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

NCT06468111 | Recruiting DMC

• 1 other identifier: DMP ID: 2163
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emotional Stress

Keywords

Animal-assisted Intervention; Children; Primary Healthcare Centre; Venipuncture; Dental fear; Distraction emotional support animals

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• State-Trait Anxiety Inventory Questionnaire (STAI) registered at baseline and immediately after the intervention

  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

  This scale will be administered at baseline and immediately after the intervention, post-extraction.

Other Outcomes (2)

• Evaluation questionnaire for health professionals administered immediately after the intervention

  This questionnaire will be administered immediately after the intervention, post-extraction

• Parent satisfaction questionnaire administered immediately after the intervention

  This questionnaire will be administered immediately after the intervention, post-extraction

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

experimental group

EXPERIMENTAL

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

Interventions

Animal Assisted Therapy BEHAVIORAL

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

Control group; experimental group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Public Health Service of Cataluña: collaborator

Study Sites (1)

Centre d'Atenció Primària Primer de Maig

Lleida, 25000, Spain

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Marta Ortega Bravo, PhD

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  STUDY DIRECTOR

Central Study Contacts

Esther Rodrigo Claverol, MD

CONTACT

0034973272446; erodrigo.lleida.ics@gencat.cat

Esther Rodrigo Claverol, MD

CONTACT

0034977272446; erodrigo.lleida.ics@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate in Medicine

Model Details: Randomized, controlled, open-label, two-arm clinical trial.

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 21, 2024
• Study Start: January 1, 2022
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)