Emotional StressExtra-canNCT06468111
Dog-Assisted Therapy in Children During Blood or Dental Extraction.
A study testing Animal Assisted Therapy in people with Emotional Stress, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Emotional Stress
- What is being tested?
- Animal Assisted Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Centre d'Atenció Primària Primer de Maig
Lleida, 25000
Esther Rodrigo Claverol, MD, 0034973272446, erodrigo.lleida.ics@gencat.cat
About this study
Official title: Efficacy Study of Dog-Assisted Therapy in Children During Blood or Dental Extraction: Extra-can Project
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.
Read the detailed 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.
- Conditions
- Emotional Stress
- Being tested
- Animal Assisted Therapy
- Keywords
- Animal-assisted Intervention, Children, Primary Healthcare Centre, Venipuncture, Dental fear, Distraction emotional support animals
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal Assisted TherapyBehavioural
Also called Dog 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Animal Assisted Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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.
Measured: This scale will be administered at baseline and immediately after the intervention, post-extraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jan 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, open-label, two-arm clinical trial.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Service of Cataluña
- Responsible party
- Principal investigator, Esther Rodrigo Claverol, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Investigators
- Marta Ortega Bravo, PhD, Study director, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468111
- Sponsor's protocol ID
- DMP ID: 2163
- Acronym
- Extra-can
- Status last verified
- Sep 2025
- First submitted
- 9 Jun 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Dog-Assisted Therapy in Children During Blood or Dental Extraction: Extra-can Project
- ClinicalTrials.gov ID
- NCT06468111
- Acronym / sponsor ID
- Extra-can / DMP ID: 2163
- Conditions
- Emotional Stress
- Keywords
- Animal-assisted Intervention, Children, Primary Healthcare Centre, Venipuncture, Dental fear, Distraction emotional support animals
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Public Health Service of Cataluña
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, open-label, two-arm clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Animal Assisted TherapyThe control group underwent a blood and dental extraction will be performed according to the usual protocol of the health center. |
| experimental group | Experimental | Behavioral: Animal Assisted TherapyThe 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. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal Assisted TherapyAlso: Dog Assisted TherapyBlood 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. | Behavioural | Control group, experimental group |
Primary outcome
Observation Scale of Behavioral Distress (OSBD) registered at baseline, during and immediately after the intervention
Time frame: This scale registered behaviors in continuous 15-second intervals 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
2 secondary outcomes
State-Trait Anxiety Inventory Questionnaire (STAI) registered at baseline and immediately after the intervention
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
Time frame: This scale will be administered at baseline and immediately after the intervention, post-extraction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Ortega Bravo, PhD study director
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal Assisted Therapy in people with Emotional Stress, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esther Rodrigo Claverol, MD (0034973272446, erodrigo.lleida.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observation Scale of Behavioral Distress (OSBD) registered at baseline, during and immediately after the intervention (time frame: This scale registered behaviors in continuous 15-second intervals at baseline, during and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.