DMP ID: 2163
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Contact: Esther Rodrigo Claverol, MD
• Phone: 0034973272446
• Email: erodrigo.lleida.ics[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Stress
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
Spain	Centre d'Atenció Primària Primer de Maig	Lleida

Sponsors (2)

Lead Sponsor	Collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina	Public Health Service of Cataluña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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.
Secondary	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.